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Completed

NCT Number: NCT04927377

Accessible and Inclusive Diabetes Telecoaching Self-Management Program

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.

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Key information

Conditions

Diabete Type 2 Diabetes Mellitus Diabetes Mellitus, Type 2 Disability Physical Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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.

Primary outcomes

  1. Glycemic Management

    Time frame: 48 weeks

    Measured using HbA1c

Secondary outcomes

  1. Psychological distress

    Time frame: 48 weeks

    Measured using Diabetes Distress Scale (DDS); Minimum score = 1, maximum score = 6; Higher score represents worse outcome

  2. Diabetes Quality of life

    Time frame: 48 weeks

    Measured using the DQoL (Diabetes Quality of Life Measure) Questionnaire; Minimum score =1; maximum score = 5; Higher score represents worse outcome

  3. Self-efficacy

    Time frame: 48 weeks

    Measured using Diabetes Empowerment Scale; Minimum score = 1; maximum score = 5; Higher score represents better outcome

  4. Family Support

    Time frame: 48 weeks

    Measured using the Diabetes Social Support Questionnaire - Family Version (DSSQ-Family); Minimum score = -5 maximum score = 15; Higher score represents better outcome

  5. Physical Activity

    Time frame: 48 weeks

    Measured using Godin leisure-time exercise questionnaire; Minimum score = 0; Maximum score = unknown; Higher score represents better outcome

  6. Dietary intake

    Time frame: 48 weeks

    Measured using The UK Diabetes and Diet Questionnaire

  7. Medication Adherence

    Time frame: 48 weeks

    Measured using the Medication Adherence Rating Scale

  8. Health Information Technology

    Time frame: 48 weeks

    Measured using The eHealth Literacy Scale

  9. Telehealth Dashboard Usability

    Time frame: 48 weeks

    Measured using the System Usability Scale; Maximum item score (Strongly agree) = 5, minimum item score (Strongly disagree) = 1; Higher scores represent better outcomes

  10. Health Technology Usability

    Time frame: 48 weeks

    Measured using the Health Information Usability Evaluation Scale (Health-ITUES)

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Jun 16, 2021
Registry last updated
Dec 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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