MyStroke in Chronic Stroke

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: Stroke
• Intervention / Treatment: Behavioral: MyStroke

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Christopher G Favilla, MD; Phone Number: 2156153727; Email: christopher.favilla@pennmedicine.upenn.edu

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Recruiting
      • The Hospital of the University of Pennsylvania
      • Contact: Nichole Gallatti; Email: Nichole.Gallatti@pennmedicine.upenn.edu
      • Contact: Christopher Favilla; Email: christopher.favilla@penmmedicine.upenn.edu

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

2

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	Behavioral: MyStroke; 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)	The proportion of patients who correctly identify their stroke etiology	90 days
Stroke risk factor recognition (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)	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)	The proportion of patients who correctly identify their antithrombotic medications	7 days
Stroke prevention medication recognition (90 days)	The proportion of patients who correctly identify their antithrombotic medications	90 days
Stroke etiology recognition (7 days)	The proportion of patients who correctly identify their stroke etiology	7 days
Stroke risk factor recognition (7 days)	The proportion of patients who correctly identify at least one of their vascular risk factors	7 days
modified Rankin Scale	Ordinal functional disability scale (score 0 - 6)	90 days
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)	7 days
Stroke patient education retention (SPER) survey (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)	total score from the 5-question SPER (scale 0-10; higher score reflects better knowledge)	90 days
EuroQOL - visual analog scale (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)	patient-reported quality of life score (scale 0-100; higher score reflects better self-reported quality of life)	90 days
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)	7 days
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)	90 days

Collaborators and Investigators

• Sponsor: University of Pennsylvania

Study record dates

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

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: 854145

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No