Analysis of the Implementation, User Perspectives, and Feedback From a Mobile Health Intervention for Individuals Living With Hypertension (DREAM-GLOBAL): Mixed Methods Study

Background DREAM-GLOBAL (Diagnosing hypertension—Engaging Action and Management in Getting Lower Blood Pressure in Indigenous and low- and middle-income countries) studied a SMS text messaging–based system for blood pressure measurement and hypertension management in Canadian Aboriginal and Tanzanian communities. The use of SMS text messages is an emerging point of interest in global health care initiatives because of their scalability, customizability, transferability, and cost-effectiveness. Objective The study aim was to assess the effect on the difference in blood pressure reduction of active hypertension management messages or passive health behavior messages. The system was designed to be implemented in remote areas with wireless availability. This study described the implementation and evaluation of technical components, including quantitative data from the transmission of blood pressure measurements and qualitative data collected on the operational aspects of the system from participants, health care providers, and community leadership. Methods The study was implemented in six remote Indigenous Canadian and two rural Tanzanian communities. Blood pressure readings were taken by a community health worker and transmitted to a mobile phone via Bluetooth, then by wireless to a programmed central server. From the server, the readings were sent to the participant’s own phone as well. Participants also received biweekly tailored SMS text messages on their phones. Quantitative data on blood pressure reading transmissions were collected from the study central server. Qualitative data were collected by surveys, focus groups, and key informant interviews of participants, health care providers, and health leadership. Results In Canada, between February 2014 and February 2017, 2818 blood pressure readings from 243 patients were transmitted to the central server. In Tanzania, between October 2014 and August 2015, 1165 readings from 130 patients were transmitted to the central server. The use of Bluetooth technology enabled the secure, reliable transmission of information from participants to their health care provider. The timing and frequency were satisfactory to 137 of 187 (73.2%) of participants, supporting the process of sending weekly messages twice on Mondays and Thursdays at 11 am. A total of 97.0% (164/169) of the participants surveyed said they would recommend participation in the DREAM-GLOBAL program to a friend or relative with hypertension. Conclusions In remote communities, the DREAM-GLOBAL study helped local health care providers deliver a blood pressure management program that enabled patients and community workers to feel connected. The technical components of the study were implemented as planned, and patients felt supported in their management through the SMS text messaging and mobile health program. Technological issues were solved with troubleshooting. Overall, the technical aspects of this research program enhanced clinical care and study evaluation and were well received by participants, health care workers, and community leadership. Trial Registration Clinicaltrials.gov NCT02111226; https://clinicaltrials.gov/ct2/show/NCT02111226.

is becoming a point of interest due to its scalability and capacity for adaptation to various populations at low cost [6]. There are mixed outcomes from text messages but more studies are finding that they are acceptable to recipients and beneficial in the management of chronic Does your paper address CONSORT subitem 2b? * Yes. "This paper provides a technical review of the DREAM-GLOBAL intervention, discussing the development, implementation and feedback of the system based on responses from study participants, health care providers and community health workers. " The primary outcome of the study was the difference in systolic and diastolic blood pressure from the baseline period to the last two months of measurement between METHODS 3a) Description of trial design (such as parallel, factorial) including allocation ratio 3b) Important changes to methods after trial commencement (such as eligibility criteria), with reasons Does your paper address CONSORT subitem 3a? * Yes. "The DREAM-GLOBAL study randomized participants to either active or passive SMS messages and protocol has been previously published [8]" Does your paper address CONSORT subitem 3b? * No changes to methods. 3b-i) Bug fixes, Downtimes, Content Changes 4a) Eligibility criteria for participants Does your paper address subitem 3b-i? While changes in the technology were required and are part of the focus of this manuscript, they did not force a change in methodology for the Canadian arm of this study, but did for the Tanzanian arm, which has been published previously in the protocol paper.
Does your paper address CONSORT subitem 4a? * Yes. "Participants were community members age 18 or older with uncontrolled hypertension, on or off medications. They had to either have a mobile phone capable of receiving SMS text messages or be willing to carry and learn to use a basic flip phone for the study duration. They also had to have a current primary health care provider. " 4a-i) Computer / Internet literacy Does your paper address subitem 4a-i? This was not a major factor. "Participants were community members age 18 or older with uncontrolled hypertension, on or off medications. They had to either have a mobile phone capable of receiving SMS text messages or be willing to carry and learn to use a basic flip phone for the study duration.
They also had to have a current primary health care provider." 4a-ii) Open vs. closed, web-based vs. face-to-face assessments: Does your paper address subitem 4a-ii? * Yes, participants were recruited by another community member trained to enroll and consent participants. "CHWCommunity Health Worker) and Home and Community Care nurses, after a two-day training session, were able to recruit, consent, register participants, and take three BP readings according to guidelines with the automated oscillometric BP device for each participant [15]." 4b) Settings and locations where the data were collected 4a-iii) Information giving during recruitment Does your paper address subitem 4a-iii?
Yes. "Training to carry out the study was conducted in each community by study team members at planned education sessions. Training CHWCommunity Health Workers in the study procedures included information on using the Bluetooth-enabled blood pressure machines, enrolling patients into the program, teaching patients how to use their cellular device, and communicating with their patients. They were also provided with an instructional video on how to use the mobile app and BP device to take the BP readings and transmit them to the central server.
Ongoing support for the CHWCommunity Health Workers was offered in the form of regular follow-up visits by the research team and Does your paper address CONSORT subitem 4b? * Yes. "The study took place in six Canadian First Nations communities and two rural communities in Tanzania. " 4b-i) Report if outcomes were (self-)assessed through online questionnaires Does your paper address subitem 4b-i? * No, items were not assessed through online questionnaires. 4b-ii) Report how institutional affiliations are displayed Does your paper address subitem 4b-ii?
Yes, institution was displayed on the research ethics consent form as is required.
5) The interventions for each group with sufficient details to allow replication, including how and when they were actually administered 5-viii) Mode of delivery, features/functionalities/components of the intervention and comparator, and the theoretical framework Does your paper address subitem 5-viii? * This information was included in the protocol paper which is referenced in this manuscript. The following information was included: "DREAM-GLOBAL was designed to increase the capacity for affordable, evidence-based, guidelines-driven hypertension management interventions at the patient, provider, and community level. This study demonstrated that information could be transmitted with fidelity and was able to access and to reach participants in remote settings. It also confirmed that patients were willing and able to participate in the program [18]. Participants in the study were able to successfully use the technology. The use of Bluetooth technology enabled the secure, reliable, and widespread transmission of information from participant to their health care provider, including transmission of guideline-based SMS messages to participants. "

