An Accessible and Inclusive Artificial Intelligence Assisted Chronic Disease Self-Management Telehealth Platform
Primary Purpose
Disability Physical, Chronic Condition, Chronic Conditions, Multiple
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Scheduled Coaching + Gamified Rewards
Scheduled Coaching Calls + Independent Rewards
No Scheduled Coaching Calls + Gamified Rewards
No Scheduled Coaching Calls + Independent rewards
Sponsored by
About this trial
This is an interventional other trial for Disability Physical
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)
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
Scheduled Coaching Calls & Gamified Rewards
No Scheduled Coaching Call & Gamified Rewards
Scheduled Coaching Calls & Independent rewards (No Gamification)
No Scheduled Coaching Calls & Independent Rewards (No Gamification)
Arm Description
Outcomes
Primary Outcome Measures
Health-related quality-of-life
Enabled version of Short-Form 36 (SF-36E)
Secondary Outcome Measures
Physical activity
Godin leisure time exercise questionnaire
Usability
System Usability Scale
Usability
Health Information Technology Usability Evaluation Scale
Medication adherence
Medication adherence rating scale
Medication adherence
Turnkey Adherence Strategy Medication Adherence
Self-efficacy for managing depression
PROMIS SF v1.0 Emotional Distress-Depression 4a
Self-efficacy for managing psychosocial illness
PROMIS SF v1.0 Psychosocial illness impact 8a
Self-efficacy for managing emotions
PROMIS SF v1.0 Managing Emotions 4a
Self-efficacy for managing medications
PROMIS SF v1.0 Managing Emotions 4a
Self-efficacy for managing social interactions
PROMIS SF v1.0 Social Interactions 4a
Physical Activity
Measured via data from FitBit device (Minutes)
Physical Activity
Measured via data from FitBit device (Steps)
Self-efficacy for managing symptoms
PROMIS SF v1.0 Managing Symptoms 4a
Self-efficacy for managing daily activities
PROMIS SF v1.0 Managing daily activities 4a
Self-efficacy for managing sleep disturbance
PROMIS SF v1.0 Sleep Disturbance 4a
Self-efficacy for managing sleep-related impairments
PROMIS SF v1.0 Sleep-related impairment
Dietary Intake
Short Healthy Eating Index
Full Information
NCT ID
NCT05481593
First Posted
July 27, 2022
Last Updated
September 29, 2023
Sponsor
University of Alabama at Birmingham
1. Study Identification
Unique Protocol Identification Number
NCT05481593
Brief Title
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
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 2023 (Anticipated)
Primary Completion Date
September 2024 (Anticipated)
Study Completion Date
September 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Disability Physical, Chronic Condition, Chronic Conditions, Multiple
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
212 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Scheduled Coaching Calls & Gamified Rewards
Arm Type
Experimental
Arm Title
No Scheduled Coaching Call & Gamified Rewards
Arm Type
Experimental
Arm Title
Scheduled Coaching Calls & Independent rewards (No Gamification)
Arm Type
Experimental
Arm Title
No Scheduled Coaching Calls & Independent Rewards (No Gamification)
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Scheduled Coaching + Gamified Rewards
Intervention Description
Participants will receive scheduled coaching calls and receive gamified rewards (i.e., earning points over time and converted to monetary gifts)
Intervention Type
Behavioral
Intervention Name(s)
Scheduled Coaching Calls + Independent Rewards
Intervention Description
Participants will receive scheduled coaching calls and receive fixed rewards (i.e., non-increasing)
Intervention Type
Behavioral
Intervention Name(s)
No Scheduled Coaching Calls + Gamified Rewards
Intervention Description
Participants will not have scheduled coaching calls and receive gamified rewards (i.e., earning points over time and converted to monetary gifts)
Intervention Type
Behavioral
Intervention Name(s)
No Scheduled Coaching Calls + Independent rewards
Intervention Description
Participants will not have scheduled coaching calls and receive fixed rewards (i.e., non-increasing)
Primary Outcome Measure Information:
Title
Health-related quality-of-life
Description
Enabled version of Short-Form 36 (SF-36E)
Time Frame
24 Weeks
Secondary Outcome Measure Information:
Title
Physical activity
Description
Godin leisure time exercise questionnaire
Time Frame
24 weeks
Title
Usability
Description
System Usability Scale
Time Frame
24 weeks
Title
Usability
Description
Health Information Technology Usability Evaluation Scale
Time Frame
24 weeks
Title
Medication adherence
Description
Medication adherence rating scale
Time Frame
24 weeks
Title
Medication adherence
Description
Turnkey Adherence Strategy Medication Adherence
Time Frame
24 weeks
Title
Self-efficacy for managing depression
Description
PROMIS SF v1.0 Emotional Distress-Depression 4a
Time Frame
24 weeks
Title
Self-efficacy for managing psychosocial illness
Description
PROMIS SF v1.0 Psychosocial illness impact 8a
Time Frame
24 weeks
Title
Self-efficacy for managing emotions
Description
PROMIS SF v1.0 Managing Emotions 4a
Time Frame
24 weeks
Title
Self-efficacy for managing medications
Description
PROMIS SF v1.0 Managing Emotions 4a
Time Frame
24 weeks
Title
Self-efficacy for managing social interactions
Description
PROMIS SF v1.0 Social Interactions 4a
Time Frame
24 weeks
Title
Physical Activity
Description
Measured via data from FitBit device (Minutes)
Time Frame
24 weeks
Title
Physical Activity
Description
Measured via data from FitBit device (Steps)
Time Frame
24 weeks
Title
Self-efficacy for managing symptoms
Description
PROMIS SF v1.0 Managing Symptoms 4a
Time Frame
24 weeks
Title
Self-efficacy for managing daily activities
Description
PROMIS SF v1.0 Managing daily activities 4a
Time Frame
24 weeks
Title
Self-efficacy for managing sleep disturbance
Description
PROMIS SF v1.0 Sleep Disturbance 4a
Time Frame
24 weeks
Title
Self-efficacy for managing sleep-related impairments
Description
PROMIS SF v1.0 Sleep-related impairment
Time Frame
24 weeks
Title
Dietary Intake
Description
Short Healthy Eating Index
Time Frame
24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eric J Evans, PhD
Phone
205-934-7189
Email
evansej@uab.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Mohanraj Thirumalai, PhD
Phone
205-934-7189
Email
mohanraj@uab.edu
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
An Accessible and Inclusive Artificial Intelligence Assisted Chronic Disease Self-Management Telehealth Platform
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