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OpenTrials
Completed

NCT Number: NCT05481593

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

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.

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Key information

Conditions

Disability Physical Chronic Condition Chronic Conditions, Multiple Chronic Disease Disease Attributes Multiple Chronic Conditions Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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 + Independent Rewards

Behavioral

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

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 Calls + Independent rewards

Behavioral

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

Primary outcomes

  1. Health-related quality-of-life

    Time frame: 24 Weeks

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

Secondary outcomes

  1. Physical activity

    Time frame: 24 weeks

    Godin leisure time exercise questionnaire

  2. Usability

    Time frame: 24 weeks

    System Usability Scale

  3. Usability

    Time frame: 24 weeks

    Health Information Technology Usability Evaluation Scale

  4. Medication adherence

    Time frame: 24 weeks

    Medication adherence rating scale

  5. Medication adherence

    Time frame: 24 weeks

    Turnkey Adherence Strategy Medication Adherence

  6. Self-efficacy for managing depression

    Time frame: 24 weeks

    PROMIS SF v1.0 Emotional Distress-Depression 4a

  7. Self-efficacy for managing psychosocial illness

    Time frame: 24 weeks

    PROMIS SF v1.0 Psychosocial illness impact 8a

  8. Self-efficacy for managing emotions

    Time frame: 24 weeks

    PROMIS SF v1.0 Managing Emotions 4a

  9. Self-efficacy for managing medications

    Time frame: 24 weeks

    PROMIS SF v1.0 Managing Emotions 4a

  10. Self-efficacy for managing social interactions

    Time frame: 24 weeks

    PROMIS SF v1.0 Social Interactions 4a

  11. Physical Activity

    Time frame: 24 weeks

    Measured via data from FitBit device (Minutes)

  12. Physical Activity

    Time frame: 24 weeks

    Measured via data from FitBit device (Steps)

  13. Self-efficacy for managing symptoms

    Time frame: 24 weeks

    PROMIS SF v1.0 Managing Symptoms 4a

  14. Self-efficacy for managing daily activities

    Time frame: 24 weeks

    PROMIS SF v1.0 Managing daily activities 4a

  15. Self-efficacy for managing sleep disturbance

    Time frame: 24 weeks

    PROMIS SF v1.0 Sleep Disturbance 4a

  16. Self-efficacy for managing sleep-related impairments

    Time frame: 24 weeks

    PROMIS SF v1.0 Sleep-related impairment

  17. Dietary Intake

    Time frame: 24 weeks

    Short Healthy Eating Index

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Registry information

Official study title

An Accessible and Inclusive Artificial Intelligence Assisted Chronic Disease Self-Management Telehealth Platform: A Pilot Study

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 1, 2022
Registry last updated
Dec 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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