Dataset Information

A Mobile- and Web-Based Health Intervention Program for Diabetes and Prediabetes Self-Management (BetaMe/Melon): Process Evaluation Following a Randomized Controlled Trial.

ABSTRACT: Background:Technology-assisted self-management programs are increasingly recommended to patients with long-term conditions such as diabetes. However, there are a number of personal and external factors that affect patients' abilities to engage with and effectively utilize such programs. A randomized controlled trial of a multi-modal online program for diabetes self-management (BetaMe/Melon) was conducted in a primary care setting, and a process evaluation was completed at the end of the study period.

Objective:This process evaluation aimed to examine the utilization patterns of BetaMe/Melon, identify which components participants found most (and least) useful, and identify areas of future improvement.

Methods:Process evaluation data were collected for intervention arm participants from 3 sources: (1) the mobile/web platform (to identify key usage patterns over the 16-week core program), (2) an online questionnaire completed during the final study assessment, and (3) interviews conducted with a subset of participants following the study period. Participants were classified as "actively engaged" if any usage data was recorded for the participant (in any week), and patterns were reported by age, gender, ethnicity, and diabetes/prediabetes status. The online questionnaire asked participants about the usefulness of the program and whether they would recommend BetaMe/Melon to others according to a 5-point Likert Scale. Of 23 invited participants, 18 participated in a digitally recorded, semistructured telephone interview. Interview data were thematically analyzed.

Results:Out of the 215 participants, 198 (92%) received an initial health coaching session, and 160 (74%) were actively engaged with the program at some point during the 16-week core program. Engagement varied by demographic, with women, younger participants, and ethnic majority populations having higher rates of engagement. Usage steadily declined from 50% at Week 0 to 23% at Week 15. Participants ranked component usefulness as education resources (63.7%), health coaches (59.2%), goal tracking (48.8%), and online peer support (42.1%). Although 53% agreed that the program was easy to use, 64% would recommend the program to others. Interview participants found BetaMe/Melon useful overall, with most identifying beneficial outcomes such as increased knowledge, behavioral changes, and weight loss. Barriers to engagement were program functionality, internet connectivity, incomplete delivery of all program components, and participant motivation. Participants suggested a range of improvements to the BetaMe/Melon program.

Conclusions:The program was generally well received by participants; active engagement was initially high, although it declined steadily. Maintaining participant engagement over time, individualizing programs, and addressing technical barriers are important to maximize potential health benefits from online diabetes self-management programs.

Trial registration:Australian New Zealand Clinical Trial Registry ACTRN12617000549325; https://tinyurl.com/y622b27q.

SUBMITTER: Signal V

PROVIDER: S-EPMC7738254 | biostudies-literature | 2020 Dec

REPOSITORIES: biostudies-literature

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A Mobile- and Web-Based Health Intervention Program for Diabetes and Prediabetes Self-Management (BetaMe/Melon): Process Evaluation Following a Randomized Controlled Trial.

Signal Virginia V McLeod Melissa M Stanley James J Stairmand Jeannine J Sukumaran Nitin N Thompson Donna-Marie DM Henderson Kelly K Davies Cheryl C Krebs Jeremy J Dowell Anthony A Grainger Rebecca R Sarfati Diana D

Journal of medical Internet research 20201201 12

<h4>Background</h4>Technology-assisted self-management programs are increasingly recommended to patients with long-term conditions such as diabetes. However, there are a number of personal and external factors that affect patients' abilities to engage with and effectively utilize such programs. A randomized controlled trial of a multi-modal online program for diabetes self-management (BetaMe/Melon) was conducted in a primary care setting, and a process evaluation was completed at the end of the ...[more]

PMID: 33258776

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Project description:BackgroundMobile health (m-health) work in low- and middle-income countries (LMICs) mainly consists of small pilot programs with an unclear path to scaling and dissemination. We describe the deployment and testing of an m-health platform for non-communicable disease (NCD) self-management support in Bolivia.MethodsThree hundred sixty-four primary care patients in La Paz with diabetes or hypertension completed surveys about their use of mobile phones, health and access to care. One hundred sixty-five of those patients then participated in a 12-week demonstration of automated telephone monitoring and self-management support. Weekly interactive voice response (IVR) calls were made from a platform established at a university in La Paz, under the direction of the regional health ministry.ResultsThirty-seven percent of survey respondents spoke indigenous languages at home and 38% had six or fewer years of education. Eighty-two percent had a mobile phone, 45% used text messaging with a standard phone, and 9% had a smartphone. Smartphones were least common among patients who were older, spoke indigenous languages, or had less education. IVR program participants completed 1007 self-management support calls with an overall response rate of 51%. IVR call completion was lower among older adults, but was not related to patients' ethnicity, health status, or healthcare access. IVR health and self-care reports were consistent with information reported during in-person baseline interviews. Patients' likelihood of reporting excellent, very good, or good health (versus fair or poor health) via IVR increased during program participation and was associated with better medication adherence. Patients completing follow-up interviews were satisfied with the program, with 19/20 (95%) reporting that they would recommend it to a friend.ConclusionBy collaborating with LMICs, m-health programs can be transferred from higher-resource centers to LMICs and implemented in ways that improve access to self-management support among people with NCDs.

