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Clinical Trials/NCT05481593
NCT05481593CompletedNot 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 enrollmentStarted: February 1, 2024Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
212
Locations
1
Primary Endpoint
Health-related quality-of-life

Study 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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Other
Masking
Double (Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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)

Arms & Interventions

Scheduled Coaching Calls & Gamified Rewards

Experimental

Intervention: Scheduled Coaching + Gamified Rewards (Behavioral)

No Scheduled Coaching Call & Gamified Rewards

Experimental

Intervention: No Scheduled Coaching Calls + Gamified Rewards (Behavioral)

Scheduled Coaching Calls & Independent rewards (No Gamification)

Experimental

Intervention: Scheduled Coaching Calls + Independent Rewards (Behavioral)

No Scheduled Coaching Calls & Independent Rewards (No Gamification)

Experimental

Intervention: No Scheduled Coaching Calls + Independent rewards (Behavioral)

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)
  • Usability(24 weeks)
  • Medication adherence(24 weeks)
  • Physical activity(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)
  • Self-efficacy for managing emotions(24 weeks)
  • Self-efficacy for managing sleep disturbance(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)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Mohanraj Thirumalai

Assistant Professor

University of Alabama at Birmingham

Study Sites (1)

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