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

December 11, 2025 updated by: Mohanraj Thirumalai, University of Alabama at Birmingham

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
212

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Eric J Evans, PhD
  • Phone Number: 205-934-7189
  • Email: evansej@uab.edu

Study Contact Backup

  • Name: Mohanraj Thirumalai, PhD
  • Phone Number: 205-934-7189
  • Email: mohanraj@uab.edu

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • University of Alabama at Birmingham

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Scheduled Coaching Calls & Gamified Rewards
Behavioral: 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)
Experimental: No Scheduled Coaching Call & Gamified Rewards
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)
Experimental: Scheduled Coaching Calls & Independent rewards (No Gamification)
Behavioral: Scheduled Coaching Calls + Independent Rewards
Participants will receive scheduled coaching calls and receive fixed rewards (i.e., non-increasing)
Experimental: No Scheduled Coaching Calls & Independent Rewards (No Gamification)
Behavioral: No Scheduled Coaching Calls + Independent rewards
Participants will not have scheduled coaching calls and receive fixed rewards (i.e., non-increasing)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Health-related quality-of-life
Time Frame: 24 Weeks
Enabled version of Short-Form 36 (SF-36E)
24 Weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Physical activity
Time Frame: 24 weeks
Godin leisure time exercise questionnaire
24 weeks
Usability
Time Frame: 24 weeks
System Usability Scale
24 weeks
Usability
Time Frame: 24 weeks
Health Information Technology Usability Evaluation Scale
24 weeks
Medication adherence
Time Frame: 24 weeks
Medication adherence rating scale
24 weeks
Medication adherence
Time Frame: 24 weeks
Turnkey Adherence Strategy Medication Adherence
24 weeks
Self-efficacy for managing depression
Time Frame: 24 weeks
PROMIS SF v1.0 Emotional Distress-Depression 4a
24 weeks
Self-efficacy for managing psychosocial illness
Time Frame: 24 weeks
PROMIS SF v1.0 Psychosocial illness impact 8a
24 weeks
Self-efficacy for managing emotions
Time Frame: 24 weeks
PROMIS SF v1.0 Managing Emotions 4a
24 weeks
Self-efficacy for managing medications
Time Frame: 24 weeks
PROMIS SF v1.0 Managing Emotions 4a
24 weeks
Self-efficacy for managing social interactions
Time Frame: 24 weeks
PROMIS SF v1.0 Social Interactions 4a
24 weeks
Physical Activity
Time Frame: 24 weeks
Measured via data from FitBit device (Minutes)
24 weeks
Physical Activity
Time Frame: 24 weeks
Measured via data from FitBit device (Steps)
24 weeks
Self-efficacy for managing symptoms
Time Frame: 24 weeks
PROMIS SF v1.0 Managing Symptoms 4a
24 weeks
Self-efficacy for managing daily activities
Time Frame: 24 weeks
PROMIS SF v1.0 Managing daily activities 4a
24 weeks
Self-efficacy for managing sleep disturbance
Time Frame: 24 weeks
PROMIS SF v1.0 Sleep Disturbance 4a
24 weeks
Self-efficacy for managing sleep-related impairments
Time Frame: 24 weeks
PROMIS SF v1.0 Sleep-related impairment
24 weeks
Dietary Intake
Time Frame: 24 weeks
Short Healthy Eating Index
24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Alabama at Birmingham

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 31, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 31, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 27, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 28, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 1, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 18, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 11, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IRB-300009485

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Supporting Information Type

  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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