Effect of 5-Minute Movies Shown via a Mobile Phone App on Risk Factors and Mortality After Stroke in a Low- to Middle-Income Country: Randomized Controlled Trial for the Stroke Caregiver Dyad Education Intervention (Movies4Stroke)

Background Pakistan is the sixth most populous nation in the world and has an estimated 4 million stroke survivors. Most survivors are taken care of by community-based caregivers, and there are no inpatient rehabilitation facilities. Objective The objective of this study was to evaluate the effectiveness and safety of locally designed 5-min movies rolled out in order of relevance that are thematically delivered in a 3-month program to deliver poststroke education to stroke survivor and caregiver dyads returning to the community. Methods This study was a randomized controlled, outcome assessor–blinded, parallel group, single-center superiority trial in which participants (stroke survivor-caregiver dyads) with first-ever stroke (both ischemic and hemorrhagic) incidence were randomized within 48 hours of their stroke into either the video-based education intervention group or the control group. The video-based education intervention group had health education delivered through short videos that were shown to the participants and their caregivers at the time of admission, before discharge, and the first and third months of follow-up after discharge. The control group had standardized care including predischarge education and counseling according to defined protocols. All participants enrolled in the video education intervention and control groups were followed for 12 months after discharge for outcome assessment in the outpatient stroke clinics. The primary outcome measures were the proportion of participants achieving control of blood pressure, blood sugar, and blood cholesterol in the video intervention versus the control group. Several predefined secondary outcomes were included in this study, of which we report the mortality and functional disability in this paper. Analysis was by performed using the intention-to-treat principle. Results A total of 310 stroke survivors and their caregiver dyads (participant dyads) were recruited over a duration of 6 months. In total, 155 participant dyads were randomized into the intervention and control groups, each. The primary outcome of control of three major risk factors revealed that at 12 months, there was a greater percentage of participants with a systolic BP<125 mm Hg (18/54, 33% vs 11/52, 21%; P=.16), diastolic BP<85 mm Hg (44/54, 81% vs 37/52, 71%; P=.21), HbA1c level<7% (36/55, 65% vs 30/40, 75%; P=.32), and low-density lipoprotein level<100 mg/dL (36/51, 70% vs 30/45, 67%; P=.68) in the intervention group than in the control group. The secondary outcome reported is the mortality among the stroke survivors because the number of stroke-related complications was higher in the control group than in the intervention group (13/155, 8.4% vs 2/155, 1.3%), and this difference was statistically significant (P<.001). Conclusions The Movies4Stroke trial failed to achieve its primary specified outcome. However, secondary outcomes that directly related to survival skills of stroke survivors demonstrated the effectiveness of the video-based intervention on improving stroke-related mortality and survival without disability. Trial Registration ClinicalTrials.gov NCT02202330; https://www.clinicaltrials.gov/ct2/show/NCT02202330

