MyStroke: Personalized Patient and Caregiver Education After Stroke

Sponsor

University of Pennsylvania (Other)

Overall Status

Recruiting

CT.gov ID

NCT05118503

Collaborator

(none)

120

Enrollment

Location

Arms

18.1

Anticipated Duration (Months)

6.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Stroke, Acute Stroke, Ischemic Stroke	Behavioral: Customized education Behavioral: Standard of care discharge education	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

Personalized Patient and Caregiver Education After Stroke

Actual Study Start Date :

Sep 24, 2021

Anticipated Primary Completion Date :

Oct 31, 2022

Anticipated Study Completion Date :

Mar 30, 2023

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Patient satisfaction survey [Day 90]
Likert-style survey assessing patient satisfaction and perception of the stroke education they received.
Stroke Patient Education Retention (SPER) survey [Day 90]
Validated measure of stroke patient education as it pertains to their stroke etiology and risk factors with scores of 0-10
Euro Quality of Life (EuroQOL) survey [Day 90]
validated quality of life metric, with scores of 0-100

Secondary Outcome Measures

Stroke Impact Scale [Day 90]
Standardized quality of life metric post stroke

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania	United States	19104

Sponsors and Collaborators

University of Pennsylvania

Investigators

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

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:

NCT05118503

Other Study ID Numbers:

833723

First Posted:

Nov 12, 2021

Last Update Posted:

Nov 12, 2021

Last Verified:

Nov 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Stroke

Ischemic Stroke

Study Results

No Results Posted as of Nov 12, 2021