Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT05729516

The Hope App Study

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

See Yourself Health

Beverly, Massachusetts, 01915, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Hope App immersive learning and telehealth platform

Behavioral

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.

Primary outcomes

  1. change in glycemic control

    Time frame: baseline and 6 months

    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.

Secondary outcomes

  1. changes in self-reported diabetes distress

    Time frame: baseline to 3 months; 3 months to 6 months; baseline to 6 months

    self-reported changes in diabetes distress scale

  2. self-reported weight change

    Time frame: baseline to 3 months; 3 months to 6 months; baseline to 6 months

    self-reported weight change in pounds

  3. changes in participant engagement

    Time frame: baseline to 3 months; 3 months to 6 months; baseline to 6 months

    proportion of utilization metrics met (frequency of use, feature interactions)

  4. changes in self-management adherence

    Time frame: baseline to 3 months; 3 months to 6 months; baseline to 6 months

    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)).

  5. changes in medication adherence scale

    Time frame: baseline to 3 months; 3 months to 6 months; baseline to 6 months

    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.

  6. changes in depressive burden symptoms

    Time frame: baseline to 3 months; 3 months to 6 months; baseline to 6 months

    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.

  7. changes in general anxiety symptoms

    Time frame: baseline to 3 months; 3 months to 6 months; baseline to 6 months

    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.

  8. changes in coping skills

    Time frame: baseline to 3 months; 3 months to 6 months; baseline to 6 months

    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.

  9. changes in perceived support from healthcare providers

    Time frame: baseline to 3 months; 3 months to 6 months; baseline to 6 months

    self-reported changes in Healthcare Climate Questionnaire

  10. changes in perceived competence

    Time frame: baseline to 3 months; 3 months to 6 months; baseline to 6 months

    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.

  11. changes in perceived diabetes self-efficacy

    Time frame: baseline to 3 months; 3 months to 6 months; baseline to 6 months

    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.

Sponsors and collaborators

Lead sponsor

See Yourself Health LLC

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Feb 15, 2023
Registry last updated
Apr 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.