Is this a full powered effectiveness trial or a pilot/feasibility trial? * Manuscript tracking number * If this is a JMIR submission, please provide the manuscript tracking number under "other" (The ms tracking number can be found in the submission acknowledgement email, or when you login as author in JMIR. If the paper is already published in JMIR, then the ms tracking number is the four-digit number at the end of the DOI, to be found at the 1a-i) Identify the mode of delivery in the title Identify the mode of delivery. Preferably use "web-based" and/or "mobile" and/or "electronic game" in the title. Avoid ambiguous terms like "online", "virtual", "interactive". Use "Internet-based" only if Intervention includes non-web-based Internet components (e.g. email), use "computer-based" or "electronic" only if o ine products are used. Use "virtual" only in the context of "virtual reality" (3-D worlds). Use "online" only in the context of "online support groups". Complement or substitute product names with broader terms for the class of products (such as "mobile" or "smart phone" instead of "iphone"), especially if the application runs on different platforms.
Does your paper address subitem 1a-i? * Copy and paste relevant sections from manuscript title (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "Showing 5-minute movies via a smartphone application to educate stroke survivors and their caregivers in an LMIC country does not increase adherence but reduces mortality after stroke -Results of Movies4Stroke; A Randomized Controlled Trial" subitem not at all important 1 2 3 4 5 essential subitem not at all important 1 2 3 4 5 essential 1a-ii) Non-web-based components or important co-interventions in title Mention non-web-based components or important co-interventions in title, if any (e.g., "with telephone support").
Does your paper address subitem 1a-ii?
Copy and paste relevant sections from manuscript title (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study We provided a Stroke Helpline number to our study participants where they could call at any time of day (24x7) to register their query (except any emergency) to a fully trained health care professional who would revert back to them within 24 hours after consulting a stroke specialist. This helpline number was available for participants in both the groups.
1a-iii) Primary condition or target group in the title Mention primary condition or target group in the title, if any (e.g., "for children with Type I Diabetes") Example: A Web-based and Mobile Intervention with Telephone Support for Children with Type I Diabetes: Randomized Controlled Trial Does your paper address subitem 1a-iii? * Copy and paste relevant sections from manuscript title (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "to educate stroke survivors and their caregivers in an LMIC country" 1b) ABSTRACT: Structured summary of trial design, methods, results, and conclusions NPT extension: Description of experimental treatment, comparator, care providers, centers, and blinding status.
subitem not at all important Does your paper address subitem 1b-i? * Copy and paste relevant sections from the manuscript abstract (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "The video-based education intervention group had health education delivered through short videos that focused on a skill relevant to stroke that was shown to the participants and their caregivers at the time of admission, before discharge, at follow-up at rst and third month post discharge. The control group had standardized care including pre-discharge education and counseling according to de ned protocols of the center" subitem not at all important 1 2 3 4 5 essential Does your paper address subitem 1b-ii?
Copy and paste relevant sections from the manuscript abstract (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study This information is not directly relevant to be addressed in the abstract section as part of the main ndings, otherwise the abstract will be too lengthy. Our intervention was a smart phone application which was installed in the cell phones of the study participants by a trained research o cer, simultaneously, the entire applicability and the usage of the app was also demonstrated by the same person. Moreover, the study participants were demonstrated on how to use the application at home without any di culty.
1b-iii) Open vs. closed, web-based (self-assessment) vs. face-toface assessments in the METHODS section of the ABSTRACT Mention how participants were recruited (online vs. o ine), e.g., from an open access website or from a clinic or a closed online user group (closed usergroup trial), and clarify if this was a purely web-based trial, or there were face-to-face components (as part of the intervention or for assessment). Clearly say if outcomes were self-assessed through questionnaires (as common in web-based trials Copy and paste relevant sections from the manuscript abstract (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "A randomized controlled, outcome assessor blinded, parallel group, single center superiority trial in which participants (stroke survivor -caregiver dyads) with rst ever stroke (both ischemic and hemorrhagic) were randomized within 48 hours of their stroke to either the video-based education intervention group or the control group" "A stroke survivor was de ned as any adult aged 18 years of age or older, having experienced rst ever stroke (ischemic or hemorrhagic) within the past 6 weeks, with mild to moderate disability, moreover, stroke is clinically stable and the stroke survivor is returning to the community for chronic care. Caregiver was de ned as an adult aged 18 years of age or older who is present 24 hours a day with the stroke survivor and provides the overall day-to-day care of the stroke survivor. All participants enrolled in this video education intervention group and control group were followed for 12 months post discharge for the assessment of outcomes in the outpatient stroke clinics" 1b-iv) RESULTS section in abstract must contain use data Report number of participants enrolled/assessed in each group, the use/uptake of the intervention (e.g., attrition/adherence metrics, use over time, number of logins etc.), in addition to primary/secondary outcomes. Copy and paste relevant sections from the manuscript abstract (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "Three hundred and ten stroke survivors and their caregiver dyads (participant dyads) were recruited over a duration of six months. We screened 400 participant dyads to assess eligibility, of these 50 were not eligible and 40 participant dyads refused to participate in the study. One hundred and fty-ve participant dyads were randomized in the intervention group and control group respectively" 1b-v) CONCLUSIONS/DISCUSSION in abstract for negative trials Conclusions/Discussions in abstract for negative trials: Discuss the primary outcome -if the trial is negative (primary outcome not changed), and the intervention was not used, discuss whether negative results are attributable to lack of uptake and discuss reasons. (Note: Only report in the abstract what the main paper is reporting. If this information is missing from the main body of text, consider adding it) Does your paper address subitem 1b-v?
Copy and paste relevant sections from the manuscript abstract (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "The Movies4Stroke trial failed to achieve its primary speci ed outcome. Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "Despite these challenges, there is potential to leverage mobile technology to improve stroke outcomes. Pakistan has widespread mobile connectivity, with a cellular density of 77%. These infrastructure enablers create distinct opportunities for mHealth. Our rationale was to leverage IT based mHealth to provide a solution and knowledge and direct skills to the survivor and caregiver where provision of chronic continuous care is rudimentary" "We rationalized that the absence of trained personnel in the health community could be mitigated by actually providing high quality repetitive training using audio visual aids which served as a checklist for competency and survival skills to the stroke and caregiver dyad" Does your paper address CONSORT subitem 2b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "In this study, we aim to evaluate the effectiveness and safety of a locally designed, 5 minute movies rolled out in order of relevance, thematically delivered three months long program to deliver post-stroke education to stroke survivor and caregiver dyads returning to the community. We rationalized that the absence of trained personnel in the health community could be mitigated by actually providing high quality repetitive training using audio visual aids which served as a checklist for competency and survival skills to the stroke and caregiver dyad" 3b) Important changes to methods after trial commencement (such as eligibility criteria), with reasons subitem not at all important 1 2 3 4 5 essential Does your paper address CONSORT subitem 3a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "A randomized control, outcome assessor blinded, parallel group, single center superiority trial was conducted to assess the e cacy of mobile phone video-based IT intervention in controlling three major risk factors (blood pressure, blood glucose and cholesterol) among adult stroke survivors" Does your paper address CONSORT subitem 3b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Not applicable. No important changes as such were made to the trial methodology after it's commenced.

