The Hope App Study

NCT05729516 | Active Not Recruiting

• 1 other identifier: 2022/06/30
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Type 2 Diabetes

Keywords

older adults; telehealth

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• changes in self-reported diabetes distress

  baseline to 3 months; 3 months to 6 months; baseline to 6 months

• self-reported weight change

  baseline to 3 months; 3 months to 6 months; baseline to 6 months

• changes in participant engagement

  baseline to 3 months; 3 months to 6 months; baseline to 6 months

• changes in self-management adherence

  baseline to 3 months; 3 months to 6 months; baseline to 6 months

• changes in medication adherence scale

  baseline to 3 months; 3 months to 6 months; baseline to 6 months

Study Arms (2)

Immediate Treatment Group (ITG)

EXPERIMENTAL

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

Wait List Control (WLC)

NO INTERVENTION

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.

Interventions

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.

Immediate Treatment Group (ITG)

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• aged 65 years and above
• diagnosis of type 2 diabetes
• English-speaking
• baseline blood sugar value (HbA1c) of 7.5%
• Internet access

You may not qualify if:

• 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)

Sponsors & Collaborators

• See Yourself Health LLC: lead

Study Sites (1)

See Yourself Health

Beverly, Massachusetts, 01915, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Suzanne Mitchell, MD, MS

  See Yourself Health LLC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: December 22, 2022
• First Posted: February 15, 2023
• Study Start: May 24, 2024
• Primary Completion: July 1, 2025
• Study Completion: August 1, 2025
• Last Updated: April 24, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)