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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Disability Physical, Chronic Condition, Chronic Conditions, Multiple

Intervention / Treatment
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* Behavioral: Scheduled Coaching + Gamified Rewards
* Behavioral: Scheduled Coaching Calls + Independent Rewards
* Behavioral: No Scheduled Coaching Calls + Gamified Rewards
* Behavioral: No Scheduled Coaching Calls + Independent rewards


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Scheduled Coaching Calls & Gamified Rewards<br> | Behavioral: Scheduled Coaching + Gamified Rewards<br>* Participants will receive scheduled coaching calls and receive gamified rewards (i.e., earning points over time and converted to monetary gifts)<br>|
| Experimental: No Scheduled Coaching Call & Gamified Rewards<br> | Behavioral: No Scheduled Coaching Calls + Gamified Rewards<br>* Participants will not have scheduled coaching calls and receive gamified rewards (i.e., earning points over time and converted to monetary gifts)<br>|
| Experimental: Scheduled Coaching Calls & Independent rewards (No Gamification)<br> | Behavioral: Scheduled Coaching Calls + Independent Rewards<br>* Participants will receive scheduled coaching calls and receive fixed rewards (i.e., non-increasing)<br>|
| Experimental: No Scheduled Coaching Calls & Independent Rewards (No Gamification)<br> | Behavioral: No Scheduled Coaching Calls + Independent rewards<br>* Participants will not have scheduled coaching calls and receive fixed rewards (i.e., non-increasing)<br>|

What is the study measuring?
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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 |