3b-i) Bug xes, Downtimes, Content Changes
Bug xes, Downtimes, Content Changes: ehealth systems are often dynamic systems. A description of changes to methods therefore also includes important changes made on the intervention or comparator during the trial (e.g., major bug xes or changes in the functionality or content) (5-iii) and other "unexpected events" that may have in uenced study design such as staff changes, system failures/downtimes, etc. [2].
Does your paper address subitem 3b-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Not Applicable. There were minor bug xes or glitches identi ed during the pilot testing phases of our intervention (alpha, beta and gamma) which were resolved without any major change in the content. However, there was no major glitches or bug xing issues identi ed during this process.
Does your paper address CONSORT subitem 4a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "Eligibility Criteria: Does your paper address subitem 4a-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "Have a designated caregiver at home who is responsible for appointments, followup, overall care and are smartphone literate, e.g., wife, daughters, daughter-in-law, husband, etc" 4a-ii) Open vs. closed, web-based vs. face-to-face assessments: Open vs. closed, web-based vs. face-to-face assessments: Mention how participants were recruited (online vs. o ine), e.g., from an open access website or from a clinic, and clarify if this was a purely web-based trial, or there were face-to-face components (as part of the intervention or for assessment), i.e., to what degree got the study team to know the participant. In online-only trials, clarify if participants were quasi-anonymous and whether having multiple identities was possible or whether technical or logistical measures (e.g., cookies, email con rmation, phone calls) were used to detect/prevent these.
subitem not at all important 1 2 3 4 5 essential 4b) Settings and locations where the data were collected Does your paper address subitem 4a-ii? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "Informed consent was taken from eligible participants who volunteered to be part of this study, after a thorough explanation was provided to them regarding its nature and the scheduled follow-up visits. A detailed face to face interview of stroke survivors and their caregivers was conducted to gather data on socio-demographic and medical history. A baseline clinical and functional assessment was done after which they were randomly assigned into the intervention or the control group" 4a-iii) Information giving during recruitment Information given during recruitment. Specify how participants were briefed for recruitment and in the informed consent procedures (e.g., publish the informed consent documentation as appendix, see also item X26), as this information may have an effect on user self-selection, user expectation and may also bias results.
Does your paper address subitem 4a-iii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "Informed consent was taken from eligible participants who volunteered to be part of this study, after a thorough explanation was provided to them regarding its nature and the scheduled follow-up visits. A detailed face to face interview of stroke survivors and their caregivers was conducted to gather data on socio-demographic and medical history. A baseline clinical and functional assessment was done after which they were randomly assigned into the intervention or the control group" subitem not at all important 1 2 3 4 5 essential subitem not at all important 1 2 3 4 5 essential Does your paper address CONSORT subitem 4b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "A purposive sample was selected from adult stroke survivors being admitted to Stroke Unit, Neurology Ward, Aga Khan University Hospital, Karachi after the assessment of the eligibility criteria and informed consent has been obtained" 4b-i) Report if outcomes were (self-)assessed through online questionnaires Clearly report if outcomes were (self-)assessed through online questionnaires (as common in webbased trials) or otherwise.
Does your paper address subitem 4b-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Not Applicable. There were no online surveys/questionnaires used in our trial.

4b-ii) Report how institutional a liations are displayed
Report how institutional a liations are displayed to potential participants [on ehealth media], as a liations with prestigious hospitals or universities may affect volunteer rates, use, and reactions with regards to an intervention.(Not a required item -describe only if this may bias results) 5) The interventions for each group with su cient details to allow replication, including how and when they were actually administered subitem not at all important 1 2 3 4 5 essential Does your paper address subitem 4b-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Not Applicable for our trial as such. We recruited all the participants from a single center (Aga Khan University Hospital) for this mHealth clinical trial and all the study participants were admitted to the same hospital with a diagnosis of acute stroke. Moreover, all the participants in the intervention group knew that this smart phone application is a property of AKUH.

5-i) Mention names, credential, a liations of the developers, sponsors, and owners
Mention names, credential, a liations of the developers, sponsors, and owners [6] (if authors/evaluators are owners or developer of the software, this needs to be declared in a "Con ict of interest" section or mentioned elsewhere in the manuscript).
Does your paper address subitem 5-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "Movies4Stroke application was developed by biomedical and software engineers of Aga Khan Development Network eHealth Resource Center (AKDN eHRC) in collaboration with stroke specialists, rehabilitation and swallowing experts and epidemiologists" subitem not at all important 1 2 3 4 5 essential subitem not at all important 1 2 3 4 5 essential 5-ii) Describe the history/development process Describe the history/development process of the application and previous formative evaluations (e.g., focus groups, usability testing), as these will have an impact on adoption/use rates and help with interpreting results.
Does your paper address subitem 5-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study " The intervention was rst pilot tested on study team members' android cell phone.
Any discrepancies and bugs were removed from the application. The intervention was then launched in the tablets, specially purchased for showing the movies to the stroke survivors and their caregivers in clinical ward settings. Memory chips were also purchased so that the Stroke Movie Application can be transferred in the participants' cell phone"