Project description:BackgroundThe Scleroderma Patient-centered Intervention Network (SPIN) developed an online self-management program (SPIN-SELF) designed to improve disease-management self-efficacy in people with systemic sclerosis (SSc, or scleroderma). The aim of this study was to evaluate feasibility aspects for conducting a full-scale randomized controlled trial (RCT) of the SPIN-SELF Program.MethodsThis feasibility trial was embedded in the SPIN Cohort and utilized the cohort multiple RCT design. In this design, at the time of cohort enrollment, cohort participants consent to be assessed for trial eligibility and randomized prior to being informed about the trial. Participants in the intervention arm are informed and provide consent, but not the control group. Forty English-speaking SPIN Cohort participants from Canada, the USA, or the UK with low disease-management self-efficacy (Self-Efficacy for Managing Chronic Disease Scale [SEMCD] score ≤ 7) who were interested in using an online self-management program were randomized (3:2 ratio) to be offered the SPIN-SELF Program or usual care for 3 months. Program usage was examined via automated usage logs. User satisfaction was assessed with semi-structured interviews. Trial personnel time requirements and implementation challenges were logged.ResultsOf 40 SPIN Cohort participants randomized, 26 were allocated to SPIN-SELF and 14 to usual care. Automated eligibility and randomization procedures via the SPIN Cohort platform functioned properly, except that two participants with SEMCD scores > 7 (scores of 7.2 and 7.3, respectively) were included, which was caused by a system programming error that rounded SEMCD scores. Of 26 SPIN Cohort participants offered the SPIN-SELF Program, only 9 (35%) consented to use the program. Usage logs showed that use of the SPIN-SELF Program was low: 2 of 9 users (22%) logged into the program only once (median = 3), and 4 of 9 (44%) accessed none or only 1 of the 9 program's modules (median = 2).ConclusionsThe results of this study will lead to substantial changes for the planned full-scale RCT of the SPIN-SELF Program that we will incorporate into a planned additional feasibility trial with progression to a full-scale trial. These changes include transitioning to a conventional RCT design with pre-randomization consent and supplementing the online self-help with peer-facilitated videoconference-based groups to enhance engagement.Trial registrationclinicaltrials.gov , NCT03914781 . Registered 16 April 2019.

Project description:BackgroundIn addition to medical intervention and counseling, patients with cardiovascular disease (CVD) need to manage their disease and its consequences by themselves in daily life.ObjectiveThe aim of this paper is to describe the development of "Vascular View," a comprehensive, multi-component, tailored, Web-based, self-management support program for patients with CVD, and how this program will be tested in an early randomized controlled trial (RCT).MethodsThe Vascular View program was systematically developed in collaboration with an expert group of 6 patients, and separately with a group of 6 health professionals (medical, nursing, and allied health care professionals), according to the following steps of the intervention mapping (IM) framework: (1) conducting a needs assessment; (2) creating matrices of change objectives; (3) selecting theory-based intervention methods and practical applications; (4) organizing methods and applications into an intervention program; (5) planning the adaption, implementation, and sustainability of the program, and (6) generating an evaluation plan.ResultsThe needs assessment (Step 1) identified 9 general health problems and 8 determinants (knowledge, awareness, attitude, self-efficacy, subjective norm, intention, risk perception, and habits) of self-managing CVD. By defining performance and change objectives (Step 2), 6 topics were distinguished and incorporated into the courses included in Vascular View (Steps 3 and 4): (1) Coping With CVD and its Consequences; (2) Setting Boundaries in Daily Life; (3) Lifestyle (general and tobacco and harmful alcohol use); (4) Healthy Nutrition; (5) Being Physically Active in a Healthy Way; and (6) Interaction With Health Professionals. These courses were based on behavioral change techniques (BCTs) (eg, self-monitoring of behavior, modeling, re-evaluation of outcomes), which were incorporated in the courses through general written information: quotes from and videos of patients with CVD as role models and personalized feedback, diaries, and exercises. The adoption and implementation plan (Step 5) was set up in collaboration with the members of the two expert groups and consisted of a written and digital instruction manual, a flyer, bimonthly newsletters, and reminders by email and telephone to (re-)visit the program. The potential effectiveness of Vascular View will be evaluated (Step 6) in an early RCT to gain insight into relevant outcome variables and related effect sizes, and a process evaluation to identify intervention fidelity, potential working mechanisms, user statistics, and/or satisfaction.ConclusionA comprehensive, multi-component, tailored, Web-based, self-management support program and an early RCT were developed in order to empower patients to self-manage their CVD.Trial registrationNederlands Trial Register NTR5412; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=5412 (Archived by WebCite at http://www.webcitation.org/6jeUFVj40).

