The Hope App Study

Type 2 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05729516
• Other study ID #: 2022/06/30
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 2024
• Est. completion date: August 2024

Study information

• Verified date: January 2024
• Source: See Yourself Health LLC
• Contact: Suzanne Mitchell, MD, MS
• Phone: 570-324-4928
• Email: smitchell[@]seeyourselfhealth.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: August 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Type 2 Diabetes

Intervention

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.

Locations

Country	Name	City	State
United States	University of Louisville	Louisville	Kentucky

Sponsors (2)

Lead Sponsor	Collaborator
See Yourself Health LLC	University of Louisville

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	self-reported weight change	self-reported weight change in pounds	baseline to 3 months; 3 months to 6 months; baseline to 6 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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