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Published on 04.06.19 in Vol 7, No 6 (2019): June

Preprints (earlier versions) of this paper are available at http://preprints.jmir.org/preprint/11677, first published Jul 25, 2018.

This paper is in the following e-collection/theme issue:

    Original Paper

    A Feasibility Trial of Power Up: Smartphone App to Support Patient Activation and Shared Decision Making for Mental Health in Young People

    1Evidence Based Practice Unit, University College London and the Anna Freud National Centre for Children and Families, London, United Kingdom

    2National Institute of Health Research MindTech MedTech Co-operative, Nottingham, United Kingdom

    3National Institute of Health Research Nottingham Biomedical Research Centre, Nottingham, United Kingdom

    4Division of Psychiatry and Applied Psychology, Institute of Mental Health, University of Nottingham, Nottingham, United Kingdom

    5Bioengineering Research Group, Faculty of Engineering, University of Nottingham, Nottingham, United Kingdom

    6Common Room Consulting Limited, London, United Kingdom

    Corresponding Author:

    Julian Edbrooke-Childs, PhD

    Evidence Based Practice Unit

    University College London and the Anna Freud National Centre for Children and Families

    Clinical, Educational and Health Psychology, Gower Street

    London, WC1E 6BT

    United Kingdom

    Phone: 44 (0) 20 7794 2313

    Email:


    ABSTRACT

    Background: Digital tools have the potential to support patient activation and shared decision making in the face of increasing levels of mental health problems in young people. There is a need for feasibility trials of digital interventions to determine the usage and acceptability of interventions. In addition, there is a need to determine the ability to recruit and retain research participants to plan rigorous effectiveness trials and, therefore, develop evidence-based recommendations for practice.

    Objective: This study aimed to determine the feasibility of undertaking a cluster randomized controlled trial to test the effectiveness of a smartphone app, Power Up, co-designed with young people to support patient activation and shared decision making for mental health.

    Methods: Overall, 270 young people were screened for participation and 52.5% (142/270) were recruited and completed baseline measures across 8 specialist child mental health services (n=62, mean age 14.66 (SD 1.99) year; 52% [32/62] female) and 2 mainstream secondary schools (n=80; mean age 16.88 [SD 0.68] years; 46% [37/80] female). Young people received Power Up in addition to management as usual or received management as usual only. Posttrial interviews were conducted with 11 young people from the intervention arms (specialist services n=6; schools n=5).

    Results: Usage data showed that there were an estimated 50 (out of 64) users of Power Up in the intervention arms. Findings from the interviews indicated that young people found Power Up to be acceptable. Young people reported (1) their motivation for use of Power Up, (2) the impact of use, and (3) barriers to use. Out of the 142 recruited participants, 45.0% (64/142) completed follow-up measures, and the approaches to increase retention agreed by the steering group are discussed.

    Conclusions: The findings of this study indicate that the app is acceptable, and it is feasible to examine the effectiveness of Power Up in a prospective cluster randomized controlled trial.

    Trial Registration: ClinicalTrials.gov NCT02552797; https://clinicaltrials.gov/ct2/show/NCT02552797 (Archived by WebCite at http://www.webcitation.org/6td6MINP0)

    JMIR Mhealth Uhealth 2019;7(6):e11677

    doi:10.2196/11677

    KEYWORDS



    Introduction

    Background

    A minority of the population (17%) will not experience mental health problems in their lifetime [1]. On the basis of the last prevalence study, 10% of children in the United Kingdom have a clinically diagnosable mental health problem, with one of the most prevalent being emotional problems including anxiety and depression, of whom 25% receive support from specialist mental health services [2]. Recent evidence suggests that levels of mental health difficulties in young people are increasing with, for example, 1 in 4 young women experiencing emotional problems [3].

    Around 25% to 40% of the population have little knowledge, skills, and confidence to manage their own health and health care (referred to as patient activation) [4]. Empowering patients to be actively involved in the management of their health care and involving them in shared decision making are emphasized in the Health and Social Care Act 2012 [5]. Evidence suggests this may have a range of benefits to health and care [6]; for example, a systematic review found that patients were more likely to adhere to treatment when it was in line with their preferences [7,8]. However, empowering patients to actively manage their health care is not widely practiced [9] and clinicians report being unclear about how to facilitate it [10]. A systematic review of observer-rated studies showed that clinicians rarely facilitate patient involvement and adjust care to patient preferences even less often [11].

    Young people want to be actively involved in making decisions about their health care and report feeling more in control of their care when they are included in decisions [12]. Parents also feel that their children should be involved in decisions about their care as it may increase their self-esteem and improve their overall welfare [12]. Furthermore, it is recognized under the United Nations Convention on the Rights of the Child that young people should be involved in all matters that affect them.

