The Hope App Study

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Type 2 Diabetes
• Intervention / Treatment: Behavioral: Hope App immersive learning and telehealth platform

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Beverly, Massachusetts, United States, 01915
      • See Yourself Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Immediate Treatment Group (ITG); 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; 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.
No Intervention: Wait List Control (WLC); 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?

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 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
changes in medication adherence scale	self-reported changes in the Medication Adherence Report Scale (MARS-5). There is also a 10-item version. The 5-item version asks respondents to rate the frequency with which the five different medication-taking behaviors occur, scoring each item on a five-point scale (5 = never to 1 = very often), with higher scores indicating higher levels of adherence to medication.	baseline to 3 months; 3 months to 6 months; baseline to 6 months

Collaborators and Investigators

• Sponsor: See Yourself Health LLC
• Collaborators: University of Louisville
• Investigators: Principal Investigator: Suzanne Mitchell, MD, MS, See Yourself Health LLC

Study record dates

Study Major Dates

• Study Start (Actual): May 24, 2024
• Primary Completion (Estimated): July 1, 2025
• Study Completion (Estimated): August 1, 2025

Study Registration Dates

• First Submitted: December 22, 2022
• First Submitted That Met QC Criteria: February 6, 2023
• First Posted (Actual): February 15, 2023

Study Record Updates

• Last Update Posted (Actual): April 24, 2025
• Last Update Submitted That Met QC Criteria: April 21, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: older adults; telehealth
• Other Study ID Numbers: 2022/06/30

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No