Project description:ImportanceIt is unclear whether mobile technology hypertension self-management programs are associated with blood pressure (BP) control.ObjectiveTo examine whether engagement with a hypertension self-management program with a BP monitor and connected smartphone application with clinically based digital coaching was associated with BP control during a follow-up period of as long as 3 years.Design, setting, and participantsThis cohort study enrolled US adults with elevated BP or hypertension between January 1, 2015, and July 1, 2020. The hypertension self-management program was provided through the participant's (or their spouse's) employer health plan.ExposuresProgram engagement, defined by average number of application sessions.Main outcomes and measuresSystolic and diastolic BP measured by a US Food and Drug Administration-cleared BP monitor, with categories defined as normal (systolic BP, <120 mm Hg), elevated (systolic BP, 120-129 mm Hg), stage 1 hypertension (systolic BP, 130-139 mm Hg), and stage 2 hypertension (systolic BP ≥140 mm Hg). Other measures included age, gender, depression, anxiety, diabetes, high cholesterol, smoking, geographic region, area deprivation index, self-reported weight, and device-measured physical activity (steps per day).ResultsAmong 28 189 participants (median [IQR] age, 51 [43-58] years; 9424 women [40.4%]; 13 902 men [59.6%]), median (IQR) baseline systolic BP was 129.5 mm Hg (120.5-139.6 mm Hg) and diastolic BP was 81.7 mm Hg (75.7-88.4 mm Hg). Median systolic BP at 1 year improved at least 1 category for 495 of 934 participants (53.0%) with baseline elevated BP, 673 of 966 (69.7%) with baseline stage 1 hypertension, and 920 of 1075 (85.7%) with baseline stage 2 hypertension. Participants in the program for 3 years had a mean (SEM) systolic BP reduction of 7.2 (0.4), 12.2 (0.7), and 20.9 (1.7) mm Hg compared with baseline for those starting with elevated, stage 1 hypertension, and stage 2 hypertension, respectively. Greater engagement was associated with lower systolic BP over time (high-engagement group: 131.2 mm Hg; 95% CI, 115.5-155.8 mm Hg; medium-engagement group: 133.4 mm Hg; 95% CI 116.3-159.5 mm Hg; low-engagement group: 135.5 mm Hg; 95% CI, 117.3-164.8 mm Hg; P < .001); these results persisted after adjusting for age, gender, depression, anxiety, diabetes, high cholesterol, smoking, area deprivation index rank, and US region, which was partially mediated by greater physical activity. A very high BP (systolic BP >180 mm Hg) was observed 11 637 times from 3778 participants. Greater engagement was associated with lower risk of very high BP; the estimated probability of a very high BP was greater in the low-engagement group (1.42%; 95% CI, 1.26%-1.59%) compared with the medium-engagement group (0.79%; 95% CI, 0.71%-0.87%; P < .001) and the high-engagement group (0.53%; 95% CI, 0.45%-0.60%; P < .001 for comparison with both groups).Conclusions and relevanceThe findings of this study suggest that a mobile technology hypertension self-management program can support long-term BP control and very high BP detection. Such programs may improve real-world BP monitoring and control.

Dataset Information

A Mobile- and Web-Based Health Intervention Program for Diabetes and Prediabetes Self-Management (BetaMe/Melon): Process Evaluation Following a Randomized Controlled Trial.

Publications

A Mobile- and Web-Based Health Intervention Program for Diabetes and Prediabetes Self-Management (BetaMe/Melon): Process Evaluation Following a Randomized Controlled Trial.

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