    Interventions in child mental health settings which include empowering patients to be actively involved have been shown to improve quality of life and satisfaction [13,14], and child and parent experiences of shared decision making have been shown to be associated with higher levels of symptom improvement [15]. Evidence of promise has also emerged from an evaluation of tools supporting young people’s mental health through preparing for discussions, mood tracking, and self-management [16]. Evidence from adult settings suggests that interventions targeting empowerment and patient activation may promote engagement with services and interventions [17]. Nonattendance of appointments in child mental health services is an estimated 15% to 28% [18-23]. Noncollaborative decision making is a key predictor of nonattendance [24]. Introducing resources that promote better accessibility to and integration of care, and that which correspondingly make clinicians’ time more efficient, would be invaluable to guarantee that services such as specialist child mental health services can continue to provide good quality service to as many people as possible.

    Despite these benefits, young people are presented with a lack of opportunities for reflection and involvement in the decisions that affect them and can often feel unskilled or unsupported in these situations. This is a barrier to their involvement. Correspondingly, there is a need for the development of appealing and acceptable patient activation and shared decision-making tools that support young people to ask questions independently and raise the issues they want to discuss.

    Young people have advised that technology that is engaging, easy to access, informative, empowering, and provides support between sessions would be a particularly useful addition to therapy [25]. The use of technology in some areas of mental health care is recommended by the National Institute for Health and Care Excellence 2011 best practice guidance [26]. Indeed, young people report already using technology as an informal complement to treatment [25]. In Great Britain, 82% of adults use the internet daily and 70% of adults use the internet on smartphones [27]. Some 83% of young people aged 11 to 18 years own a smartphone and use mobile internet daily [28,29]. The growth in the smartphone and tablet market and the high levels of engagement within mobile app usage mean that there has been a rise in the adoption of mobile health care apps. The mobile health care market was estimated to be worth US $25.39 billion in 2017 [30].

    Young people, carers, and clinicians report feeling positive about integrating the use of certain apps into interventions for young people in mental health settings [16]. However, the content of many youth mental health apps is not grounded in psychological theory or evidence-based practice [31]. There is a need for evidence from rigorous trials as to the effectiveness of digital interventions for mental health in young people [32], in addition to research investigating how best to integrate these apps into support provision [25]. To plan rigorous trials to examine effectiveness, feasibility trials are needed [33]. In particular, there is a need for feasibility trials to determine (1) the usage and acceptability of digital interventions for youth mental health and (2) the ability to recruit and retain research participants [34,35].

    Aims and Objectives

    The aim of this study was to determine the feasibility of examining the effectiveness of a smartphone and tablet app, Power Up, in a prospective cluster randomized controlled trial and to determine the usage and acceptability of Power Up. In addition, we examined the ability to recruit and retain research participants. The app was designed to increase a young person’s patient activation related to their mental health by providing tools to support their voice in therapy, facilitate a more patient-centered approach, and increase shared decision making. The app was developed in partnership with young people and advocates to increase its acceptability to young people. Power Up enables young people to record their questions, plans, decisions, and diary entries and supports young people to identify individuals in their support network with whom they would like to share these entries. By providing a digital space for young people to prepare what they want to bring to conversations about their mental health and well-being, Power Up was designed to empower young people to take an active role in decisions that impact their health and care. Both professionals and young people with lived experience were involved in the design of Power Up, ensuring that the views of all relevant groups were heard during app development.

    The objective of the present feasibility trial was to collect the necessary parameters to plan a cluster control effectiveness trial of Power Up. In line with guidelines on conducting feasibility trials [36], the Trial Steering Committee developed Go and No Go criteria to determine whether or not the findings from this study indicated that it would be feasible to examine the effectiveness of Power Up in a full trial.


    Methods

    Overview

    A protocol for the feasibility trial was published [37] and registered with trials registries. To determine the feasibility of examining the effectiveness of Power Up in a prospective cluster randomized controlled trial, the Trial Steering Committee agreed the following Go and No Go criteria for the study. In line with guidance on conducting feasibility trials [36], we did not set any criteria related to effectiveness as the aims of this study were to collect the parameters necessary to plan the full trial and ensure an analysis of effectiveness was adequately powered. The criteria for the feasibility study are presented in Textbox 1.


