Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
150 participants
INTERVENTIONAL
2024-05-24
2025-08-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Immediate Treatment Group (ITG)
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.
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.
Wait List Control (WLC)
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.
No interventions assigned to this group
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* diagnosis of type 2 diabetes
* English-speaking
* baseline blood sugar value (HbA1c) of 7.5%
* Internet access
Exclusion Criteria
* 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)
65 Years
ALL
No
Sponsors
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See Yourself Health LLC
OTHER
Responsible Party
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Principal Investigators
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Suzanne Mitchell, MD, MS
Role: PRINCIPAL_INVESTIGATOR
See Yourself Health LLC
Locations
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See Yourself Health
Beverly, Massachusetts, United States
Countries
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Other Identifiers
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2022/06/30
Identifier Type: -
Identifier Source: org_study_id
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