Accessible and Inclusive Diabetes Telecoaching Self-Management Program

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Diabete Type 2, Disability Physical

Intervention / Treatment
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* Behavioral: AI4DM
* Behavioral: Attention-control


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AI4DM Intervention Group<br> | Behavioral: AI4DM<br>* 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<br>|
| Active Comparator: Attention-control Group<br> | Behavioral: Attention-control<br>* 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.<br>|

What is the study measuring?
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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 |