5-iii) Revisions and updating
Revisions and updating. Clearly mention the date and/or version number of the application/intervention (and comparator, if applicable) evaluated, or describe whether the intervention underwent major changes during the evaluation process, or whether the development and/or content was "frozen" during the trial. Describe dynamic components such as news feeds or changing content which may have an impact on the replicability of the intervention (for unexpected events see item 3b).
Does your paper address subitem 5-iii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study " The intervention was rst pilot tested on study team members' android cell phone.
Any discrepancies and bugs were removed from the application".
The intervention did not undergo signi cant changes after it was pilot tested nor the content of the application were changed.
subitem not at all important 1 2 3 4 5 essential subitem not at all important 1 2 3 4 5 essential 5-iv) Quality assurance methods Provide information on quality assurance methods to ensure accuracy and quality of information provided [1], if applicable.
Does your paper address subitem 5-iv?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "A study o cer who was not blinded to the intervention group took several measures to ensure compliance of the participants to the videos as mentioned in the protocol" 5-v) Ensure replicability by publishing the source code, and/or providing screenshots/screen-capture video, and/or providing owcharts of the algorithms used Ensure replicability by publishing the source code, and/or providing screenshots/screen-capture video, and/or providing owcharts of the algorithms used. Replicability (i.e., other researchers should in principle be able to replicate the study) is a hallmark of scienti c reporting.
Does your paper address subitem 5-v?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study There are two gures in the manuscript to address this point.

5-vi) Digital preservation
Digital preservation: Provide the URL of the application, but as the intervention is likely to change or disappear over the course of the years; also make sure the intervention is archived (Internet Archive, webcitation.org, and/or publishing the source code or screenshots/videos alongside the article). As pages behind login screens cannot be archived, consider creating demo pages which are accessible without login.
Does your paper address subitem 5-vi?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study " Figure 1: Movies4Stroke Collage" in the manuscript is addressing this point

5-vii) Access
Access: Describe how participants accessed the application, in what setting/context, if they had to pay (or were paid) or not, whether they had to be a member of speci c group. If known, describe how participants obtained "access to the platform and Internet" [1]. To ensure access for editors/reviewers/readers, consider to provide a "backdoor" login account or demo mode for reviewers/readers to explore the application (also important for archiving purposes, see vi).
subitem not at all important 1 2 3 4 5 essential Does your paper address subitem 5-vii? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "The intervention was then launched in the tablets, specially purchased for showing the movies to the stroke survivors and their caregivers in clinical ward settings. Memory chips were also purchased so that the Stroke Movie Application can be transferred in the participants' cell phone" "In addition to the usual care, the intervention group at the time of admission received the introductory teaching session with installation of the application and the rst set of 5 minute videos on various stroke related topics as described below" subitem not at all important 1 2 3 4 5 essential Does your paper address subitem 5-viii? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "In addition to the usual care, the intervention group at the time of admission received the introductory teaching session with installation of the application and the rst set of 5 minute videos on various stroke related topics as described below.
In the rst session, different skills such as swallowing exercises, different rehabilitation exercises and naso-gastric tube feeding were taught to the care-givers.
The second session was delivered at the time of discharge which included videos on emergency preparedness, such as cardiopulmonary resuscitation, seizures, heart attack, hypoglycemia, simultaneously having discussion and answering any queries the participants had, after watching each set of videos. The third session was delivered at rst month follow-up post discharge and included videos on frequently used medications by stroke survivors, such as anticoagulants, anti-hypertensive and lipid-lowering drugs. Fourth session was delivered at third month follow-up post discharge and included videos on secondary stroke prevention (recurrent attack)exercise, physical activity, recognition of depression, diet modi cation and accurate measurement of blood pressure and blood sugar levels"

5-ix) Describe use parameters
Describe use parameters (e.g., intended "doses" and optimal timing for use). Clarify what instructions or recommendations were given to the user, e.g., regarding timing, frequency, heaviness of use, if any, or was the intervention used ad libitum.
subitem not at all important 1 2 3 4 5 essential Does your paper address subitem 5-ix?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study As discussed in the manuscript, in total, four sessions of the intervention (Movies4Stroke) were delivered to the participant dyads (stroke survivors and their caregivers) during the progress of this study. One at the time of admission, one at discharge, one at rst month and the last at three months after discharge to the participants in the intervention group.

5-x) Clarify the level of human involvement
Clarify the level of human involvement (care providers or health professionals, also technical assistance) in the e-intervention or as co-intervention (detail number and expertise of professionals involved, if any, as well as "type of assistance offered, the timing and frequency of the support, how it is initiated, and the medium by which the assistance is delivered". It may be necessary to distinguish between the level of human involvement required for the trial, and the level of human involvement required for a routine application outside of a RCT setting (discuss under item 21 -generalizability).
Does your paper address subitem 5-x?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study The mobile based intervention (Movies4Stroke)  Details of all these mentioned in the protocol.
subitem not at all important 1 2 3 4 5 essential subitem not at all important 1 2 3 4 5 essential 5-xi) Report any prompts/reminders used Report any prompts/reminders used: Clarify if there were prompts (letters, emails, phone calls, SMS) to use the application, what triggered them, frequency etc. It may be necessary to distinguish between the level of prompts/reminders required for the trial, and the level of prompts/reminders for a routine application outside of a RCT setting (discuss under item 21 -generalizability).
Does your paper address subitem 5-xi? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "Participants in the intervention group were sent twice weekly messages as a reminder to watch the movies at home. These messages were sent through an online programmed open access software entitled "Frontline" by a trained I.T professional"

