Diabete Type 2, Disability Physical
Conditions
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.
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.
Interventions
BEHAVIORALAI4DM
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
BEHAVIORALAttention-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.
Sponsors
University of Alabama at Birmingham
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
The principal investigator and biostatistician will be masked to the randomization of the participants into the two treatment groups.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Glycemic Management | 48 weeks | Measured using HbA1c |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Diabetes Quality of life | 48 weeks | Measured using the DQoL (Diabetes Quality of Life Measure) Questionnaire; Minimum score =1; maximum score = 5; Higher score represents worse outcome |
| Self-efficacy | 48 weeks | Measured using Diabetes Empowerment Scale; Minimum score = 1; maximum score = 5; Higher score represents better outcome |
| Family Support | 48 weeks | Measured using the Diabetes Social Support Questionnaire - Family Version (DSSQ-Family); Minimum score = -5 maximum score = 15; Higher score represents better outcome |
| Physical Activity | 48 weeks | Measured using Godin leisure-time exercise questionnaire; Minimum score = 0; Maximum score = unknown; Higher score represents better outcome |
| Psychological distress | 48 weeks | Measured using Diabetes Distress Scale (DDS); Minimum score = 1, maximum score = 6; Higher score represents worse outcome |
| Medication Adherence | 48 weeks | Measured using the Medication Adherence Rating Scale |
| Health Information Technology | 48 weeks | Measured using The eHealth Literacy Scale |
| Telehealth Dashboard Usability | 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 |
| Health Technology Usability | 48 weeks | Measured using the Health Information Usability Evaluation Scale (Health-ITUES) |
| Dietary intake | 48 weeks | Measured using The UK Diabetes and Diet Questionnaire |
Countries
United States
Outcome results
None listed