Accessible and Inclusive Diabetes Telecoaching Self-Management Program

Disability Physical Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04927377
• Other study ID #: IRB-300007168
• Status: Recruiting
• Phase: N/A
• Start date: October 31, 2022
• Est. completion date: September 30, 2024

Study information

• Verified date: October 2023
• Source: University of Alabama at Birmingham
• Contact: Eric J Evans, PhD
• Phone: 205-934-7189
• Email: evansej[@]uab.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: September 30, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabete Type 2
• Diabetes Mellitus, Type 2
• Disability Physical

Intervention

Behavioral:
• AI4DM
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-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.

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glycemic Management	Measured using HbA1c	48 weeks
Secondary	Psychological distress	Measured using Diabetes Distress Scale (DDS); Minimum score = 1, maximum score = 6; Higher score represents worse outcome	48 weeks
Secondary	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
Secondary	Self-efficacy	Measured using Diabetes Empowerment Scale; Minimum score = 1; maximum score = 5; Higher score represents better outcome	48 weeks
Secondary	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
Secondary	Physical Activity	Measured using Godin leisure-time exercise questionnaire; Minimum score = 0; Maximum score = unknown; Higher score represents better outcome	48 weeks
Secondary	Dietary intake	Measured using The UK Diabetes and Diet Questionnaire	48 weeks
Secondary	Medication Adherence	Measured using the Medication Adherence Rating Scale	48 weeks
Secondary	Health Information Technology	Measured using The eHealth Literacy Scale	48 weeks
Secondary	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
Secondary	Health Technology Usability	Measured using the Health Information Usability Evaluation Scale (Health-ITUES)	48 weeks