5-ix) Describe use parameters
Does your paper address subitem 5-ix?
Yes. "On the questionnaire, 168 of 187 participants responded that the messages were clear enough 90% felt that they made sense. For 137 or 187, tThe timing and frequency was satisfactory to 73% of participants, supporting the twice weekly messages on Mondays and Thursdays at 11 am. In response to a probe about privacy concerns about having their blood pressure readings and other health messages sent to their phones, 91 of 121 respondents (76%) felt that this was not a problem" 5-x) Clarify the level of human involvement Does your paper address subitem 5-x?
Yes. "The DREAM-GLOBAL system in Canada comprised a Bluetoothenabled blood pressure monitor (A&D UA-767PBT) and a BlackBerry Bold smartphone with the DREAM-GLOBAL mobile application installed. In Tanzania, an Android smartphone was used. Blood pressure readings from the UA-767PBT blood pressure monitor were transmitted via Bluetooth to the CHWCommunity Health Worker's smartphone, and from the smartphone to a secure central server in Canada. The central server was programmed to assess the BP readings as normal or high. The server was programmed to wait for up to three blood pressure readings for an individual patient over 5 minutes. The average of the three readings was then calculated by the central server and then transmitted to the patient's primary health care provider by fax and to the patient's own phone by SMS.
If the blood pressure was high, an SMS message was sent to the participant with advice to contact their health care provider over the coming 6a-ii) Describe whether and how "use" (including intensity of use/dosage) was defined/measured/monitored Does your paper address subitem 6a-ii?
Yes. Text messages were sent twice weekly. 6a-iii) Describe whether, how, and when qualitative feedback from participants was obtained Does your paper address subitem 6a-iii?
Yes. "To evaluate components of the technology and processes of this study, both qualitative and quantitative data was collected. Qualitative data was collected from research notes from key informant interviews and focus groups, including reflective discussion sessions with research and community teams. This focused on the design, the mechanisms, and 7a-i) Describe whether and how expected attrition was taken into account when calculating the sample size Does your paper address subitem 7a-i?
This information was part of the protocol paper which has already been published and is referenced in this manuscript. 7b) When applicable, explanation of any interim analyses and stopping guidelines 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) Does your paper address CONSORT subitem 7b? * No interim analyses, or stopping rules in this study.
Does your paper address CONSORT subitem 8a? * This information was included in the protocol paper which has already been published.
Does your paper address CONSORT subitem 8b? * Yes, this information has already been published in the protocol paper. 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 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 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) 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 Does your paper address CONSORT subitem 11b? * This information was included in the protocol paper. "The DREAM-GLOBAL study randomized participants to either active or passive SMS messages and protocol has been previously published [8]. " Does your paper address CONSORT subitem 12a? * This is mainly a qualitative analysis. The main results paper was a quantitative analysis with appropriate statistical analyses description. Participants were invited to do this feedback and provided additional consent to share their responses. "

X26-iii) Safety and security procedures
Does your paper address subitem X26-iii?
Yes. "Cellular safety information was outlined to the participants prior to the study including adherence to a ban on hand-held devices while driving.
Participants were advised not to share their phone with others if they did not want anyone to know about their participation in the study and also advised not to send important personal information (i.e., bank account or credit card number)." 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? * This information was included in the main outcome paper and the protocol paper and was referenced in this manuscript.
Does your paper address CONSORT subitem 13b? (NOTE: Preferably, this is shown in a CONSORT flow diagram) * This information was included in the main outcome paper and the protocol paper and was referenced in this manuscript. 15-i) Report demographics associated with digital divide issues Does your paper address subitem 15-i? * The participants in this study covered a wide variety of ages and remote population locations. "The details of how the communities were identified and assessed for research readiness have been previously described [9].
The population size of the individual First Nations communities ranged from 500 to 4000. The communities were self-governed; they oversaw their own health care, which was provided in part by provincial and 16-i) Report multiple "denominators" and provide definitions Does your paper address subitem 16-i? * This data is included, but covers the entire study group. The byrandomization data is published in the main outcomes manuscript.

16-ii) Primary analysis should be intent-to-treat
Does your paper address subitem 16-ii? This is included in the main outcomes analysis and the protocol paper which are referenced. The primary analysis was ITT.
Yes. "DREAM-GLOBAL was designed to increase the capacity for affordable, evidence-based, guidelines-driven hypertension management interventions at the patient, provider, and community level. This study demonstrated that information could be transmitted with fidelity and was able to access and to reach participants in remote settings. It also confirmed that patients were willing and able to participate in the program [18]. Participants in the study were able to successfully use the technology. The use of Bluetooth technology enabled the secure, reliable, and widespread transmission of information from participant to their health care provider, including transmission of guideline-based SMS messages to participants. " 22-ii) Highlight unanswered new questions, suggest future research