Personalized Patient and Caregiver Education After Stroke (MyStroke)

This is a randomized pilot trial to evaluate the impact of a customizable stroke education app (vs standard of care discharge education) on patient satisfaction and education retention. The impact of the intervention will be assessed 7, 30, and 90 days post-discharge.

Study Overview

• Status: Completed
• Conditions: Stroke; Stroke, Ischemic; Stroke, Acute
• Intervention / Treatment: Behavioral: Customized education; Behavioral: Standard of care discharge education

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Hospital of the University of Pennsylvania

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Admitted for ischemic stroke
• At least 18 years old
• Patient or caregiver has access to a smart phone, tablet or computer
• Being discharged to either home or acute rehab

Exclusion Criteria:

• Patient or caregivers unable or unwilling to access the customized app with a smartphone, tablet, or computer
• Being discharged to a skilled nursing facility
• moderate-to-severe aphasia at the time of enrollment (as per NIHSS scoring) if patient is being enrolled without a caregiver

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Customized education app; A customized URL-based platform will present brief education videos addressing a patients stroke etiology, risk factors, stroke prevention medications, and post-stroke lifestyle issues. This URL will be made available to the patient and caregiver.	Behavioral: Customized education; Half of subjects will receive access to a customized app that will include brief educational videos that have been selected for each patient based on their medical history. These videos will address stroke etiology, underlying risk factors, and stroke prevention medications.
Placebo Comparator: Standard of care discharge education; Standard discharge education is performed by the bedside nurse at the time of hospital discharge.	Behavioral: Standard of care discharge education; Half of subjects will be randomized to receive typical discharge education, per the institutional guidelines for standard of care education for stroke patients.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient satisfaction survey	Likert-style survey assessing patient satisfaction and perception of the stroke education they received.	Day 90
Stroke Patient Education Retention (SPER) survey	Validated measure of stroke patient education as it pertains to their stroke etiology and risk factors with scores of 0-10	Day 90
Stroke etiology awareness	accurate knowledge of stroke etiology (0=incorrect; 1=correct)	Day 90
EuroQOL-VAS	validated quality of life metric, with scores of 0-100	Day 90

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stroke risk factor awareness, 90 days	accurate knowledge of stroke risk factors (0=incorrect; 1=correct)	Day 90
Stroke risk factor awareness, 30 days	accurate knowledge of stroke risk factors (0=incorrect; 1=correct)	Day 30
Stroke risk factor awareness. 7 days	accurate knowledge of stroke risk factors (0=incorrect; 1=correct)	Day 7
Stroke prevention med awareness, 90 days	accurate knowledge of stroke prevention medications (0=incorrect; 1=correct)	Day 90
Stroke prevention med awareness, 30 days	accurate knowledge of stroke prevention medications (0=incorrect; 1=correct)	Day 30
Stroke prevention med awareness, 7 days	accurate knowledge of stroke prevention medications (0=incorrect; 1=correct)	Day 7
Patient satisfaction, 30 days	Likert-style survey assessing patient satisfaction and perception of the stroke education	Day 30
Patient satisfaction, 7 days	Likert-style survey assessing patient satisfaction and perception of the stroke education	Day 7
SPER, 7 days	Stroke Patient Education Retention (SPER) survey	Day 7
SPER, 30 days	Stroke Patient Education Retention (SPER) survey	Day 30
Stroke etiology awareness	accurate knowledge of stroke etiology (0=incorrect; 1=correct)	Day 7
Stroke etiology awareness	accurate knowledge of stroke etiology (0=incorrect; 1=correct)	Day 30

Collaborators and Investigators

• Sponsor: University of Pennsylvania
• Investigators: Principal Investigator: Christopher Favilla, M.D., University of Pennsylvania

Study record dates

Study Major Dates

• Study Start (Actual): October 20, 2021
• Primary Completion (Actual): April 2, 2023
• Study Completion (Actual): April 2, 2023

Study Registration Dates

• First Submitted: October 12, 2021
• First Submitted That Met QC Criteria: November 1, 2021
• First Posted (Actual): November 12, 2021

Study Record Updates

• Last Update Posted (Actual): October 26, 2023
• Last Update Submitted That Met QC Criteria: October 25, 2023
• Last Verified: October 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; Ischemic Stroke
• Other Study ID Numbers: 833723

Drug and device information, study documents

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