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Purpose

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.

Conditions

Eligibility

Eligible Ages
Between 18 Years and 65 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Other
Masking
Double (Investigator, Outcomes Assessor)
Masking Description
The principal investigator and biostatistician will be masked to the randomization of the participants into the two treatment groups.

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
AI4DM Intervention Group
  • 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
Active Comparator
Attention-control Group
  • 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.

Recruiting Locations

University of Alabama at Birmingham
Birmingham 4049979, Alabama 4829764 35294
Contact:
Eric Evans, PhD
205-975-3270
evansej@uab.edu

More Details

Status
Recruiting
Sponsor
University of Alabama at Birmingham

Study Contact

Eric J Evans, PhD
205-934-7189
evansej@uab.edu

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.