MyStroke in Chronic Stroke

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06057753
• Other study ID #: 854145
• Status: Recruiting
• Phase: N/A
• Start date: October 17, 2023
• Est. completion date: June 2024

Study information

• Verified date: November 2023
• Source: University of Pennsylvania
• Contact: Christopher G Favilla, MD
• Phone: 2156153727
• Email: christopher.favilla[@]pennmedicine.upenn.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: June 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Stroke

Intervention

Behavioral:
• MyStroke
Personalized video-based stroke education platform

Locations

Country	Name	City	State
United States	The Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Stroke etiology recognition (90 days)	The proportion of patients who correctly identify their stroke etiology	90 days
Primary	Stroke risk factor recognition (90 days)	The proportion of patients who correctly identify at least one of their vascular risk factors	90 days
Secondary	Stroke prevention medication recognition (7 days)	The proportion of patients who correctly identify their antithrombotic medications	7 days
Secondary	Stroke prevention medication recognition (90 days)	The proportion of patients who correctly identify their antithrombotic medications	90 days
Secondary	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
Secondary	Stroke etiology recognition (7 days)	The proportion of patients who correctly identify their stroke etiology	7 days
Secondary	Stroke risk factor recognition (7 days)	The proportion of patients who correctly identify at least one of their vascular risk factors	7 days
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	modified Rankin Scale	Ordinal functional disability scale (score 0 - 6)	90 days
Secondary	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
Secondary	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