Clinical trial NCT05481593: An Accessible and Inclusive Artificial Intelligence Assisted Chronic Disease Self-Management Telehealth Platform
Official title: An Accessible and Inclusive Artificial Intelligence Assisted Chronic Disease Self-Management Telehealth Platform: a Pilot Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Disability Physical
Chronic Condition
Chronic Conditions, Multiple
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2022-08-01
Enrollment: 212
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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)

Primary outcomes:
measure: Health-related quality-of-life
timeFrame: 24 Weeks
Secondary outcomes:
measure: Physical activity
timeFrame: 24 weeks
measure: Usability
timeFrame: 24 weeks
measure: Usability
timeFrame: 24 weeks
measure: Medication adherence
timeFrame: 24 weeks
measure: Medication adherence
timeFrame: 24 weeks
measure: Self-efficacy for managing depression
timeFrame: 24 weeks
measure: Self-efficacy for managing psychosocial illness
timeFrame: 24 weeks
measure: Self-efficacy for managing emotions
timeFrame: 24 weeks
measure: Self-efficacy for managing medications
timeFrame: 24 weeks
measure: Self-efficacy for managing social interactions
timeFrame: 24 weeks
measure: Physical Activity
timeFrame: 24 weeks
measure: Physical Activity
timeFrame: 24 weeks
measure: Self-efficacy for managing symptoms
timeFrame: 24 weeks
measure: Self-efficacy for managing daily activities
timeFrame: 24 weeks
measure: Self-efficacy for managing sleep disturbance
timeFrame: 24 weeks
measure: Self-efficacy for managing sleep-related impairments
timeFrame: 24 weeks
measure: Dietary Intake
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
References: