Accessible and Inclusive Diabetes Telecoaching Self-Management Program

Not Applicable

Recruiting

• Conditions: Diabete Type 2; Disability Physical

• Registration Number: NCT04927377
• Lead Sponsor: University of Alabama at Birmingham

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.

Study Timeline

• Study First Submitted: 2021-06-04
• Study First Submitted QC: 2021-06-08
• Study First Posted: 2021-06-16
• Study Start: 2022-10-31
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-16
• Last Update Posted: 2024-10-18
• Primary Completion: 2025-09-30
• Study Completion: 2025-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 90

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Glycemic Management	48 weeks	Measured using HbA1c

Secondary Outcome Measures

Name	Time	Method
Family Support	48 weeks	Measured using the Diabetes Social Support Questionnaire - Family Version (DSSQ-Family); Minimum score = -5 maximum score = 15; Higher score represents better outcome
Medication Adherence	48 weeks	Measured using the Medication Adherence Rating Scale
Self-efficacy	48 weeks	Measured using Diabetes Empowerment Scale; Minimum score = 1; maximum score = 5; Higher score represents better outcome
Health Information Technology	48 weeks	Measured using The eHealth Literacy Scale
Telehealth Dashboard Usability	48 weeks	Measured using the System Usability Scale; Maximum item score (Strongly agree) = 5, minimum item score (Strongly disagree) = 1; Higher scores represent better outcomes
Health Technology Usability	48 weeks	Measured using the Health Information Usability Evaluation Scale (Health-ITUES)
Psychological distress	48 weeks	Measured using Diabetes Distress Scale (DDS); Minimum score = 1, maximum score = 6; Higher score represents worse outcome
Diabetes Quality of life	48 weeks	Measured using the DQoL (Diabetes Quality of Life Measure) Questionnaire; Minimum score =1; maximum score = 5; Higher score represents worse outcome
Physical Activity	48 weeks	Measured using Godin leisure-time exercise questionnaire; Minimum score = 0; Maximum score = unknown; Higher score represents better outcome
Dietary intake	48 weeks	Measured using The UK Diabetes and Diet Questionnaire

Trial Locations

Locations (1)

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States