5-xii) Describe any co-interventions (incl. training/support)
Describe any co-interventions (incl. training/support): Clearly state any interventions that are provided in addition to the targeted eHealth intervention, as ehealth intervention may not be designed as standalone intervention. This includes training sessions and support [1]. It may be necessary to distinguish between the level of training required for the trial, and the level of training for a routine application outside of a RCT setting (discuss under item 21 -generalizability. Does your paper address subitem 5-xii? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "Secondly, in this study, in order to maintain long-term follow up, the control group also had access to a 24/7 helpline, and interaction with healthcare personnel who assisted and resolved queries may have improved adherence in this group as well.
The presence of a centralized helpline has shown to help address queries and also help patients cope with di cult situations" 6a) Completely de ned pre-speci ed primary and secondary outcome measures, including how and when they were assessed subitem not at all important 1 2 3 4 5 essential Does your paper address CONSORT subitem 6a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "The primary outcome was; Control of three major risk factors, blood pressure, blood sugar and lipids, measured via standardized methods in the central laboratory were ascertained at baseline, 6th and 12th month post-discharge. All the three risk factors were assessed as the proportion of participants achieving the control of blood pressure (<125/85 mmHg), blood sugar (HbA1C <7%) and blood cholesterol (LDL <100 mg/dl) respectively.
The secondary were; Stroke related mortality among stroke survivors was ascertained at 12th month post-discharge, Stroke disability and neurological de cits among stroke survivors was ascertained at baseline, 6th and 12th month postdischarge" 6a-i) Online questionnaires: describe if they were validated for online use and apply CHERRIES items to describe how the questionnaires were designed/deployed If outcomes were obtained through online questionnaires, describe if they were validated for online use and apply CHERRIES items to describe how the questionnaires were designed/deployed [9].
Does your paper address subitem 6a-i? 6b) Any changes to trial outcomes after the trial commenced, with reasons 6a-ii) Describe whether and how "use" (including intensity of use/dosage) was de ned/measured/monitored Describe whether and how "use" (including intensity of use/dosage) was de ned/measured/monitored (logins, log le analysis, etc.). Use/adoption metrics are important process outcomes that should be reported in any ehealth trial.
Does your paper address subitem 6a-ii?
Copy and paste relevant sections from manuscript text The number of times a particular movie was seen in a home environment by the participant dyads was recorded in the application and is currently being analysed and will be reported in the subsequent manuscript related to this mHealth trial.
6a-iii) Describe whether, how, and when qualitative feedback from participants was obtained Describe whether, how, and when qualitative feedback from participants was obtained (e.g., through emails, feedback forms, interviews, focus groups).

Does your paper address subitem 6a-iii?
Copy and paste relevant sections from manuscript text The feedback related to the application (Movies4Stroke) was obtained through feedback forms and informal interviews. They have been analysed and will be reported in the subsequent manuscript as part of secondary outcomes. 7a) How sample size was determined NPT: When applicable, details of whether and how the clustering by care provides or centers was addressed subitem not at all important 1 2 3 4 5 essential 7b) When applicable, explanation of any interim analyses and stopping guidelines Does your paper address CONSORT subitem 6b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Not Applicable 7a-i) Describe whether and how expected attrition was taken into account when calculating the sample size Describe whether and how expected attrition was taken into account when calculating the sample size.
Does your paper address subitem 7a-i?
Copy and paste relevant sections from manuscript title (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Sample size calculation has been explicitly stated in the protocol keeping in mind the anticipated attrition rate.
Does your paper address CONSORT subitem 7b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Not Applicable 8a) Method used to generate the random allocation sequence NPT: When applicable, how care providers were allocated to each trial group 8b) Type of randomisation; details of any restriction (such as blocking and block size) 9) Mechanism used to implement the random allocation sequence (such as sequentially numbered containers), describing any steps taken to conceal the sequence until interventions were assigned Does your paper address CONSORT subitem 8a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "Stroke survivors and their caregivers (dyad) were assigned to either the intervention group or the usual care group in a parallel fashion in a ratio of 1:1. A computer generated randomization list was used to randomize subjects to the control group or the intervention group. The randomization center was at a secure computer in the Clinical Trials Unit and the randomization list was generated by CTU staff not involved in recruitment, outcome ascertainment or any aspect of the study " Does your paper address CONSORT subitem 8b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "Block randomization technique with a xed block size of ten was used" 10) Who generated the random allocation sequence, who enrolled participants, and who assigned participants to interventions 11a) If done, who was blinded after assignment to interventions (for example, participants, care providers, those assessing outcomes) and how NPT: Whether or not administering co-interventions were blinded to group assignment Does your paper address CONSORT subitem 9? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "Randomization list was centralized and thus not predictable. No one from the research team had any access to randomization list, randomization envelopes, block size or code. It was made sure that envelopes were sealed, opaque and it was impossible to view the sequence even if held against bright sunlight. Randomization list and opaque envelopes containing the randomization sequence were always kept inside the premises of Clinical Trials Unit (CTU) under lock and key" Does your paper address CONSORT subitem 10? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "The randomization center was at a secure computer in the Clinical Trials Unit and the randomization list was generated by CTU staff not involved in recruitment, outcome ascertainment or any aspect of the study" "A baseline clinical and functional assessment was done after which they were randomly assigned into the intervention or the control group by a trained research o cer who was not blinded to the assignment of the intervention" subitem not at all important 1 2 3 4 5 essential subitem not at all important 1 2 3 4 5 essential 11b) If relevant, description of the similarity of interventions (this item is usually not relevant for ehealth trials as it refers to similarity of a placebo or sham intervention to a active medication/intervention) 11a-i) Specify who was blinded, and who wasn't Specify who was blinded, and who wasn't. Usually, in web-based trials it is not possible to blind the participants [1, 3] (this should be clearly acknowledged), but it may be possible to blind outcome assessors, those doing data analysis or those administering co-interventions (if any).
Does your paper address subitem 11a-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study The outcome assessor was blinded and was unaware of the assignment group.
11a-ii) Discuss e.g., whether participants knew which intervention was the "intervention of interest" and which one was the "comparator" Informed consent procedures (4a-ii) can create biases and certain expectations -discuss e.g., whether participants knew which intervention was the "intervention of interest" and which one was the "comparator".
Does your paper address subitem 11a-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Yes the study participants knew that whether they were receiving Movies4Stroke or not because of the nature of the intervention.
12a) Statistical methods used to compare groups for primary and secondary outcomes NPT: When applicable, details of whether and how the clustering by care providers or centers was addressed subitem not at all important 1 2 3 4 5 essential 12b) Methods for additional analyses, such as subgroup analyses and adjusted analyses Does your paper address CONSORT subitem 11b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Not Applicable Does your paper address CONSORT subitem 12a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Statistical plan of analysis mentioned explicitly in the protocol.
12a-i) Imputation techniques to deal with attrition / missing values Imputation techniques to deal with attrition / missing values: Not all participants will use the intervention/comparator as intended and attrition is typically high in ehealth trials. Specify how participants who did not use the application or dropped out from the trial were treated in the statistical analysis (a complete case analysis is strongly discouraged, and simple imputation techniques such as LOCF may also be problematic [4]).
Does your paper address subitem 12a-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Does your paper address CONSORT subitem 12b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Statistical plan of analysis mentioned explicitly in the protocol.

