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

Not Applicable

Recruiting

• Conditions: Chronic Conditions, Multiple; Disability Physical; Chronic Condition
• Interventions: Behavioral: No Scheduled Coaching Calls + Gamified Rewards; Behavioral: Scheduled Coaching + Gamified Rewards; Behavioral: Scheduled Coaching Calls + Independent Rewards; Behavioral: No Scheduled Coaching Calls + Independent rewards

• Registration Number: NCT05481593
• Lead Sponsor: University of Alabama at Birmingham

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 Timeline

• Study First Submitted: 2022-07-27
• Study First Submitted QC: 2022-07-28
• Study First Posted: 2022-08-01
• Study Start: 2024-02-01
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-16
• Last Update Posted: 2024-10-18
• Primary Completion: 2025-10-31
• Study Completion: 2025-10-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 212

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
No Scheduled Coaching Call & Gamified Rewards	No Scheduled Coaching Calls + Gamified Rewards	-
Scheduled Coaching Calls & Gamified Rewards	Scheduled Coaching + Gamified Rewards	-
Scheduled Coaching Calls & Independent rewards (No Gamification)	Scheduled Coaching Calls + Independent Rewards	-
No Scheduled Coaching Calls & Independent Rewards (No Gamification)	No Scheduled Coaching Calls + Independent rewards	-

Primary Outcome Measures

Name	Time	Method
Health-related quality-of-life	24 Weeks	Enabled version of Short-Form 36 (SF-36E)

Secondary Outcome Measures

Name	Time	Method
Physical activity	24 weeks	Godin leisure time exercise questionnaire
Medication adherence	24 weeks	Turnkey Adherence Strategy Medication Adherence
Self-efficacy for managing psychosocial illness	24 weeks	PROMIS SF v1.0 Psychosocial illness impact 8a
Self-efficacy for managing medications	24 weeks	PROMIS SF v1.0 Managing Emotions 4a
Self-efficacy for managing social interactions	24 weeks	PROMIS SF v1.0 Social Interactions 4a
Physical Activity	24 weeks	Measured via data from FitBit device (Steps)
Self-efficacy for managing emotions	24 weeks	PROMIS SF v1.0 Managing Emotions 4a
Self-efficacy for managing sleep disturbance	24 weeks	PROMIS SF v1.0 Sleep Disturbance 4a
Usability	24 weeks	Health Information Technology Usability Evaluation Scale
Self-efficacy for managing depression	24 weeks	PROMIS SF v1.0 Emotional Distress-Depression 4a
Dietary Intake	24 weeks	Short Healthy Eating Index
Self-efficacy for managing daily activities	24 weeks	PROMIS SF v1.0 Managing daily activities 4a
Self-efficacy for managing sleep-related impairments	24 weeks	PROMIS SF v1.0 Sleep-related impairment
Self-efficacy for managing symptoms	24 weeks	PROMIS SF v1.0 Managing Symptoms 4a

Trial Locations

Locations (1)

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States