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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

TypeNameDescription
BEHAVIORALAI4DMThose 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
BEHAVIORALAttention-controlThose 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.

Accessible and Inclusive Diabetes Telecoaching Self-Management Program (NCT04927377) · Clinical Trials Directory