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Clinical Trials/NCT05481593
NCT05481593
Completed
Not Applicable

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

University of Alabama at Birmingham1 site in 1 country212 target enrollmentFebruary 1, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Disability Physical
Sponsor
University of Alabama at Birmingham
Enrollment
212
Locations
1
Primary Endpoint
Health-related quality-of-life
Status
Completed
Last Updated
4 months ago

Overview

Brief 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.

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.

Registry
clinicaltrials.gov
Start Date
February 1, 2024
End Date
October 31, 2025
Last Updated
4 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Mohanraj Thirumalai

Assistant Professor

University of Alabama at Birmingham

Eligibility Criteria

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)

Outcomes

Primary Outcomes

Health-related quality-of-life

Time Frame: 24 Weeks

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

Secondary Outcomes

  • Physical activity(24 weeks)
  • Medication adherence(24 weeks)
  • Self-efficacy for managing psychosocial illness(24 weeks)
  • Self-efficacy for managing medications(24 weeks)
  • Self-efficacy for managing social interactions(24 weeks)
  • Physical Activity(24 weeks)
  • Self-efficacy for managing sleep disturbance(24 weeks)
  • Self-efficacy for managing emotions(24 weeks)
  • Usability(24 weeks)
  • Self-efficacy for managing depression(24 weeks)
  • Dietary Intake(24 weeks)
  • Self-efficacy for managing daily activities(24 weeks)
  • Self-efficacy for managing sleep-related impairments(24 weeks)
  • Self-efficacy for managing symptoms(24 weeks)

Study Sites (1)

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