An Accessible and Inclusive Artificial Intelligence Assisted Chronic Disease Self-Management Telehealth Platform

NCT05481593 | Completed

• 1 other identifier: IRB-300009485
• Study Type: interventional
• Target: 212
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study to pilot test an accessible and inclusive artificial intelligence (AI)-assisted, individualized, family-focused lifestyle modification intervention (AI4CHRON) for health-related quality of life for adults with impaired mobility and chronic medical conditions.

Conditions

Disability Physical; Chronic Condition; Chronic Conditions, Multiple

Outcome Measures

Primary Outcomes (1)

• Health-related quality-of-life

  Enabled version of Short-Form 36 (SF-36E)

  24 Weeks

Secondary Outcomes (17)

• Physical activity

  24 weeks

• Usability

  24 weeks

• Usability

  24 weeks

• Medication adherence

  24 weeks

• Medication adherence

  24 weeks

Study Arms (4)

Scheduled Coaching Calls & Gamified Rewards

EXPERIMENTAL

Behavioral: Scheduled Coaching + Gamified Rewards

No Scheduled Coaching Call & Gamified Rewards

EXPERIMENTAL

Behavioral: No Scheduled Coaching Calls + Gamified Rewards

Scheduled Coaching Calls & Independent rewards (No Gamification)

EXPERIMENTAL

Behavioral: Scheduled Coaching Calls + Independent Rewards

No Scheduled Coaching Calls & Independent Rewards (No Gamification)

EXPERIMENTAL

Behavioral: No Scheduled Coaching Calls + Independent rewards

Interventions

Scheduled Coaching + Gamified Rewards BEHAVIORAL

Participants will receive scheduled coaching calls and receive gamified rewards (i.e., earning points over time and converted to monetary gifts)

Scheduled Coaching Calls & Gamified Rewards

Scheduled Coaching Calls + Independent Rewards BEHAVIORAL

Participants will receive scheduled coaching calls and receive fixed rewards (i.e., non-increasing)

Scheduled Coaching Calls & Independent rewards (No Gamification)

No Scheduled Coaching Calls + Gamified Rewards BEHAVIORAL

Participants will not have scheduled coaching calls and receive gamified rewards (i.e., earning points over time and converted to monetary gifts)

No Scheduled Coaching Call & Gamified Rewards

No Scheduled Coaching Calls + Independent rewards BEHAVIORAL

Participants will not have scheduled coaching calls and receive fixed rewards (i.e., non-increasing)

No Scheduled Coaching Calls & Independent Rewards (No Gamification)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years or older
• Diagnosis of heart disease, chronic lung disease, or Type 2 diabetes
• Living with a permanent physical disability (i.e., spina bifida, multiple sclerosis, stroke,)
• Have the ability to converse in and read English
• Availability of a smartphone or computer

You may not qualify if:

• Current enrollment in any structured intervention
• Severe cognitive impairment
• Severe untreated depression in the past 6 months
• Major cardiac event in the past 12 months
• Uncontrolled blood pressure
• Resting tachycardia
• Renal failure
• Severe peripheral neuropathy
• Active treatment for cancer in the past 12 months
• Having both visual and hearing impairments (either of them is fine)

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

Related Publications (3)

• Evans E, Zengul A, Subhash Chilke T, Knight A, Willig A, Cherrington A, Mehta T, Thirumalai M. Telehealth Behavioral Intervention for Chronic Disease Self-Management in Adults With Physical Disabilities (My Health, My Life, My Way): Protocol for Intervention Fidelity and Dashboard Design for a Randomized Controlled Trial. JMIR Res Protoc. 2024 Feb 12;13:e53410. doi: 10.2196/53410.

  PMID: 38345845 DERIVED

• Evans E, Zengul A, Knight A, Willig A, Cherrington A, Mehta T, Thirumalai M. Stakeholders' Perspectives, Needs, and Barriers to Self-Management for People With Physical Disabilities Experiencing Chronic Conditions: Focus Group Study. JMIR Rehabil Assist Technol. 2023 Dec 18;10:e43309. doi: 10.2196/43309.

  PMID: 38109170 DERIVED

• Evans E, Zengul A, Knight A, Willig A, Cherrington A, Mehta T, Thirumalai M. My Health, My Life, My Way-An Inclusive Web-Based Self-management Program for People With Disabilities Living With Chronic Conditions: Protocol for a Multiphase Optimization Strategy Study. JMIR Res Protoc. 2023 Apr 28;12:e31694. doi: 10.2196/31694.

  PMID: 37115620 DERIVED

MeSH Terms

Conditions

Chronic Disease; Multiple Chronic Conditions

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 27, 2022
• First Posted: August 1, 2022
• Study Start: February 1, 2024
• Primary Completion: October 31, 2025
• Study Completion: October 31, 2025
• Last Updated: December 18, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ANALYTIC CODE

Locations

US (1)