X26-i) Comment on ethics committee approval
Does your paper address subitem X26-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study

RESULTS
Does your paper address subitem X26-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "A written informed consent, in both English and Urdu, was obtained from all the study participants at the time of recruitment. The con dentiality and privacy of the participants was maintained by de-identi cation of the subject information. Only research staff was authorized entry into the hospital system on the computers that were used for data storage. All source documents were maintained in locked les in locked room. Fingerprint encryption was added to all sensitive data e.g. mobile numbers, app logs and error logs etc. The staff provided to this level of data access was very limited"

X26-iii) Safety and security procedures
Safety and security procedures, incl. privacy considerations, and any steps taken to reduce the likelihood or detection of harm (e.g., education and training, availability of a hotline) Does your paper address subitem X26-iii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "Only research staff was authorized entry into the hospital system on the computers that were used for data storage. All source documents were maintained in locked les in locked room. Fingerprint encryption was added to all sensitive data e.g. mobile numbers, app logs and error logs etc " 13a) For each group, the numbers of participants who were randomly assigned, received intended treatment, and were analysed for the primary outcome NPT: The number of care providers or centers performing the intervention in each group and the number of patients treated by each care provider in each center 13b) For each group, losses and exclusions after randomisation, together with reasons Does your paper address CONSORT subitem 13a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "Three hundred and ten stroke survivors and their caregiver dyads, therefore 620 individuals (participant dyads) were recruited over a duration of six months. Since this clinical trial had a xed block design, one hundred and fty-ve participant dyads were randomized in the intervention group and control group respectively (310 in each group). We screened 400 participant dyads to assess eligibility, of these 50 were not eligible and 40 participant dyads refused to participate in the study (30% were excluded)" subitem not at all important 1 2 3 4 5 essential 14a) Dates de ning the periods of recruitment and follow-up Does your paper address CONSORT subitem 13b? (NOTE: Preferably, this is shown in a CONSORT ow diagram) * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "The reasons for exclusions were 25 had MRS > 4, 15 had travel plans , 10 were not Karachi residents The reasons for refusal were mainly; lack of ability to return for follow-up, and lack of personal interest of the stroke survivor or caregiver to participate in the study. We were able to complete information on 141 participant dyads in the intervention group and 137 in the control group at the end of one-year post-discharge follow-up. From the intervention group, eleven participant dyads were lost to follow-up at one year post-discharge and three stroke survivors died due to in hospital mortality (before being discharged) due to inpatient complications from the index stroke, as compared to fteen participant dyads who were lost to follow-up and three died due to in hospital mortality in the control group. There was one protocol violation in the control group which was excluded from the nal analysis" 13b-i) Attrition diagram Strongly recommended: An attrition diagram (e.g., proportion of participants still logging in or using the intervention/comparator in each group plotted over time, similar to a survival curve) or other gures or tables demonstrating usage/dose/engagement.

Does your paper address subitem 13b-i?
Copy and paste relevant sections from the manuscript or cite the gure number if applicable (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Please refer to Figure 3 in the manuscript subitem not at all important 1 2 3 4 5 essential 14b) Why the trial ended or was stopped (early) Does your paper address CONSORT subitem 14a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study This point has been addressed in the heading of participants timeline "After recruiting stroke survivors along with their primary caregivers from the Stroke unit at AKUH, the participant dyads were not expected for any additional visits for the study purpose other than the scheduled ve follow-up visits at the stroke clinic. Our study started enrolling participants from January 19th, 2015 and last participant was recruited on May 15th, 2015. The last follow-up was completed on June 29th, 2016" 14a-i) Indicate if critical "secular events" fell into the study period Indicate if critical "secular events" fell into the study period, e.g., signi cant changes in Internet resources available or "changes in computer hardware or Internet delivery resources" Does your paper address subitem 14a-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Not Applicable Does your paper address CONSORT subitem 14b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Not Applicable 15) A ) For each group, number of participants (denominator) included in each analysis and whether the analysis was by original assigned groups Does your paper address CONSORT subitem 15? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Please refer to Table 1 in the manuscript.

