Accessible and Inclusive Diabetes Telecoaching Self-Management Program: Protocol for a Feasibility Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Diabete Type 2
- Sponsor
- University of Alabama at Birmingham
- Enrollment
- 90
- Locations
- 1
- Primary Endpoint
- Glycemic Management
- Status
- Completed
- Last Updated
- 4 months ago
Overview
Brief Summary
The purpose of this study is to develop and pilot test an accessible and inclusive Artificial Intelligence (AI)-assisted, individualized, family-focused lifestyle modification intervention (AI4DM) for glycemic control in people with disabilities.
Detailed Description
The AI4DM study will use a two-arm randomized control trial design. Eligible and consented participants will be assigned to one of two groups: 1) AI4DM intervention group with telecoaching support, and 2) attention-control group. The active intervention period will include six months of weekly and bi-weekly telecoaching calls followed by six months of follow-up and technology access, but no telecoaching calls.
Investigators
Mohanraj Thirumalai
Assistant Professor
University of Alabama at Birmingham
Eligibility Criteria
Inclusion Criteria
- •Diagnosis of Type 2 Diabetes Mellitus,
- •Living with a permanent physical disability such as spinal cord injury (SCI), spina bifida, multiple sclerosis, stroke, etc.
- •Ability to converse and read in English
Exclusion Criteria
- •Current enrollment in any diabetes-related intervention
- •Severe untreated depression in the past six months
- •Major cardiac event in the past twelve months
- •Uncontrolled blood pressure
- •Resting tachycardia
- •Renal failure
- •Severe peripheral neuropathy
- •Unavailability of a smartphone
Outcomes
Primary Outcomes
Glycemic Management
Time Frame: 48 weeks
Measured using HbA1c
Secondary Outcomes
- Family Support(48 weeks)
- Medication Adherence(48 weeks)
- Self-efficacy(48 weeks)
- Health Information Technology(48 weeks)
- Telehealth Dashboard Usability(48 weeks)
- Health Technology Usability(48 weeks)
- Psychological distress(48 weeks)
- Diabetes Quality of life(48 weeks)
- Physical Activity(48 weeks)
- Dietary intake(48 weeks)