Trials / Completed
CompletedNCT04927377
Accessible and Inclusive Diabetes Telecoaching Self-Management Program
Accessible and Inclusive Diabetes Telecoaching Self-Management Program: Protocol for a Feasibility Study
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 90 (actual)
- Sponsor
- University of Alabama at Birmingham · Academic / Other
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BEHAVIORAL | AI4DM | Those in the AI4DM intervention arm will receive weekly and bi-weekly calls for six months, access to home and online technology, diabetes-related multimedia educational content, a technology package including a voice-assistive device, wireless glucometer, and wrist-worn activity monitor |
| BEHAVIORAL | Attention-control | Those in the Attention-control Group will receive telecoaching calls at the same frequency of the Intervention Group. Coaching calls will focus on general wellbeing, rather than diabetes-related topics. The Attention-control Group will serve as an untreated comparison group for the Intervention Group. |
Timeline
- Start date
- 2022-10-31
- Primary completion
- 2025-09-30
- Completion
- 2025-09-30
- First posted
- 2021-06-16
- Last updated
- 2025-12-18
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT04927377. Inclusion in this directory is not an endorsement.