15-i) Report demographics associated with digital divide issues
In ehealth trials it is particularly important to report demographics associated with digital divide issues, such as age, education, gender, social-economic status, computer/Internet/ehealth literacy of the participants, if known.
Does your paper address subitem 15-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Please refer to Table 1 in the manuscript.
subitem not at all important 1 2 3 4 5 essential subitem not at all important 1 2 3 4 5 essential 16-i) Report multiple "denominators" and provide de nitions Report multiple "denominators" and provide de nitions: Report N's (and effect sizes) "across a range of study participation [and use] thresholds" [1], e.g., N exposed, N consented, N used more than x times, N used more than y weeks, N participants "used" the intervention/comparator at speci c pre-de ned time points of interest (in absolute and relative numbers per group). Always clearly de ne "use" of the intervention.
Does your paper address subitem 16-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study This concept (Intention To Treat principle) has been used to report results across all the tables within the manuscript.
Moreover, the concept of using multiple denominators with absolute numbers and percentages have also been reported across all the tables within the manuscript.

16-ii) Primary analysis should be intent-to-treat
Primary analysis should be intent-to-treat, secondary analyses could include comparing only "users", with the appropriate caveats that this is no longer a randomized sample (see 18-i).
Does your paper address subitem 16-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Please refer to Tables 3 to 10 for reporting of primary analysis through Intention To Treat principle.
17a) For each primary and secondary outcome, results for each group, and the estimated effect size and its precision (such as 95% con dence interval) subitem not at all important 1 2 3 4 5 essential 17b) For binary outcomes, presentation of both absolute and relative effect sizes is recommended Does your paper address CONSORT subitem 17a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Please refer to Tables 3 to 10 for reporting of primary and secondary outcomes.
17a-i) Presentation of process outcomes such as metrics of use and intensity of use In addition to primary/secondary (clinical) outcomes, the presentation of process outcomes such as metrics of use and intensity of use (dose, exposure) and their operational de nitions is critical. This does not only refer to metrics of attrition (13-b) (often a binary variable), but also to more continuous exposure metrics such as "average session length". These must be accompanied by a technical description how a metric like a "session" is de ned (e.g., timeout after idle time) [1] (report under item 6a).
Does your paper address subitem 17a-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Not Applicable.
Does your paper address CONSORT subitem 17b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Please refer to Tables 3 to 10 for reporting of primary and secondary outcomes. Does your paper address CONSORT subitem 18? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Please refer to Appendix 3

18-i) Subgroup analysis of comparing only users
A subgroup analysis of comparing only users is not uncommon in ehealth trials, but if done, it must be stressed that this is a self-selected sample and no longer an unbiased sample from a randomized trial (see 16-iii).
Does your paper address subitem 18-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study This sub-group analysis has been done and will be reported in the subsequent manuscript of Movies4Stroke.
Does your paper address CONSORT subitem 19? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Does your paper address subitem 19-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study No event as such was reported during the progress of this trial.

19-ii) Include qualitative feedback from participants or observations from staff/researchers
Include qualitative feedback from participants or observations from staff/researchers, if available, on strengths and shortcomings of the application, especially if they point to unintended/unexpected effects or uses. This includes (if available) reasons for why people did or did not use the application as intended by the developers.
Does your paper address subitem 19-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Not assessed in this manuscript but will surely be reported in the subsequent manuscript.
22) Interpretation consistent with results, balancing bene ts and harms, and considering other relevant evidence NPT: In addition, take into account the choice of the comparator, lack of or partial blinding, and unequal expertise of care providers or centers in each group subitem not at all important 1 2 3 4 5 essential 22-i) Restate study questions and summarize the answers suggested by the data, starting with primary outcomes and process outcomes (use) Restate study questions and summarize the answers suggested by the data, starting with primary outcomes and process outcomes (use).
Does your paper address subitem 22-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "Movies for stroke is a randomized controlled mHealth trial evaluating the effectiveness and safety of a phone-based intervention which showed thematically designed videos to assist the stroke survivor and caregiver dyad to get the knowledge, skills and con dence needed to improve post-stroke medication adherence, risk factor control, survival and functional outcomes. The rationale of this trial was to provide repetitive high-quality survival and training to stroke survivor and caregiver dyads returning to a low-middle income community where rehabilitation and chronic care systems are underdeveloped. The mode of videobased IT intervention along with competency and understanding checks and the ability to repeat and see a video was used to assist understanding in a literacy challenged population which, however, had access to a cell phone. None of the trial participants were excluded due to lack of cell phone. This mHealth trial failed to reach its primary outcome measure of control of hypertension, LDL cholesterol and HbA1C, however the pre-speci ed secondary variables of improved functional outcomes and reduced mortality were improved in the intervention group in this study with highly signi cant results on mortality due to stroke related complications" Does your paper address subitem 22-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "Our results demonstrate the key importance of health theory in designing these complex health interventions for replicability and for informing further interventions.
Interventions that target compliance must have repetitive reminders for nonintentional adherence and interventions that target knowledge and skills transfer must have the capacity to repeat and bolster con dence, as well as provide the user the opportunity to model themselves from the materials taught, despite lack of literacy skills to be safe. Complex interventions targeting these settings need to have a design theory in place to deliver both these aspects to be effective"