    Textbox 1. Go and No Go criteria for the feasibility study.
    View this box

    Changes to Protocol

    We had initially planned to only conduct the feasibility trial in specialist Child and Adolescent Mental Health Services (CAMHS). We added a schools strand to the feasibility trial for 2 reasons. First, it became clear from feedback from service users, professionals, and researchers that Power Up was applicable to settings beyond specialist mental health services to empower young people to self-manage emotional well-being. Second, the rate of recruitment from specialist services was slower than anticipated, because of various reasons such as clinician workload, turnover, and either young people not attending appointments, not meeting study inclusion criteria, or both. Correspondingly, the target audience for Power Up expanded during the course of the study from just young people experiencing mental health problems to young people in schools to support self-management of emotional well-being.

    Recruitment

    In the feasibility trial, young people’s experiences while using Power Up were compared with young people’s experiences without using the app. Overall, 270 young people were screened for participation across 8 specialist services (n=79) and 2 mainstream secondary schools (n=191) (the demographics are reported in the Results section).

    For the specialist services strand of the trial, a wait list control design was employed. Initially, 33 young people were recruited to the control phase of the trial where they received management as usual (average cluster size 4.13 (SD 3.48)). Subsequently, 30 different young people were recruited to the intervention phase of the trial where they were given Power Up to use alongside management as usual (average cluster size 3.75 (SD 3.20)). This study was given a favorable opinion by the Health Research Authority Research Ethics Committee (reference number: 192592). Clinicians identified young people who were aged 11 to 19 years and were in their initial assessment sessions for recruitment to the trial. Once consent had been given, young people completed a questionnaire containing a battery of measures. Study measures included (1) the Patient Activation Measure [4] to assess young people’s empowerment and self-management of their mental health and well-being, (2) the CollaboRATE [38] and the Shared Decision Making Questionnaire 9 [39] to assess shared decision making, (3) the Youth Empowerment Scale—Mental Health [40] to assess young people’s confidence to manage their mental health (ie, self-subscale) and the support they receive from services (ie, service subscale), (4) the Strengths and Difficulties Questionnaire [41] to assess young people’s mental health, and (5) the Experience of Service Questionnaire [42] to assess young people’s experiences within mental health services. In the intervention condition, young people were then provided instructions on how to download and use the app. After 3 months, all participants and clinicians were recontacted by the researchers and asked to complete the same questionnaires. Participants in the intervention phase were also asked if they would like to participate in a short semistructured interview about the acceptability of Power Up.

    For the schools strand of the trial, a cluster randomized design was employed. Students in 12 clusters (classes) across 2 schools were randomized at the class level to either receive the app or not. This study was given a favorable opinion by University College London Research Ethics Committee (reference number: 6087/006). Randomization was achieved by using random number generation resulting in 6 intervention arm clusters, with 44 students allocated to receive Power Up (average cluster size 6.50 (SD 1.87)). The remaining 6 clusters were randomized to the control arm, with 50 students allocated to receive management as usual (average cluster size 7.50 (SD 4.04)). Researchers explained the nature of the research to the students before inviting them to take part. Participants gave their written consent and completed a questionnaire containing a similar battery of measures compared with that of the specialist services group, but excluding the shared decision-making measures: (1) the Patient Activation Measure [4] to assess young people’s empowerment and self-management of their mental health and well-being, (2) the Strengths and Difficulties Questionnaire [41] to assess young people’s mental health, (3) the Short Warwick-Edinburgh Mental Well-Being Scale [43] to assess young people’s well-being, and (4) the child-friendly version of the EuroQol five dimension quality of life measure [44] to assess young people’s quality of life and to inform the feasibility of conducting health economic analysis. Subsequently, those randomized to the intervention arm were given verbal instructions on how to use and download the Power Up app. After 6 weeks, all participants were contacted by researchers and asked to complete the same questionnaire measures. Participants in the intervention arm were also invited to participate in a short semistructured interview about the acceptability of Power Up.

    Intervention

    Power Up was developed based on the theory of patient activation [4] and a scoping review of tools to support young people to be actively involved in decisions about their care [45]. Power Up was designed to be a transdiagnostic and transtherapeutic intervention. To ensure it was accessible to young people, Power Up was co-designed with young people, carers, and clinicians through patient and public involvement workshops and interviews (see [46] for full details on the development of Power Up). A key topic of the codesign sessions was to ensure Power Up was simple and easy to use requiring minimal cognitive load so it could be used by a range of young people with different language skills, literacy levels, and experience of current distress. A mixture of text and icons is used and users can customize the iconography as straight-lined (aimed at older age ranges) or cartoon-style (aimed at younger age ranges). The main features of Power Up are described in Textbox 2 and Figure 1.


