Accessible and Inclusive Diabetes Telecoaching Self-Management Program

The University of Alabama at Birmingham

Status: Completed

Conditions: Disability Physical; Diabete Type 2

Treatments: Behavioral: Attention-control; Behavioral: AI4DM

Study type: Interventional

Funder types: Other

Identifiers

NCT04927377

IRB-300007168

Details and patient eligibility

About

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.

Full 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.

Enrollment: 90 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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90 participants in 2 patient groups

AI4DM Intervention Group

Experimental group

Treatment:

Behavioral: AI4DM

Attention-control Group

Active Comparator group

Treatment:

Behavioral: Attention-control