Clinical trial NCT04927377: Accessible and Inclusive Diabetes Telecoaching Self-Management Program
Official title: Accessible and Inclusive Diabetes Telecoaching Self-Management Program: Protocol for a Feasibility Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Diabete Type 2
Disability Physical
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2021-06-16
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Glycemic Management
timeFrame: 48 weeks
Secondary outcomes:
measure: Psychological distress
timeFrame: 48 weeks
measure: Diabetes Quality of life
timeFrame: 48 weeks
measure: Self-efficacy
timeFrame: 48 weeks
measure: Family Support
timeFrame: 48 weeks
measure: Physical Activity
timeFrame: 48 weeks
measure: Dietary intake
timeFrame: 48 weeks
measure: Medication Adherence
timeFrame: 48 weeks
measure: Health Information Technology
timeFrame: 48 weeks
measure: Telehealth Dashboard Usability
timeFrame: 48 weeks
measure: Health Technology Usability
timeFrame: 48 weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.