MyStroke in Chronic Stroke

• Sponsor: University of Pennsylvania (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT06057753
• Collaborator: (none)
• Enrollment: 100
• Arms: 2
• Anticipated Duration (Months): 8

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Stroke	Behavioral: MyStroke	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Personalized Video-based Education for Chronic Stroke Survivors: A Randomized Clinical Trial
• Anticipated Study Start Date: Oct 1, 2023
• Anticipated Primary Completion Date: Jun 1, 2024
• Anticipated Study Completion Date: Jun 1, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Patient satisfaction with stroke education (90 days) [90 days]

   5-point Likert-scale

2. Stroke etiology recognition (90 days) [90 days]

   The proportion of patients who correctly identify their stroke etiology

3. Stroke risk factor recognition (90 days) [90 days]

   The proportion of patients who correctly identify at least one of their vascular risk factors

Secondary Outcome Measures

1. Stroke prevention medication recognition (7 days) [7 days]

   The proportion of patients who correctly identify their antithrombotic medications

2. Stroke prevention medication recognition (90 days) [90 days]

   The proportion of patients who correctly identify their antithrombotic medications

3. Patient satisfaction with stroke education (7 days) [7 days]

   5-point Likert-scale

4. Stroke etiology recognition (7 days) [7 days]

   The proportion of patients who correctly identify their stroke etiology

5. Stroke risk factor recognition (7 days) [7 days]

   The proportion of patients who correctly identify at least one of their vascular risk factors

6. Stroke patient education retention (SPER) survey (7 days) [7 days]

   total score from the 5-question SPER

7. Stroke patient education retention (SPER) survey (90 days) [90 days]

   total score from the 5-question SPER

8. EuroQOL - visual analog score (7 days) [7 days]

   patient-reported quality of life score

9. EuroQOL - visual analog score (90 days) [90 days]

   patient-reported quality of life score

10. modified Rankin Scale [90 days]

    Ordinal functional disability scale (score 0 - 6)

11. Medication adherence (7 days) [7 days]

    total score of the Adherence Estimator (3 question survey)

12. Medication adherence (90 days) [90 days]

    total score of the Adherence Estimator (3 question survey)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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 ADLs

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 NIHSS item 9)

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• University of Pennsylvania

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Christopher Favilla, Assistant Professor of Neurology, University of Pennsylvania
• ClinicalTrials.gov Identifier: NCT06057753
• Other Study ID Numbers: 854145
• First Posted: Sep 28, 2023
• Last Update Posted: Sep 28, 2023
• Last Verified: Sep 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Stroke

Study Results

No Results Posted as of Sep 28, 2023