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MyStroke in Chronic Stroke

Primary Purpose

Stroke

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
MyStroke
Sponsored by
University of Pennsylvania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke

Eligibility Criteria

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

Inclusion Criteria: History of ischemic stroke between 1 and 10 years prior to enrollment Receiving outpatient stroke care at the Hospital of the University of Pennsylvania At least 18 years old Access to a smart phone, tablet, or computer Willingness to complete 2 follow-up surveys (7 days and 90 day post-enrollment) Exclusion Criteria: Unwilling or unable to access the customized app with a smartphone, tablet, or computer Complete dependence on caregiver for all activities of daily living Stroke occurred less than 1 year or greater than 10 years prior to screening/enrollment Patient has severe aphasia (score of greater than or equal to 2 on National Institutes of Health Stroke Scale item 9)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    No Intervention

    Experimental

    Arm Label

    Standard Education

    MyStroke

    Arm Description

    Standard stroke patient education as per the medical providers

    Access to a personalized video-based stroke educational platform

    Outcomes

    Primary Outcome Measures

    Patient satisfaction with stroke education (90 days)
    5-point Likert-scale (Q: I am satisfied with the quality of my stroke education; Answers range from strongly disagree to strongly agree)
    Stroke etiology recognition (90 days)
    The proportion of patients who correctly identify their stroke etiology
    Stroke risk factor recognition (90 days)
    The proportion of patients who correctly identify at least one of their vascular risk factors

    Secondary Outcome Measures

    Stroke prevention medication recognition (7 days)
    The proportion of patients who correctly identify their antithrombotic medications
    Stroke prevention medication recognition (90 days)
    The proportion of patients who correctly identify their antithrombotic medications
    Patient satisfaction with stroke education (7 days)
    5-point Likert-scale (Q: I am satisfied with the quality of my stroke education; Answers range from strongly disagree to strongly agree)
    Stroke etiology recognition (7 days)
    The proportion of patients who correctly identify their stroke etiology
    Stroke risk factor recognition (7 days)
    The proportion of patients who correctly identify at least one of their vascular risk factors
    Stroke patient education retention (SPER) survey (7 days)
    total score from the 5-question SPER (scale 0-10; higher score reflects better knowledge)
    Stroke patient education retention (SPER) survey (90 days)
    total score from the 5-question SPER (scale 0-10; higher score reflects better knowledge)
    EuroQOL - visual analog scale (7 days)
    patient-reported quality of life score (scale 0-100; higher score reflects better self-reported quality of life)
    EuroQOL - visual analog scale (90 days)
    patient-reported quality of life score (scale 0-100; higher score reflects better self-reported quality of life)
    modified Rankin Scale
    Ordinal functional disability scale (score 0 - 6)
    Medication adherence (7 days)
    total score of the Adherence Estimator (3 question survey; total score 0-36; higher score reflects higher risk of non-adherence)
    Medication adherence (90 days)
    total score of the Adherence Estimator (3 question survey; total score 0-36; higher score reflects higher risk of non-adherence)

    Full Information

    First Posted
    August 22, 2023
    Last Updated
    October 10, 2023
    Sponsor
    University of Pennsylvania
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06057753
    Brief Title
    MyStroke in Chronic Stroke
    Official Title
    Personalized Video-based Education for Chronic Stroke Survivors: A Randomized Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 2023 (Anticipated)
    Primary Completion Date
    June 2024 (Anticipated)
    Study Completion Date
    June 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Pennsylvania

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    This is a single-center randomized control trial assessing the impact of a personalized video-based educational platform on patients satisfaction and stroke knowledge in the context of chronic stroke.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Stroke

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    100 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Standard Education
    Arm Type
    No Intervention
    Arm Description
    Standard stroke patient education as per the medical providers
    Arm Title
    MyStroke
    Arm Type
    Experimental
    Arm Description
    Access to a personalized video-based stroke educational platform
    Intervention Type
    Behavioral
    Intervention Name(s)
    MyStroke
    Intervention Description
    Personalized video-based stroke education platform
    Primary Outcome Measure Information:
    Title
    Patient satisfaction with stroke education (90 days)
    Description
    5-point Likert-scale (Q: I am satisfied with the quality of my stroke education; Answers range from strongly disagree to strongly agree)
    Time Frame
    90 days
    Title
    Stroke etiology recognition (90 days)
    Description
    The proportion of patients who correctly identify their stroke etiology
    Time Frame
    90 days
    Title
    Stroke risk factor recognition (90 days)
    Description
    The proportion of patients who correctly identify at least one of their vascular risk factors
    Time Frame
    90 days
    Secondary Outcome Measure Information:
    Title
    Stroke prevention medication recognition (7 days)
    Description
    The proportion of patients who correctly identify their antithrombotic medications
    Time Frame
    7 days
    Title
    Stroke prevention medication recognition (90 days)
    Description
    The proportion of patients who correctly identify their antithrombotic medications
    Time Frame
    90 days
    Title
    Patient satisfaction with stroke education (7 days)
    Description
    5-point Likert-scale (Q: I am satisfied with the quality of my stroke education; Answers range from strongly disagree to strongly agree)
    Time Frame
    7 days
    Title
    Stroke etiology recognition (7 days)
    Description
    The proportion of patients who correctly identify their stroke etiology
    Time Frame
    7 days
    Title
    Stroke risk factor recognition (7 days)
    Description
    The proportion of patients who correctly identify at least one of their vascular risk factors
    Time Frame
    7 days
    Title
    Stroke patient education retention (SPER) survey (7 days)
    Description
    total score from the 5-question SPER (scale 0-10; higher score reflects better knowledge)
    Time Frame
    7 days
    Title
    Stroke patient education retention (SPER) survey (90 days)
    Description
    total score from the 5-question SPER (scale 0-10; higher score reflects better knowledge)
    Time Frame
    90 days
    Title
    EuroQOL - visual analog scale (7 days)
    Description
    patient-reported quality of life score (scale 0-100; higher score reflects better self-reported quality of life)
    Time Frame
    7 days
    Title
    EuroQOL - visual analog scale (90 days)
    Description
    patient-reported quality of life score (scale 0-100; higher score reflects better self-reported quality of life)
    Time Frame
    90 days
    Title
    modified Rankin Scale
    Description
    Ordinal functional disability scale (score 0 - 6)
    Time Frame
    90 days
    Title
    Medication adherence (7 days)
    Description
    total score of the Adherence Estimator (3 question survey; total score 0-36; higher score reflects higher risk of non-adherence)
    Time Frame
    7 days
    Title
    Medication adherence (90 days)
    Description
    total score of the Adherence Estimator (3 question survey; total score 0-36; higher score reflects higher risk of non-adherence)
    Time Frame
    90 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: History of ischemic stroke between 1 and 10 years prior to enrollment Receiving outpatient stroke care at the Hospital of the University of Pennsylvania At least 18 years old Access to a smart phone, tablet, or computer Willingness to complete 2 follow-up surveys (7 days and 90 day post-enrollment) Exclusion Criteria: Unwilling or unable to access the customized app with a smartphone, tablet, or computer Complete dependence on caregiver for all activities of daily living Stroke occurred less than 1 year or greater than 10 years prior to screening/enrollment Patient has severe aphasia (score of greater than or equal to 2 on National Institutes of Health Stroke Scale item 9)
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Christopher G Favilla, MD
    Phone
    2156153727
    Email
    christopher.favilla@pennmedicine.upenn.edu

    12. IPD Sharing Statement

    Learn more about this trial

    MyStroke in Chronic Stroke

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