20-i) Typical limitations in ehealth trials
Typical limitations in ehealth trials: Participants in ehealth trials are rarely blinded. Ehealth trials often look at a multiplicity of outcomes, increasing risk for a Type I error. Discuss biases due to non-use of the intervention/usability issues, biases through informed consent procedures, unexpected events. 21) Generalisability (external validity, applicability) of the trial ndings NPT: External validity of the trial ndings according to the intervention, comparators, patients, and care providers or centers involved in the trial subitem not at all important 1 2 3 4 5 essential Does your paper address subitem 20-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "The major limitation of our clinical trial is that it is a single center study, chosen because of the fact that this site provided a standard of care that is algorithmic and replicable, thus results generated can be attributed to the effect of intervention. In this study, we reported its e cacy, but the performance and potential effect size in different sites may be variable and may potentially be more effective, given the usual care standards in even more resource strapped comparative health systems for e.g. the government sector and thus external validity is limited. Furthermore, those with more severe stroke or better health access due to socio economic status are more likely to visit this health system and are more likely to volunteer to participate in an educational training intervention, thus limiting direct external validity. Another signi cant limitation is of contamination bias in an educational intervention. Care was taken to avoid contamination of the non-intervention group with the intervention. To ensure this, videos were shown in a separate room, and not at the bedside. Given the fact that families do share information, contamination was possible, however most stroke survivors were on different schedules for follow-up visits, rehabilitation times etc. and so we expected less contamination than in areas where a lot of time is spent together by families. Obviously, it is an inherent limitation of an educational intervention that blinding of participants isn't possible"

21-i) Generalizability to other populations
Generalizability to other populations: In particular, discuss generalizability to a general Internet population, outside of a RCT setting, and general patient population, including applicability of the study results for other organizations subitem not at all important 1 2 3 4 5 essential Does your paper address subitem 21-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "The major limitation of our clinical trial is that it is a single center study, chosen because of the fact that this site provided a standard of care that is algorithmic and replicable, thus results generated can be attributed to the effect of intervention. In this study, we reported its e cacy, but the performance and potential effect size in different sites may be variable and may potentially be more effective, given the usual care standards in even more resource strapped comparative health systems for e.g.
the government sector and thus external validity is limited. Furthermore, those with more severe stroke or better health access due to socio economic status are more likely to visit this health system and are more likely to volunteer to participate in an educational training intervention, thus limiting direct external validity. We would de nitely include non-response analysis in futures studies to further identify characteristics of those most likely to adopt the intervention. " 21-ii) Discuss if there were elements in the RCT that would be different in a routine application setting Discuss if there were elements in the RCT that would be different in a routine application setting (e.g., prompts/reminders, more human involvement, training sessions or other co-interventions) and what impact the omission of these elements could have on use, adoption, or outcomes if the intervention is applied outside of a RCT setting.

OTHER INFORMATION
23) Registration number and name of trial registry 24) Where the full trial protocol can be accessed, if available Does your paper address subitem 21-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "There were trained research o cers to ensure compliance of the intervention group participants at each video delivery, moreover, constant SMS reminders were sent to the study participants in the intervention group (as a measure of reinforcement) to watch these thematic movies in a relaxed home environment and they were also reminded about their scheduled follow-up visits" "This intervention in a study setting required human resources in terms of a study o cer, and IT back up , development required human resource, deployment required at least three staff in a study setting. In order to predict feasibility, we need to further analyse cost effectiveness and realistic compliance in a clinical setting with the current patient volumes, this limits directly recommending applicability. This study has collected data on cost effectiveness which is under analysis at this time" Does your paper address CONSORT subitem 23? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Clinicaltrials.gov NCT02202330 25) Sources of funding and other support (such as supply of drugs), role of funders X27) Con icts of Interest (not a CONSORT item) subitem not at all important 1 2 3 4 5 essential Does your paper address CONSORT subitem 24? * Cite a Multimedia Appendix, other reference, or copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study https://www.ncbi.nlm.nih.gov/pubmed/26818913 Does your paper address CONSORT subitem 25? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. The content is solely the responsibility of the authors and does not necessarily represent the o cial views of the Fogarty International Center, National Institute of Neurologic Disorders and Stroke (NIH) and University Research Council, Aga Khan University (funders of this project)" X27-i) State the relation of the study team towards the system being evaluated In addition to the usual declaration of interests ( nancial or otherwise), also state the relation of the study team towards the system being evaluated, i.e., state if the authors/evaluators are distinct from or identical with the developers/sponsors of the intervention. STOP -Save this form as PDF before you click submit To generate a record that you lled in this form, we recommend to generate a PDF of this page (on a Mac, simply select "print" and then select "print as PDF") before you submit it.
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