Disability PhysicalNCT05481593
An Accessible and Inclusive Artificial Intelligence Assisted Chronic Disease Self-Management Telehealth Platform
A study testing Scheduled Coaching + Gamified Rewards, Scheduled Coaching Calls + Independent Rewards and No Scheduled Coaching Calls + Gamified Rewards in people with Disability Physical and Chronic Condition, run by University of Alabama at Birmingham at 1 site in United States.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Disability Physical, Chronic Condition, Chronic Conditions, Multiple
- What is being tested?
- Scheduled Coaching + Gamified Rewards, Scheduled Coaching Calls + Independent Rewards and No Scheduled Coaching Calls + Gamified Rewards
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 212 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2024to 31 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama at Birmingham
Birmingham, Alabama, 35294
About this study
Official title: An Accessible and Inclusive Artificial Intelligence Assisted Chronic Disease Self-Management Telehealth Platform: A Pilot Study
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.
- Being tested
- Scheduled Coaching + Gamified Rewards, Scheduled Coaching Calls + Independent Rewards, No Scheduled Coaching Calls + Gamified Rewards, No Scheduled Coaching Calls + Independent rewards
- Medical subject headings
- Chronic Disease, Multiple Chronic Conditions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Scheduled Coaching + Gamified RewardsBehavioural
Participants will receive scheduled coaching calls and receive gamified rewards (i.e., earning points over time and converted to monetary gifts)
Scheduled Coaching Calls + Independent RewardsBehavioural
Participants will receive scheduled coaching calls and receive fixed rewards (i.e., non-increasing)
No Scheduled Coaching Calls + Gamified RewardsBehavioural
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 Calls + Independent rewardsBehavioural
Participants will not have scheduled coaching calls and receive fixed rewards (i.e., non-increasing)
| Study group | Role | What they receive |
|---|---|---|
| Scheduled Coaching Calls & Gamified Rewards | Experimental | Not described Receives: Behavioral: Scheduled Coaching + Gamified Rewards |
| No Scheduled Coaching Call & Gamified Rewards | Experimental | Not described Receives: Behavioral: No Scheduled Coaching Calls + Gamified Rewards |
| Scheduled Coaching Calls & Independent rewards (No Gamification) | Experimental | Not described Receives: Behavioral: Scheduled Coaching Calls + Independent Rewards |
| No Scheduled Coaching Calls & Independent Rewards (No Gamification) | Experimental | Not described Receives: Behavioral: No Scheduled Coaching Calls + Independent rewards |
What is being measured
The primary outcome is the main question the study is designed to answer.
Health-related quality-of-life
Enabled version of Short-Form 36 (SF-36E)
Measured: 24 Weeks
Secondary outcomes (17)
Physical activity
Godin leisure time exercise questionnaire
Measured: 24 weeks
Usability
System Usability Scale
Measured: 24 weeks
Usability
Health Information Technology Usability Evaluation Scale
Measured: 24 weeks
Medication adherence
Medication adherence rating scale
Measured: 24 weeks
Medication adherence
Turnkey Adherence Strategy Medication Adherence
Measured: 24 weeks
Self-efficacy for managing depression
PROMIS SF v1.0 Emotional Distress-Depression 4a
Measured: 24 weeks
Self-efficacy for managing psychosocial illness
PROMIS SF v1.0 Psychosocial illness impact 8a
Measured: 24 weeks
Self-efficacy for managing emotions
PROMIS SF v1.0 Managing Emotions 4a
Measured: 24 weeks
Self-efficacy for managing medications
PROMIS SF v1.0 Managing Emotions 4a
Measured: 24 weeks
Self-efficacy for managing social interactions
PROMIS SF v1.0 Social Interactions 4a
Measured: 24 weeks
Physical Activity
Measured via data from FitBit device (Minutes)
Measured: 24 weeks
Physical Activity
Measured via data from FitBit device (Steps)
Measured: 24 weeks
Self-efficacy for managing symptoms
PROMIS SF v1.0 Managing Symptoms 4a
Measured: 24 weeks
Self-efficacy for managing daily activities
PROMIS SF v1.0 Managing daily activities 4a
Measured: 24 weeks
Self-efficacy for managing sleep disturbance
