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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05481593
Enrollment
212
Registered
2022-08-01
Start date
2024-02-01
Completion date
2025-10-31
Last updated
2025-12-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Condition, Chronic Conditions, Multiple, Disability Physical

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.

Interventions

BEHAVIORALScheduled Coaching + Gamified Rewards

Participants will receive scheduled coaching calls and receive gamified rewards (i.e., earning points over time and converted to monetary gifts)

BEHAVIORALScheduled Coaching Calls + Independent Rewards

Participants will receive scheduled coaching calls and receive fixed rewards (i.e., non-increasing)

BEHAVIORALNo 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)

BEHAVIORALNo Scheduled Coaching Calls + Independent rewards

Participants will not have scheduled coaching calls and receive fixed rewards (i.e., non-increasing)

Sponsors

University of Alabama at Birmingham
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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)

Design outcomes

Primary

MeasureTime frameDescription
Health-related quality-of-life24 WeeksEnabled version of Short-Form 36 (SF-36E)

Secondary

MeasureTime frameDescription
Usability24 weeksSystem Usability Scale
Medication adherence24 weeksMedication adherence rating scale
Self-efficacy for managing depression24 weeksPROMIS SF v1.0 Emotional Distress-Depression 4a
Self-efficacy for managing psychosocial illness24 weeksPROMIS SF v1.0 Psychosocial illness impact 8a
Self-efficacy for managing emotions24 weeksPROMIS SF v1.0 Managing Emotions 4a
Self-efficacy for managing medications24 weeksPROMIS SF v1.0 Managing Emotions 4a
Physical activity24 weeksGodin leisure time exercise questionnaire
Physical Activity24 weeksMeasured via data from FitBit device (Minutes)
Self-efficacy for managing symptoms24 weeksPROMIS SF v1.0 Managing Symptoms 4a
Self-efficacy for managing daily activities24 weeksPROMIS SF v1.0 Managing daily activities 4a
Self-efficacy for managing sleep disturbance24 weeksPROMIS SF v1.0 Sleep Disturbance 4a
Self-efficacy for managing sleep-related impairments24 weeksPROMIS SF v1.0 Sleep-related impairment
Dietary Intake24 weeksShort Healthy Eating Index
Self-efficacy for managing social interactions24 weeksPROMIS SF v1.0 Social Interactions 4a

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 9, 2026