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

Disability Physical Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05481593
• Other study ID #: IRB-300009485
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2024
• Est. completion date: October 2024

Study information

• Verified date: February 2024
• Source: University of Alabama at Birmingham
• Contact: Eric J Evans, PhD
• Phone: 205-934-7189
• Email: evansej[@]uab.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 212
• Est. completion date: October 2024
• Est. primary completion date: October 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Chronic Conditions, Multiple
• Chronic Disease
• Disability Physical
• Disease
• Multiple Chronic Conditions

Intervention

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)
• Scheduled Coaching Calls + Independent Rewards
Participants will receive scheduled coaching calls and receive fixed rewards (i.e., non-increasing)
• 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)
• No Scheduled Coaching Calls + Independent rewards
Participants will not have scheduled coaching calls and receive fixed rewards (i.e., non-increasing)

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Health-related quality-of-life	Enabled version of Short-Form 36 (SF-36E)	24 Weeks
Secondary	Physical activity	Godin leisure time exercise questionnaire	24 weeks
Secondary	Usability	System Usability Scale	24 weeks
Secondary	Usability	Health Information Technology Usability Evaluation Scale	24 weeks
Secondary	Medication adherence	Medication adherence rating scale	24 weeks
Secondary	Medication adherence	Turnkey Adherence Strategy Medication Adherence	24 weeks
Secondary	Self-efficacy for managing depression	PROMIS SF v1.0 Emotional Distress-Depression 4a	24 weeks
Secondary	Self-efficacy for managing psychosocial illness	PROMIS SF v1.0 Psychosocial illness impact 8a	24 weeks
Secondary	Self-efficacy for managing emotions	PROMIS SF v1.0 Managing Emotions 4a	24 weeks
Secondary	Self-efficacy for managing medications	PROMIS SF v1.0 Managing Emotions 4a	24 weeks
Secondary	Self-efficacy for managing social interactions	PROMIS SF v1.0 Social Interactions 4a	24 weeks
Secondary	Physical Activity	Measured via data from FitBit device (Minutes)	24 weeks
Secondary	Physical Activity	Measured via data from FitBit device (Steps)	24 weeks
Secondary	Self-efficacy for managing symptoms	PROMIS SF v1.0 Managing Symptoms 4a	24 weeks
Secondary	Self-efficacy for managing daily activities	PROMIS SF v1.0 Managing daily activities 4a	24 weeks
Secondary	Self-efficacy for managing sleep disturbance	PROMIS SF v1.0 Sleep Disturbance 4a	24 weeks
Secondary	Self-efficacy for managing sleep-related impairments	PROMIS SF v1.0 Sleep-related impairment	24 weeks
Secondary	Dietary Intake	Short Healthy Eating Index	24 weeks