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

NCT07032844 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 5000

Last updated 2026-05-01

No results posted yet for this study

Summary

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.

Conditions

Interventions

BEHAVIORAL

Digital Health Coaching

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.

BEHAVIORAL

Phone Based Coaching

Weekly coaching calls that address topics related to goal setting, creating supportive environments for behavior change, physical activity, and nutrition.

BEHAVIORAL

Combination of Digital Health coaching + Remote Patient Monitoring

Combination of both digital health coaching and remote patient monitoring

Sponsors & Collaborators

  • Patient-Centered Outcomes Research Institute

    collaborator OTHER
  • University of Alabama at Birmingham

    lead OTHER

Principal Investigators

  • Tapan Mehta, PhD · University of Alabama at Birmingham

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
89 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-31
Primary Completion
2027-12-01
Completion
2028-01-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07032844 on ClinicalTrials.gov