The Hope App Study

See Yourself Health LLC

Status: Active, not recruiting

Conditions: Type 2 Diabetes

Treatments: Behavioral: Hope App immersive learning and telehealth platform

Study type: Interventional

Funder types: Other

Identifiers

NCT05729516

2022/06/30

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 estimated patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 2 patient groups

Immediate Treatment Group (ITG)

Experimental group

Description:

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.

Treatment:

Behavioral: Hope App immersive learning and telehealth platform

Wait List Control (WLC)

No Intervention group

Description:

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.