Clinical trial NCT05729516: The Hope App Study
Official title: The Hope App: An Immersive Telehealth Solution for Older Adults With Diabetes
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Type 2 Diabetes
Keywords: older adults
telehealth
Lead sponsor: See Yourself Health LLC
Sponsor class: OTHER
First posted: 2023-02-15
Enrollment: 150
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: 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)

Primary outcomes:
measure: change in glycemic control
timeFrame: baseline and 6 months
Secondary outcomes:
measure: changes in self-reported diabetes distress
timeFrame: baseline to 3 months; 3 months to 6 months; baseline to 6 months
measure: self-reported weight change
timeFrame: baseline to 3 months; 3 months to 6 months; baseline to 6 months
measure: changes in participant engagement
timeFrame: baseline to 3 months; 3 months to 6 months; baseline to 6 months
measure: changes in self-management adherence
timeFrame: baseline to 3 months; 3 months to 6 months; baseline to 6 months
measure: changes in medication adherence scale
timeFrame: baseline to 3 months; 3 months to 6 months; baseline to 6 months
measure: changes in depressive burden symptoms
timeFrame: baseline to 3 months; 3 months to 6 months; baseline to 6 months
measure: changes in general anxiety symptoms
timeFrame: baseline to 3 months; 3 months to 6 months; baseline to 6 months
measure: changes in coping skills
timeFrame: baseline to 3 months; 3 months to 6 months; baseline to 6 months
measure: changes in perceived support from healthcare providers
timeFrame: baseline to 3 months; 3 months to 6 months; baseline to 6 months
measure: changes in perceived competence
timeFrame: baseline to 3 months; 3 months to 6 months; baseline to 6 months
measure: changes in perceived diabetes self-efficacy
timeFrame: baseline to 3 months; 3 months to 6 months; baseline to 6 months
Other outcomes:
Locations:
city: Beverly
country: United States
facility: See Yourself Health
state: Massachusetts
Study officials:
affiliation: See Yourself Health LLC
name: Suzanne Mitchell, MD, MS
role: PRINCIPAL_INVESTIGATOR
References: