Accessible and Inclusive Diabetes Telecoaching Self-Management Program

Accessible and Inclusive Diabetes Telecoaching Self-Management Program: Protocol for a Feasibility Study

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.

Study Overview

• Status: Completed
• Conditions: Disability Physical; Diabete Type 2
• Intervention / Treatment: Behavioral: AI4DM; Behavioral: Attention-control

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.

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • University of Alabama at Birmingham

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Glycemic Management	Measured using HbA1c	48 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Psychological distress	Measured using Diabetes Distress Scale (DDS); Minimum score = 1, maximum score = 6; Higher score represents worse outcome	48 weeks
Diabetes Quality of life	Measured using the DQoL (Diabetes Quality of Life Measure) Questionnaire; Minimum score =1; maximum score = 5; Higher score represents worse outcome	48 weeks
Self-efficacy	Measured using Diabetes Empowerment Scale; Minimum score = 1; maximum score = 5; Higher score represents better outcome	48 weeks
Family Support	Measured using the Diabetes Social Support Questionnaire - Family Version (DSSQ-Family); Minimum score = -5 maximum score = 15; Higher score represents better outcome	48 weeks
Physical Activity	Measured using Godin leisure-time exercise questionnaire; Minimum score = 0; Maximum score = unknown; Higher score represents better outcome	48 weeks
Dietary intake	Measured using The UK Diabetes and Diet Questionnaire	48 weeks
Medication Adherence	Measured using the Medication Adherence Rating Scale	48 weeks
Health Information Technology	Measured using The eHealth Literacy Scale	48 weeks
Telehealth Dashboard Usability	Measured using the System Usability Scale; Maximum item score (Strongly agree) = 5, minimum item score (Strongly disagree) = 1; Higher scores represent better outcomes	48 weeks
Health Technology Usability	Measured using the Health Information Usability Evaluation Scale (Health-ITUES)	48 weeks

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 31, 2022
• Primary Completion (Actual): September 30, 2025
• Study Completion (Actual): September 30, 2025

Study Registration Dates

• First Submitted: June 4, 2021
• First Submitted That Met QC Criteria: June 8, 2021
• First Posted (Actual): June 16, 2021

Study Record Updates

• Last Update Posted (Estimated): December 18, 2025
• Last Update Submitted That Met QC Criteria: December 11, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Nutritional and Metabolic Diseases; Diabetes Mellitus, Type 2
• Other Study ID Numbers: IRB-300007168

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Deidentified data will be submitted to ICPSR.
• IPD Sharing Supporting Information Type: ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No