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Accessible and Inclusive Diabetes Telecoaching Self-Management Program

Primary Purpose

Diabete Type 2, Disability Physical

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
AI4DM
Attention-control
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Diabete Type 2

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Alabama at BirminghamRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

AI4DM Intervention Group

Attention-control Group

Arm Description

Outcomes

Primary Outcome Measures

Glycemic Management
Measured using HbA1c

Secondary Outcome Measures

Psychological distress
Measured using Diabetes Distress Scale (DDS); Minimum score = 1, maximum score = 6; Higher score represents worse outcome
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
Self-efficacy
Measured using Diabetes Empowerment Scale; Minimum score = 1; maximum score = 5; Higher score represents better outcome
Family Support
Measured using the Diabetes Social Support Questionnaire - Family Version (DSSQ-Family); Minimum score = -5 maximum score = 15; Higher score represents better outcome
Physical Activity
Measured using Godin leisure-time exercise questionnaire; Minimum score = 0; Maximum score = unknown; Higher score represents better outcome
Dietary intake
Measured using The UK Diabetes and Diet Questionnaire
Medication Adherence
Measured using the Medication Adherence Rating Scale
Health Information Technology
Measured using The eHealth Literacy Scale
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
Health Technology Usability
Measured using the Health Information Usability Evaluation Scale (Health-ITUES)

Full Information

First Posted
June 4, 2021
Last Updated
March 14, 2023
Sponsor
University of Alabama at Birmingham
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1. Study Identification

Unique Protocol Identification Number
NCT04927377
Brief Title
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

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 31, 2022 (Actual)
Primary Completion Date
October 31, 2023 (Anticipated)
Study Completion Date
October 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabete Type 2, Disability Physical

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Masking Description
The principal investigator and biostatistician will be masked to the randomization of the participants into the two treatment groups.
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
AI4DM Intervention Group
Arm Type
Experimental
Arm Title
Attention-control Group
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
AI4DM
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
Attention-control
Intervention Description
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.
Primary Outcome Measure Information:
Title
Glycemic Management
Description
Measured using HbA1c
Time Frame
48 weeks
Secondary Outcome Measure Information:
Title
Psychological distress
Description
Measured using Diabetes Distress Scale (DDS); Minimum score = 1, maximum score = 6; Higher score represents worse outcome
Time Frame
48 weeks
Title
Diabetes Quality of life
Description
Measured using the DQoL (Diabetes Quality of Life Measure) Questionnaire; Minimum score =1; maximum score = 5; Higher score represents worse outcome
Time Frame
48 weeks
Title
Self-efficacy
Description
Measured using Diabetes Empowerment Scale; Minimum score = 1; maximum score = 5; Higher score represents better outcome
Time Frame
48 weeks
Title
Family Support
Description
Measured using the Diabetes Social Support Questionnaire - Family Version (DSSQ-Family); Minimum score = -5 maximum score = 15; Higher score represents better outcome
Time Frame
48 weeks
Title
Physical Activity
Description
Measured using Godin leisure-time exercise questionnaire; Minimum score = 0; Maximum score = unknown; Higher score represents better outcome
Time Frame
48 weeks
Title
Dietary intake
Description
Measured using The UK Diabetes and Diet Questionnaire
Time Frame
48 weeks
Title
Medication Adherence
Description
Measured using the Medication Adherence Rating Scale
Time Frame
48 weeks
Title
Health Information Technology
Description
Measured using The eHealth Literacy Scale
Time Frame
48 weeks
Title
Telehealth Dashboard Usability
Description
Measured using the System Usability Scale; Maximum item score (Strongly agree) = 5, minimum item score (Strongly disagree) = 1; Higher scores represent better outcomes
Time Frame
48 weeks
Title
Health Technology Usability
Description
Measured using the Health Information Usability Evaluation Scale (Health-ITUES)
Time Frame
48 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eric J Evans, PhD
Phone
205-934-7189
Email
evansej@uab.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Mohanraj Thirumalai, PhD
Phone
205-934-7189
Email
mohanraj@uab.edu
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eric Evans, PhD
Phone
205-975-3270
Email
evansej@uab.edu

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Deidentified data will be submitted to ICPSR.
Citations:
PubMed Identifier
26647414
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.
Results Reference
background
PubMed Identifier
22232096
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.
Results Reference
background
PubMed Identifier
12435261
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.
Results Reference
background
PubMed Identifier
11769298
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.
Results Reference
background
PubMed Identifier
34505835
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.
Results Reference
derived
PubMed Identifier
34505831
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.
Results Reference
derived

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Accessible and Inclusive Diabetes Telecoaching Self-Management Program

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