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

NCT ID: NCT05481593

Last Updated: 2025-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

212 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-01

Study Completion Date

2025-10-31

Brief Summary

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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.

Detailed Description

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The AI4CHRON study will use a four-arm randomized control trial design. Eligible and consented participants will be assigned to one of four groups: 1) Scheduled coaching calls with gamified rewards, 2) Scheduled coaching calls with rewards independent of gamification, 3) No scheduled coaching calls with gamified rewards, and 4) No scheduled coaching calls with rewards independent of gamification. The active intervention period will be six months.

Conditions

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Disability Physical Chronic Condition Chronic Conditions, Multiple

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Scheduled Coaching Calls & Gamified Rewards

Group Type EXPERIMENTAL

Scheduled Coaching + Gamified Rewards

Intervention Type BEHAVIORAL

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

No Scheduled Coaching Call & Gamified Rewards

Group Type EXPERIMENTAL

No Scheduled Coaching Calls + Gamified Rewards

Intervention Type BEHAVIORAL

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

Scheduled Coaching Calls & Independent rewards (No Gamification)

Group Type EXPERIMENTAL

Scheduled Coaching Calls + Independent Rewards

Intervention Type BEHAVIORAL

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

No Scheduled Coaching Calls & Independent Rewards (No Gamification)

Group Type EXPERIMENTAL

No Scheduled Coaching Calls + Independent rewards

Intervention Type BEHAVIORAL

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

Interventions

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Scheduled Coaching + Gamified Rewards

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

Intervention Type BEHAVIORAL

Scheduled Coaching Calls + Independent Rewards

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

Intervention Type BEHAVIORAL

No Scheduled Coaching Calls + Gamified Rewards

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

Intervention Type BEHAVIORAL

No Scheduled Coaching Calls + Independent rewards

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 18 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

Exclusion Criteria

* 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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Alabama at Birmingham

OTHER

Sponsor Role lead

Responsible Party

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Mohanraj Thirumalai

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Alabama at Birmingham

Birmingham, Alabama, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 38345845 (View on PubMed)

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.

Reference Type DERIVED
PMID: 38109170 (View on PubMed)

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.

Reference Type DERIVED
PMID: 37115620 (View on PubMed)

Other Identifiers

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IRB-300009485

Identifier Type: -

Identifier Source: org_study_id