Accessible and Inclusive Diabetes Telecoaching Self-Management Program

NCT04927377 | Completed

• 1 other identifier: IRB-300007168
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabete Type 2; Disability Physical

Outcome Measures

Primary Outcomes (1)

• Glycemic Management

  Measured using HbA1c

  48 weeks

Secondary Outcomes (10)

• Psychological distress

  48 weeks

• Diabetes Quality of life

  48 weeks

• Self-efficacy

  48 weeks

• Family Support

  48 weeks

• Physical Activity

  48 weeks

Study Arms (2)

AI4DM Intervention Group

EXPERIMENTAL

Behavioral: AI4DM

Attention-control Group

ACTIVE COMPARATOR

Behavioral: Attention-control

Interventions

AI4DM BEHAVIORAL

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

AI4DM Intervention Group

Attention-control BEHAVIORAL

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.

Attention-control Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

Related Publications (6)

• Wolff K, Chambers L, Bumol S, White RO, Gregory BP, Davis D, Rothman RL. The PRIDE (Partnership to Improve Diabetes Education) Toolkit: Development and Evaluation of Novel Literacy and Culturally Sensitive Diabetes Education Materials. Diabetes Educ. 2016 Feb;42(1):23-33. doi: 10.1177/0145721715620019. Epub 2015 Dec 7.

  PMID: 26647414 BACKGROUND

• Ali MK, Echouffo-Tcheugui J, Williamson DF. How effective were lifestyle interventions in real-world settings that were modeled on the Diabetes Prevention Program? Health Aff (Millwood). 2012 Jan;31(1):67-75. doi: 10.1377/hlthaff.2011.1009.

  PMID: 22232096 BACKGROUND

• Bodenheimer T, Lorig K, Holman H, Grumbach K. Patient self-management of chronic disease in primary care. JAMA. 2002 Nov 20;288(19):2469-75. doi: 10.1001/jama.288.19.2469.

  PMID: 12435261 BACKGROUND

• Lorig KR, Sobel DS, Ritter PL, Laurent D, Hobbs M. Effect of a self-management program on patients with chronic disease. Eff Clin Pract. 2001 Nov-Dec;4(6):256-62.

  PMID: 11769298 BACKGROUND

• Zengul A, Evans E, Hall A, Qu H, Willig A, Cherrington A, Thirumalai M. Telehealth Behavioral Intervention for Diabetes Management in Adults With Physical Disabilities: Intervention Fidelity Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2021 Sep 10;10(9):e31695. doi: 10.2196/31695.

  PMID: 34505835 DERIVED

• Evans E, Zengul A, Hall A, Qu H, Willig A, Cherrington A, Thirumalai M. Disability-Inclusive Diabetes Self-management Telehealth Program: Protocol for a Pilot and Feasibility Study. JMIR Res Protoc. 2021 Sep 10;10(9):e31689. doi: 10.2196/31689.

  PMID: 34505831 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The principal investigator and biostatistician will be masked to the randomization of the participants into the two treatment groups.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: June 4, 2021
• First Posted: June 16, 2021
• Study Start: October 31, 2022
• Primary Completion: September 30, 2025
• Study Completion: September 30, 2025
• Last Updated: December 18, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ANALYTIC CODE

Locations

US (1)