Advancing Diabetes Management for People With Physical Disabilities Optimally Through Primary Care-Based Telehealth (ADDOPT)

Sponsor
University of Alabama at Birmingham
Study ID
NCT07032844
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 89 Years
Healthy Volunteers
Not accepted

Interventions

  • Digital Health Coaching — BEHAVIORAL
    This program will be developed using existing, evidence-based curricula for chronic disease self-management, with emphasis on diabetes, hypertension, and obesity. Prior to initiating health coaching with participants, coaches will review data collected related to SDoH to further tailor the intervention as appropriate for housing stability, access to food and transportation, and interpersonal safety. All coaches will have access to participants' EMRs such that they can view medical information throughout the intervention. Coaches will be trained using a curriculum developed by Family and Community Medicine's inter-professional care team and our partners at NCHPAD, making the coaching inclusive of people with physical disabilities, such that the coaches are proficient in motivating behavior change related to resilience, physical activity, nutrition, mindfulness, and relationship-building, among others.
  • Phone Based Coaching — BEHAVIORAL
    Weekly coaching calls that address topics related to goal setting, creating supportive environments for behavior change, physical activity, and nutrition.
  • Combination of Digital Health coaching + Remote Patient Monitoring — BEHAVIORAL
    Combination of both digital health coaching and remote patient monitoring

Study Details

The purpose of the study is to compare 2 primary care based telehealth interventions- 1) digital health coaching and 2) remote patient monitoring for improving glycemic (blood sugar levels) control and overall health outcomes in individuals with physical disabilities, type 2 diabetes (T2DM) and at least one chronic condition. The project aims to determine which intervention is more effective in reducing blood sugar levels, improving patient-reported outcomes such as diabetes-related distress, and facilitating the implementation of these approaches in real-world primary care settings serving vulnerable populations. The findings intend to inform about optimal telehealth strategies for managing multiple chronic conditions in underserved groups, there by supporting improved health equity and quality of care.

Key Dates

First listed
Jun 24, 2025
Start date
Jul 6, 2026
Status verified
Jun 2026
Primary completion
Dec 1, 2027
Completion
Jan 31, 2028

Study Design

Enrollment
5,000 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Digital Health Coaching
    weekly coaching calls that address topics related to goal setting, creating supportive environments for behavior change, physical activity, and nutrition
  • Experimental: Remote Patient Monitoring
    Care coordinators within the RPM program will make individual contact with participants to discuss their plan and further educate on methods to manage their diabetes more efficiently.
  • Experimental: Combination of Digital Health Coaching and Remote Patient Monitoring
    Combination of Digital Health Coaching and Remote Patient Monitoring

Primary Outcome Measure

Change in Hemoglobin A1c [ Time Frame: 12 months ]

Central Contacts

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