    Textbox 2. Main features of Power Up.
    View this box
    Figure 1. Power Up screenshots.
    View this figure

    Statistical Analysis

    To inform the planning of a prospective cluster randomized controlled trial, participant recruitment and retention was captured using the Consolidated Standards of Reporting Trials guidelines. Descriptive statistics were analyzed using SPSS (IBM Corp) [47]. Posttrial interviews were analyzed using thematic analysis [48] in NVivo (QSR International Pty Ltd.) [49].


    Results

    Recruitment and Retention

    Recruitment and retention are reported in the Consolidated Standards of Reporting Trials diagram in Figure 2. During recruitment, 270 young people were assessed for eligibility. A number of young people were screened for participation but not recruited, because of reasons such as refusal and practical barriers such as not having enough time on the day of the research team’s visit; for example, some young people and carers in specialist services were interested in the study but not able to stay to discuss the study as their parking was due to expire after their appointment. A further small proportion was excluded from the trial because of failing to complete all fields on their informed consent forms or failing to return study materials. In total, 142 participants were recruited and completed Time 1 measures (specialist services: n=62, mean age 14.66 (SD 1.99) years, 52% (32/62) female, 42% (26/62) white or white British; schools: n=80; mean 16.88 (SD 0.68), 46% (37/80) female, 26% (21/80) white or white British; see Table 1 for full demographic details). Of those who completed Time 1 measures, 64 (45%, 64/142) adhered to the study protocol and completed Time 2 follow-up assessments. All specialist services and school sites were retained in the study (N=10).

    Figure 2. Consolidated Standards of Reporting Trials diagram: combined flow of participants through the study across both specialist services and schools strands of the trial.
    View this figure
    Table 1. Participant demographics.
    View this table

    User Statistics

    We could only determine a number of new users during the entire project time frame from January 2017 to February 2018. The number of active sessions and duration of sessions were available between November 2017 and February 2018 as the app developers upgraded the activity data capture system during the feasibility trial. App usage data are anonymous to comply with data protection and research ethics approvals. Overall, there were 70 new users between January 2017 and February 2018, of which we estimate 20 were nonintervention arm participants (ie, 5 members of the research team, 2 app developers, and 13 clinicians) resulting in an estimated 50 users of Power Up in the intervention arm, out of 64 participants allocated to this arm. There were 13 active users between November 2017 and February 2018 and these users used the app in 89 active usage sessions (corresponding to 6.8 sessions per active user) with an average of 8 min per session.

    Posttrial Interviews

    Posttrial interviews were conducted with 11 young people from the intervention arms of the feasibility trial (specialist services n=6; schools n=5; mean age 15.55 (1.86), range=11-17 years). Interviews were audio recorded and transcribed verbatim. Young people described their experiences of using Power Up and of its impact on self-management and well-being, including the context of app use and suggested amendments to the app. The analysis also provided understanding as to barriers faced by young people to downloading and using the app. Finally, interviews indicated the acceptability of Power Up, which will inform the prospective cluster control trial. Findings from the interviews are reported below relating to (1) motivation for use of Power Up, (2) impact of use, and (3) barriers to use (the themes, descriptions, and quotes from the posttrial interviews are fully reported in Textbox 3). We aimed to recruit 10 to 12 young people as we expected this would be sufficient for saturation, which was achieved. We report on these interviews in this study and discuss the views of clinicians, parents and carers on the development of Power Up elsewhere [46] and we have reported in detail on teachers’ views and experiences of the implementation of another digital intervention [50].


    Textbox 3. Themes, descriptions, and quotes from posttrial interviews.
    View this box

    Discussion

    Principal Findings

    The aim of this study was to determine the feasibility of examining the effectiveness of Power Up in a prospective cluster randomized controlled trial and to determine the usage and acceptability of Power Up and the ability to recruit and retain participants. A feasibility trial of Power Up was conducted in specialist services and school settings. The findings from this study indicate that it is feasible to examine the effectiveness of Power Up in a prospective trial: the overall score of the Go and No Go criteria was 2 and the Trial Steering Committee have agreed on the plan to increase adherence to the criteria that were partially met. For each criterion, we have reported achievement and described facilitators and barriers to achievement to inform planning of the future trial.

    The total score of the Go and No Go criteria was 2, as there were 3 criteria fully met and 2 partially met. The study will be able to proceed as the Trial Steering Committee has agreed the plan to increase adherence to the 2 amber criteria. Recruitment and retention (criteria 2 and 5) will be increased by clarifying research sites’ expectations from the outset, increasing ease of completing measures, and removing other barriers to participation (see Textbox 4). To further increase retention, barriers to downloading and using Power Up have also been removed by enabling participants to directly download the app from public app stores. As the app was still under development during the feasibility trial, Power Up was not fully available and participants were required to download Power Up using test software through the app developers; the new approach has removed this barrier. The developers have also upgraded the activity data capture system meaning we will be able to fully monitor adherence in the full trial.

