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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AI4DM Intervention Group | Experimental |
| |
| Attention-control Group | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Glycemic Management | Measured using HbA1c | 48 weeks |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26647414 | Background | 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. | |
| 22232096 |
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Deidentified data will be submitted to ICPSR.
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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The principal investigator and biostatistician will be masked to the randomization of the participants into the two treatment groups.
|
| 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. |
|
| 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 |
| 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. |
| 12435261 | Background | 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. |
| 11769298 | Background | 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. |
| 34505835 | Derived | 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. |
| 34505831 | Derived | 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. |
| D004700 | Endocrine System Diseases |