ClinicalTrials.gg
CompletedNCT05481593Updated Dec 18, 2025

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

An interventional study of Scheduled Coaching + Gamified Rewards and Scheduled Coaching Calls + Independent Rewards in Disability Physical, Chronic Condition and Chronic Conditions, Multiple, sponsored by University of Alabama at Birmingham. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-18.

Primary conditionMultiple Chronic ConditionsRegistry: Chronic DiseaseReclassifiedWhy we changed it
Registry
Chronic Disease — the first condition term the registry derived for this study.
ClinicalTrials.gg
Multiple Chronic Conditions
Why
  1. Chronic Disease is a broad heading, used only when no more specific condition is named.
  2. The study's listed conditions name Multiple Chronic Conditions, a narrower term within Chronic Disease.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by University of Alabama at Birmingham · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
212
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed description

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.

02

Conditions studied

  • Disability Physical
  • Chronic Condition
  • Chronic Conditions, Multiple

Browse trials for

03

In context

Multiple Chronic Conditions Reclassified

89 studies on the registry are indexed under Multiple Chronic Conditions; 16 are open to participants now.

This study's enrollment of 212 is above the median of 128 across 71 interventional studies indexed under Multiple Chronic Conditions.

Browse Multiple Chronic Conditions studies →

Lead sponsor

University of Alabama at Birmingham is the lead sponsor of 1,421 studies on the registry; 277 are open to participants now.

Of its 164 completed or terminated interventional studies of FDA-regulated products, 130 (79%) have results posted.

Compared within Multiple Chronic Conditions, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Chronic Disease. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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)
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
212 participants (actual)

Study arms

  • Experimental
    Scheduled Coaching Calls & Gamified Rewards

    Behavioral: Scheduled Coaching + Gamified Rewards

  • Experimental
    No Scheduled Coaching Call & Gamified Rewards

    Behavioral: No Scheduled Coaching Calls + Gamified Rewards

  • Experimental
    Scheduled Coaching Calls & Independent rewards (No Gamification)

    Behavioral: Scheduled Coaching Calls + Independent Rewards

  • Experimental
    No Scheduled Coaching Calls & Independent Rewards (No Gamification)

    Behavioral: No Scheduled Coaching Calls + Independent rewards

Interventions

  • BehavioralScheduled Coaching + Gamified Rewards

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

  • BehavioralScheduled Coaching Calls + Independent Rewards

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

  • BehavioralNo 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)

  • BehavioralNo Scheduled Coaching Calls + Independent rewards

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

06

What researchers measure

Primary outcomes

  1. Health-related quality-of-life

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

    Time frame: 24 Weeks

Secondary outcomes

  1. Physical activity

    Godin leisure time exercise questionnaire

    Time frame: 24 weeks

  2. Usability

    System Usability Scale

    Time frame: 24 weeks

  3. Usability

    Health Information Technology Usability Evaluation Scale

    Time frame: 24 weeks

  4. Medication adherence

    Medication adherence rating scale

    Time frame: 24 weeks

  5. Medication adherence

    Turnkey Adherence Strategy Medication Adherence

    Time frame: 24 weeks

  6. Self-efficacy for managing depression

    PROMIS SF v1.0 Emotional Distress-Depression 4a

    Time frame: 24 weeks

  7. Self-efficacy for managing psychosocial illness

    PROMIS SF v1.0 Psychosocial illness impact 8a

    Time frame: 24 weeks

  8. Self-efficacy for managing emotions

    PROMIS SF v1.0 Managing Emotions 4a

    Time frame: 24 weeks

  9. Self-efficacy for managing medications

    PROMIS SF v1.0 Managing Emotions 4a

    Time frame: 24 weeks

  10. Self-efficacy for managing social interactions

    PROMIS SF v1.0 Social Interactions 4a

    Time frame: 24 weeks

  11. Physical Activity

    Measured via data from FitBit device (Minutes)

    Time frame: 24 weeks

  12. Physical Activity

    Measured via data from FitBit device (Steps)

    Time frame: 24 weeks

  13. Self-efficacy for managing symptoms

    PROMIS SF v1.0 Managing Symptoms 4a

    Time frame: 24 weeks

  14. Self-efficacy for managing daily activities

    PROMIS SF v1.0 Managing daily activities 4a

    Time frame: 24 weeks

  15. Self-efficacy for managing sleep disturbance

    PROMIS SF v1.0 Sleep Disturbance 4a

    Time frame: 24 weeks

  16. Self-efficacy for managing sleep-related impairments

    PROMIS SF v1.0 Sleep-related impairment

    Time frame: 24 weeks

  17. Dietary Intake

    Short Healthy Eating Index

    Time frame: 24 weeks

07

Study locations

1 site
  • University of Alabama at Birmingham
    Birmingham, Alabama 35294, United States
08

References and documents

Publications

  • 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. PubMed 38345845 ↗
  • 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. PubMed 38109170 ↗
  • 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. PubMed 37115620 ↗

Individual participant data

Plan to share: Yes

Supporting information: Analytic code

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 18, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05481593
Responsible party
Mohanraj Thirumalai (Assistant Professor, University of Alabama at Birmingham) — Principal investigator
First posted
Aug 1, 2022
Start date
Feb 1, 2024
Primary completion
Oct 31, 2025
Completion
Oct 31, 2025
Last update
Dec 18, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.

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