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

NCT07032844 | Not Yet Recruiting

• 2 other identifiers: IRB-300014522TE-2023C3-34949
• Study Type: interventional
• Target: 5,000
• Locations: 0 countries
• Sites: N/A

Brief 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

Type 2 Diabetes

Keywords

Diabetes

Outcome Measures

Primary Outcomes (1)

• Change in Hemoglobin A1c

  Our primary aim 1 compares the average treatment effectiveness of a six-month RPM, digital health coaching, and combination digital health coaching and RPM program through a multi-site pragmatic randomized trial design. Our primary outcome is reduction in HbA1c at 12 months. Investigators hypothesize that the combination arm will result in superior improvements in HbA1c compared to either intervention alone, aligning with preliminary stakeholder engagement suggesting patient-centered preference for this combined approach.

  12 months

Secondary Outcomes (1)

• Diabetes Distress Screening Scale Results

  12 months

Other Outcomes (2)

• Understand for Whom each intervention is more effective

  12 months

• Identify the contextual factors that affect implementation of the different intervention components.

  12 months

Study Arms (3)

Digital Health Coaching

EXPERIMENTAL

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

Behavioral: Digital Health Coaching

Remote Patient Monitoring

EXPERIMENTAL

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.

Behavioral: Phone Based Coaching

Combination of Digital Health Coaching and Remote Patient Monitoring

EXPERIMENTAL

Combination of Digital Health Coaching and Remote Patient Monitoring

Behavioral: Combination of Digital Health coaching + Remote Patient Monitoring

Interventions

Phone Based Coaching BEHAVIORAL

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

Remote Patient Monitoring

Combination of Digital Health coaching + Remote Patient Monitoring BEHAVIORAL

Combination of both digital health coaching and remote patient monitoring

Combination of Digital Health Coaching and Remote Patient Monitoring

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.

Digital Health Coaching

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Physical Disability
• Diagnosed with Type 2 Diabetes
• Hemoglobin A1c ≥7% within 3 months of screening
• Must have at least 1 additional chronic conditions from the list below Hypertension Congestive Heart Failure Coronary Artery Disease Hyperlipidemia Stroke Arthritis Asthma Cancer Chronic Kidney Disease (Stages 1-4) COPD Osteoporosis Multiple Sclerosis Parkinsons

You may not qualify if:

• Intellectual, Learning, Developmental Disabilities
• Non-english speakers
• Currently pregnant
• Significant vision loss preventing use of phone/tablet for interventions
• Received Remote Patient Monitoring or Digital Health Coaching for T2DM management within 30 days of enrollment
• End-stage kidney disease (on dialysis)
• Does not report having a physical disability
• Perceived unwillingness or inability to participate

Sponsors & Collaborators

• Patient-Centered Outcomes Research Institute: collaborator
• University of Alabama at Birmingham: lead

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus

Interventions

Remote Patient Monitoring

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Telemedicine; Delivery of Health Care; Patient Care Management; Health Services Administration

Study Officials

• Tapan Mehta, PhD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Aseel El Zein, PhD

CONTACT

205-975-9171; assilelzein@uabmc.edu

Rebekah Kummer, MS

CONTACT

205-975-9171; rebekahkummer@uabmc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: All participants enrolled in the study will receive one of the core interventions: 1. Digital Health coaching 2. Remote Patient Monitoring 3. Combination of Digital Health coaching + Remote Patient Monitoring

Study Record Dates

• First Submitted: June 7, 2025
• First Posted: June 24, 2025
• Study Start: May 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): January 31, 2028
• Last Updated: May 1, 2026

Record last verified: 2026-04