    The ultimate output of the project will be used by young people with emotional difficulties or other long-term conditions, aiming to empower self-management of problems. It is envisaged that Power Up will be developed for use with young people with other long-term conditions, and in other countries, however, future research is warranted to determine how Power Up should be modified for use with other conditions and in other contexts. Uptake of and engagement with novel digital technologies to support self-management of mental health difficulties and to promote decision making and well-being may be hindered if young people, their carers, teachers, and health professionals do not endorse them. The model of this study, cocreating Power Up with young people, carers, and professionals, will help to overcome this barrier by ensuring that Power Up meets the needs of these stakeholders and by providing young people with a sense of ownership in the knowledge that other young people have helped to create the resource.


    Textbox 4. Adherence to the Go and No Go criteria.
    View this box

    Limitations

    The scope of the feasibility trial was expanded to include young people from schools, in addition to young people from specialist services. Although this was based on feedback from young people, carers, and professionals that Power Up could be useful in settings beyond specialist services, it was also based on the slow recruitment rate from specialist services. We have developed plans to increase recruitment and retention for the full trial. This study was a feasibility trial, meaning definitive conclusions about the effectiveness of Power Up cannot be drawn. It was not possible to blind young people about their allocation in the feasibility trial, and it will not be possible to do so in the full trial. As with digital and psychotherapy research in general, a lack of allocation concealment and a reliance on self-report measures will be limitations that should be considered when interpreting any findings from future studies of Power Up. The Trial Steering Committee did consider using a restricted version of the app for the control condition, for example, only with the diary function. Although there is clinical equipoise, young people and clinicians indicated a strong preference not to include a placebo intervention, especially as young people may be unlikely to adhere to such a minimal intervention, minimizing the usefulness of comparisons. Nevertheless, in future research, independent randomization using a true randomization generator, intention-to-treat analysis, and monitoring and reporting of usage of Power Up will be methodological strengths. We will also be able to fully examine the relationship between a young person’s characteristics (eg, age, gender, and presenting problems) and the effect of Power Up.

    Conclusions

    A feasibility trial of Power Up was conducted in specialist services and school settings. The findings from this study indicate that it is feasible to examine the effectiveness of Power Up in a prospective cluster randomized controlled trial: the overall score of the Go and No Go criteria was 2 and the Trial Steering Committee have agreed on the plan to increase adherence to the criteria that were partially met. This study addresses the call for feasibility trials of digital mental health interventions for young people [34,35]. Future research is needed to determine whether Power Up can be used by young people with emotional difficulties or other long-term conditions to empower them to self-manage difficulties.

    Acknowledgments

    The study was funded by the National Institute for Health Research (NIHR) Invention for Innovation Programme (i4i) project number: II-LA-0814-20005. CH and MC acknowledge the financial support of the NIHR MindTech MedTech Co-operative and NIHR Nottingham Biomedical Research Centre. The views expressed are those of the author(s) and not necessarily those of the National Health Service (NHS), the NIHR, or the Department of Health and Social Care. The research was supported by the NIHR Collaboration for Leadership in Applied Health Research and Care North Thames at Bart’s Health NHS Trust. The views expressed are those of the authors and not necessarily those of the NHS, the NIHR, or the Department of Health and Social Care. The research team acknowledges the support of the NIHR Clinical Research Network.

    Conflicts of Interest

    None declared.

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    Abbreviations

    CAMHS: Child and Adolescent Mental Health Service
    MoU: Memorandum of Understanding
    NHS: National Health Service
    NIHR: National Institute for Health Research


    Edited by G Eysenbach; submitted 25.07.18; peer-reviewed by J Oldenburg, S Rush; comments to author 06.09.18; revised version received 22.10.18; accepted 24.10.18; published 04.06.19

    ©Julian Edbrooke-Childs, Chloe Edridge, Phoebe Averill, Louise Delane, Chris Hollis, Michael P Craven, Kate Martin, Amy Feltham, Grace Jeremy, Jessica Deighton, Miranda Wolpert. Originally published in JMIR Mhealth and Uhealth (http://mhealth.jmir.org), 04.06.2019.

    This is an open-access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in JMIR mhealth and uhealth, is properly cited. The complete bibliographic information, a link to the original publication on http://mhealth.jmir.org/, as well as this copyright and license information must be included.