PROMIS SF v1.0 Sleep Disturbance 4a
Measured: 24 weeks
Self-efficacy for managing sleep-related impairments
PROMIS SF v1.0 Sleep-related impairment
Measured: 24 weeks
Dietary Intake
Short Healthy Eating Index
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2022
- Study start1 Feb 2024
- Primary completion31 Oct 2025
- Study completion31 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Disability PhysicalStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 212 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohanraj Thirumalai, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05481593
- Sponsor's protocol ID
- IRB-300009485
- Status last verified
- Dec 2025
- First submitted
- 27 Jul 2022
- Last updated
- 18 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
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 38345845Evans 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 38109170Evans 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
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Accessible and Inclusive Artificial Intelligence Assisted Chronic Disease Self-Management Telehealth Platform: A Pilot Study
- ClinicalTrials.gov ID
- NCT05481593
- Acronym / sponsor ID
- IRB-300009485
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 212 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 31 Oct 2025 (actual)
- Study completion
- 31 Oct 2025 (actual)
- First posted
- 1 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Scheduled Coaching + Gamified RewardsParticipants will receive scheduled coaching calls and receive gamified rewards (i.e., earning points over time and converted to monetary gifts) | Behavioural | Scheduled Coaching Calls & Gamified Rewards |
| Scheduled Coaching Calls + Independent RewardsParticipants will receive scheduled coaching calls and receive fixed rewards (i.e., non-increasing) | Behavioural | Scheduled Coaching Calls & Independent rewards (No Gamification) |
| No Scheduled Coaching Calls + Gamified RewardsParticipants will not have scheduled coaching calls and receive gamified rewards (i.e., earning points over time and converted to monetary gifts) | Behavioural | No Scheduled Coaching Call & Gamified Rewards |
| No Scheduled Coaching Calls + Independent rewardsParticipants will not have scheduled coaching calls and receive fixed rewards (i.e., non-increasing) | Behavioural | No Scheduled Coaching Calls & Independent Rewards (No Gamification) |
Primary outcome
Health-related quality-of-life
Time frame: 24 Weeks
Enabled version of Short-Form 36 (SF-36E)
17 secondary outcomes
Physical activity
Time frame: 24 weeks
Usability
Time frame: 24 weeks
Usability
Time frame: 24 weeks
Medication adherence
Time frame: 24 weeks
Medication adherence
Time frame: 24 weeks
Self-efficacy for managing depression
Time frame: 24 weeks
Self-efficacy for managing psychosocial illness
Time frame: 24 weeks
Self-efficacy for managing emotions
Time frame: 24 weeks
Self-efficacy for managing medications
Time frame: 24 weeks
Self-efficacy for managing social interactions
Time frame: 24 weeks
Physical Activity
Time frame: 24 weeks
Physical Activity
Time frame: 24 weeks
Self-efficacy for managing symptoms
Time frame: 24 weeks
Self-efficacy for managing daily activities
Time frame: 24 weeks
Self-efficacy for managing sleep disturbance
Time frame: 24 weeks
Self-efficacy for managing sleep-related impairments
Time frame: 24 weeks
Dietary Intake
Time frame: 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2025.
- Derived from this study: PubMed 38345845Evans 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.
- Derived from this study: PubMed 38109170Evans 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.
- Derived from this study: PubMed 37115620Evans 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.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Scheduled Coaching + Gamified Rewards, Scheduled Coaching Calls + Independent Rewards and No Scheduled Coaching Calls + Gamified Rewards in people with Disability Physical and Chronic Condition, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Health-related quality-of-life (time frame: 24 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05481593, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2025.