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.
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
Intellectual, Learning, Developmental Disabilities
Non-english speakers
Currently pregnant
Significant vision loss preventing use of phone/tablet for interventions
Parallel
Digital Health Coaching
BehavioralThis 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.
Continuous Glucose Monitoring Teleconsults
BehavioralThis 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.
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.
Diabetes Distress Screening Scale Results
Investigators hypothesize that the combination arm will result in more significant improvements in diabetes distress compared to either the remote patient monitoring (RPM) or digital health coaching alone.
Understand for Whom each intervention is more effective
To conduct pre-specified and exploratory predictive modeling that explains the heterogeneity in treatment effects and helps us understand for whom either of these interventions is more effective.
Identify the contextual factors that affect implementation of the different intervention components.
A convergent, mixed methods approach rooted in the Consolidated Framework for Implementation Research (CFIR) will be used to assess the multifaceted, multilevel relationships among context, intervention implementation processes, and implementation outcomes. Implementation outcomes of the intervention will be evaluated by the reach, effectiveness, adoption, implementation, and maintenance (RE-AIM) framework.
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University of Alabama at Birmingham
Lead sponsor
Patient-Centered Outcomes Research Institute
Collaborator
