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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
University of Alabama at Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Disability Physical

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    July 27, 2022
    Last Updated
    September 29, 2023
    Sponsor
    University of Alabama at Birmingham
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    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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