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

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

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: Interventional
• Enrollment (Estimated): 212
• Phase: Not Applicable

Contacts and Locations

• Study Contact: 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
      • Recruiting
      • University of Alabama at Birmingham
      • Contact: Eric Evans, PhD

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Health-related quality-of-life	Enabled version of Short-Form 36 (SF-36E)	24 Weeks

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2024
• Primary Completion (Estimated): October 1, 2024
• Study Completion (Estimated): October 1, 2024

Study Registration Dates

• First Submitted: July 27, 2022
• First Submitted That Met QC Criteria: July 28, 2022
• First Posted (Actual): August 1, 2022

Study Record Updates

• Last Update Posted (Estimated): February 5, 2024
• Last Update Submitted That Met QC Criteria: February 1, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Disease; Chronic Disease; Multiple Chronic Conditions
• Other Study ID 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