Accessible and Inclusive Diabetes Telecoaching Self-Management Program

University of Alabama at Birmingham90 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

OTHER

Masking

DOUBLE

Enrollment

Conditions

Diabete Type 2 Disability Physical

Interventions

AI4DMBEHAVIORAL

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-controlBEHAVIORAL

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

University of Alabama at Birmingham

Birmingham, Alabama, United States

Outcomes

Primary Outcomes

Glycemic Management

Measured using HbA1c

Time frame: 48 weeks

Secondary Outcomes

Psychological distress

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

Time frame: 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

Time frame: 48 weeks

Self-efficacy

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

Time frame: 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

Time frame: 48 weeks

Physical Activity

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

Time frame: 48 weeks

Dietary intake

Measured using The UK Diabetes and Diet Questionnaire

Time frame: 48 weeks

Medication Adherence

Measured using the Medication Adherence Rating Scale

Data from ClinicalTrials.gov

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