The Hope App Study

Study Overview
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Brief Summary
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This research study will test how a computer program (called the Hope App) teaches diabetes care skills for older adults with diabetes. The study will compare those who receive diabetes education (10 educational modules and monthly health coaching) through the research program with those who receive care as usual.

Detailed Description
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The Hope App offers a simple, high-impact, engaging, and immersive telehealth experience with the potential to become a ubiquitous diabetes management tool to transform diabetes patients into high performing drivers of their own care. The research team aims to scale the platform, develop features that are important to aging adults, and run a clinical trial to validate the Hope App's health benefits. Specific Aim 1: Develop the Hope App's state-of-the-art immersive patient engagement experience with automated onboarding, social networking and gamified DSME/S features to support long-term patient retention. In doing so, usability testing will be performed to ensure patient-facing features on the platform and patient-facing content and curriculum materials are functioning and well received by participants. Specific Aim 2: Develop the Hope App's predictive analytic capabilities for population health management. Specific Aim 3: Conduct a clinical validation trial of the Hope App intervention on six-month clinical outcomes (Hemoglobin A1c), patient reported outcomes (diabetes distress) and engagement outcomes (patient retention, adherence to self-care behaviors). The research team intends to deliver a scalable Hope App platform with a usable patient engagement portal designed for older adults and achieve decreases in blood glucose levels (HbA1c) and depressive burden, and sustained patient engagement.

Official Title
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The Hope App: An Immersive Telehealth Solution for Older Adults With Diabetes

Conditions
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Type 2 Diabetes

Intervention / Treatment
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* Behavioral: Hope App immersive learning and telehealth platform


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: aged 65 years and above diagnosis of type 2 diabetes English-speaking baseline blood sugar value (HbA1c) of 7.5% Internet access Exclusion Criteria: aged less than 65 years non English-speaking unable to provide informed consent diagnosis of type 1 diabetes unable to use a computer or mobile device medical condition for which participation is contraindicated (dialysis, pregnancy, use of insulin pump)

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This is a wait-list control study design. Participants are assigned to one of two groups at random (intervention and wait list) for 6 months. After 6 months, participants in the wait list group are able to receive the intervention.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Immediate Treatment Group (ITG)<br>ITG participants receive access to the Hope App, a newly designed immersive learning and telehealth application designed to deliver engaging diabetes care and self-management education and support for older adults with diabetes. ITG participants also complete data collection (surveys and HbA1c measurements) at baseline, 3 months after baseline, and 6 months after baseline. | Behavioral: Hope App immersive learning and telehealth platform<br>* As part of the Hope App intervention, participants attend 10 skills sessions related to diabetes self-management. ITG participants will also receive monthly health coaching calls. After 6 months of active participation, participants enter a maintenance period, during which programming concludes but continued access to the program materials remains.<br>|
| No Intervention: Wait List Control (WLC)<br>WLC participants receive care as usual for 6 months. They will complete data collection (surveys and HbA1c measurements) at baseline, 3 months after baseline, and 6 months after baseline. After 6 months, WLC participants will gain access to the Hope App and receive diabetes programming and health coaching for the remaining 6 months. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in glycemic control | change in HbA1c values recorded from point-of-care tests or in the electronic health record at visits. A mean change of 0.5% will be the a priori determined clinically meaningful minimum improvement from baseline to 6 months. | baseline and 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changes in self-reported diabetes distress | self-reported changes in diabetes distress scale | baseline to 3 months; 3 months to 6 months; baseline to 6 months | 
| self-reported weight change | self-reported weight change in pounds | baseline to 3 months; 3 months to 6 months; baseline to 6 months | 
| changes in participant engagement | proportion of utilization metrics met (frequency of use, feature interactions) | baseline to 3 months; 3 months to 6 months; baseline to 6 months | 
| changes in self-management adherence | self-reported changes in the 11-item Summary of Diabetes Self-Care Activities Assessment. The first 10 items are summed to a total score and averaged to 5 scale scores; the scales are General Diet, Specific Diet, Exercise, Blood-Glucose Testing, and Foot Care. Mean number of days will be assessed for self-management behaviors. The 11th question assess smoking status (yes(1), no(0)). | baseline to 3 months; 3 months to 6 months; baseline to 6 months | 
| changes in medication adherence scale | self-reported changes in the Morisky Medication Adherence scale. There are 4-item and 8-item versions with higher scores indicating higher levels of adherence to medication. | baseline to 3 months; 3 months to 6 months; baseline to 6 months | 
| changes in depressive burden symptoms | self-reported changes in Patient Health Questionnaire (PHQ)-9. PHQ-9 total score over nine items ranges from 0-24, with higher scores indicative of greater depressive symptom burden. | baseline to 3 months; 3 months to 6 months; baseline to 6 months | 
| changes in general anxiety symptoms | self-reported changes in General Anxiety Disorder (GAD)-7 questionnaire. GAD-7 total score over seven items ranges from 0-21, with higher scores indicative of increased symptoms of anxiety. | baseline to 3 months; 3 months to 6 months; baseline to 6 months | 
| changes in coping skills | self-reported changes to Brief Resilient Coping Scale. The total score over 4 items ranges from 4-20, with higher scores indicative of high resilient coping. | baseline to 3 months; 3 months to 6 months; baseline to 6 months | 
| changes in perceived support from healthcare providers | self-reported changes in Healthcare Climate Questionnaire | baseline to 3 months; 3 months to 6 months; baseline to 6 months | 
| changes in perceived competence | self-reported changes in Perceived Competence in Diabetes Scale. There are 4-items on a Likert scale from 1-7 with higher scores representing a higher degree to which people with diabetes feel they can self-manage their diabetes. The mean score is used as a summary score. | baseline to 3 months; 3 months to 6 months; baseline to 6 months | 
| changes in perceived diabetes self-efficacy | self-reported changes in diabetes self-efficacy scale. There are 8 items on a Likert scale from 1 to 10. The score for the scale is the mean of the eight items. Higher number is indicative of higher self-efficacy. | baseline to 3 months; 3 months to 6 months; baseline to 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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older adults, telehealth