MyStroke in Chronic Stroke

November 7, 2023 updated by: Christopher Favilla, University of Pennsylvania

Personalized Video-based Education for Chronic Stroke Survivors: A Randomized Clinical Trial

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. History of ischemic stroke between 1 and 10 years prior to enrollment
  2. Receiving outpatient stroke care at the Hospital of the University of Pennsylvania
  3. At least 18 years old
  4. Access to a smart phone, tablet, or computer
  5. Willingness to complete 2 follow-up surveys (7 days and 90 day post-enrollment)

Exclusion Criteria:

  1. Unwilling or unable to access the customized app with a smartphone, tablet, or computer
  2. Complete dependence on caregiver for all activities of daily living
  3. Stroke occurred less than 1 year or greater than 10 years prior to screening/enrollment
  4. Patient has severe aphasia (score of greater than or equal to 2 on National Institutes of Health Stroke Scale item 9)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Standard Education
Standard stroke patient education as per the medical providers
Experimental: MyStroke
Access to a personalized video-based stroke educational platform
Personalized video-based stroke education platform

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stroke etiology recognition (90 days)
Time Frame: 90 days
The proportion of patients who correctly identify their stroke etiology
90 days
Stroke risk factor recognition (90 days)
Time Frame: 90 days
The proportion of patients who correctly identify at least one of their vascular risk factors
90 days
Patient satisfaction with stroke education (90 days)
Time Frame: 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)
90 days

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 17, 2023

Primary Completion (Estimated)

June 1, 2024

Study Completion (Estimated)

June 1, 2024

Study Registration Dates

First Submitted

August 22, 2023

First Submitted That Met QC Criteria

September 26, 2023

First Posted (Actual)

September 28, 2023

Study Record Updates

Last Update Posted (Estimated)

November 9, 2023

Last Update Submitted That Met QC Criteria

November 7, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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