Advancing Diabetes Management for People With Physical Disabilities Optimally Through Primary Care-Based Telehealth (ADDOPT)
Comparing the Effectiveness of Primary Care Delivered Telehealth Interventions to Manage Type 2 Diabetes in People With Physical Disabilities and Multiple Chronic Conditions
2 other identifiers
interventional
5,000
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable type-2-diabetes
Started Sep 2026
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 7, 2025
CompletedFirst Posted
Study publicly available on registry
June 24, 2025
CompletedStudy Start
First participant enrolled
September 15, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2027
Study Completion
Last participant's last visit for all outcomes
January 31, 2028
July 30, 2026
July 1, 2026
1.2 years
June 7, 2025
July 28, 2026
Conditions
Keywords
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
EXPERIMENTALParticipants receive individual digital health coaching by phone: weekly calls for the first 12 weeks addressing goal setting, supportive environments for behavior change, physical activity, and nutrition, followed by biweekly calls for an additional 12 weeks (weeks 13-24) to reinforce habits and advance goals.
Continuous Glucose Monitoring Teleconsults
EXPERIMENTALParticipants receive continuous glucose monitoring (CGM) with periodic clinician teleconsults over 6 months. Study staff ship a CGM kit (sensor and reader, for participants without a compatible smartphone) to the participant's home; sensors are replaced per manufacturer guidelines. During onboarding, participants receive device education and safety counseling on recognizing and managing hypoglycemia (\<70 mg/dL; severe \<54 mg/dL) and hyperglycemia (\>300 mg/dL). During each teleconsult, the primary care team reviews Time in Range, Time Above Range, and Time Below Range, identifies patterns between glucose and lifestyle factors, and adjusts goals or medications as needed.
Combination of Digital Health Coaching and CGM-Teleconsults
EXPERIMENTALParticipants receive both digital health coaching and CGM-teleconsults in an integrated approach.
Interventions
This program will be developed using existing, evidence-based curricula for chronic disease self-management. 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.
In this arm, participants receive an integrated approach to diabetes management combining both digital health coaching and CGM-teleconsults, added in response to stakeholder and reviewer feedback expressing interest in benefiting from both interventions. Health coaches and CGM-trained team members work collaboratively to help participants set realistic goals and reinforce lifestyle strategies: the health coach evaluates the participant's food choices in relation to blood sugar patterns, while the CGM team reinforces the nutrition and physical activity recommendations set by the health coach during CGM teleconsults. Information flows bidirectionally - the CGM team informs the health coach of areas needing more emphasis, and the health coach flags participants who may need closer monitoring - so that each participant's care remains cohesive and adaptive to their glucose data and behavioral progress together.
This comparator arm consists of continuous glucose monitoring (CGM) with periodic teleconsult visits over 6 months, delivered by trained pharmacists, RDs, or nurses, with devices shipped centrally to participants' homes. Sensors are replaced per manufacturer guidelines. During onboarding, participants receive device education and standardized safety counseling on recognizing and managing hypoglycemia (\<70 mg/dL; severe \<54 mg/dL) and hyperglycemia (\>300 mg/dL), including when to seek urgent or emergency care. During each teleconsult, the CGM team reviews Time in Range, Time Above Range, and Time Below Range, identifies patterns between glucose and lifestyle factors, and supports goal setting and medication adjustments as needed. Participants with repeated missed readings are contacted by the study team to troubleshoot adherence barriers.
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
UAB Highlands Hospital/Department of Family and Community Medicine
Birmingham, Alabama, 35223, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Tapan Mehta, PhD
University of Alabama at Birmingham
Central Study Contacts
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
Study Record Dates
First Submitted
June 7, 2025
First Posted
June 24, 2025
Study Start (Estimated)
September 15, 2026
Primary Completion (Estimated)
December 1, 2027
Study Completion (Estimated)
January 31, 2028
Last Updated
July 30, 2026
Record last verified: 2026-07