An interventional study of Hope App immersive learning and telehealth platform in Type 2 Diabetes, sponsored by See Yourself Health LLC. Active, not recruiting at 1 site in United States. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2025-04-24.
Sponsored by See Yourself Health LLC · Not applicable, Interventional, and Treatment
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.
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.
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.
This is the only study on the registry with See Yourself Health LLC as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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.
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.
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.
Time frame: baseline and 6 months
changes in self-reported diabetes distress
self-reported changes in diabetes distress scale
Time frame: baseline to 3 months; 3 months to 6 months; baseline to 6 months
self-reported weight change
self-reported weight change in pounds
Time frame: 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)
Time frame: 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)).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: baseline to 3 months; 3 months to 6 months; baseline to 6 months
Plan to share: No
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
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