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Personalized Patient and Caregiver Education After Stroke (MyStroke)

Primary Purpose

Stroke, Acute, Stroke, Ischemic, Stroke

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Customized education
Standard of care discharge education
Sponsored by
University of Pennsylvania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Stroke, Acute

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Hospital of the University of Pennsylvania

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Customized education app

Standard of care discharge education

Arm Description

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.

Standard discharge education is performed by the bedside nurse at the time of hospital discharge.

Outcomes

Primary Outcome Measures

Patient satisfaction survey
Likert-style survey assessing patient satisfaction and perception of the stroke education they received.
Stroke etiology awareness
accurate knowledge of stroke etiology (0=incorrect; 1=correct)
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
EuroQOL-VAS
validated quality of life metric, with scores of 0-100

Secondary Outcome Measures

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

Full Information

First Posted
October 12, 2021
Last Updated
October 16, 2023
Sponsor
University of Pennsylvania
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1. Study Identification

Unique Protocol Identification Number
NCT05118503
Brief Title
Personalized Patient and Caregiver Education After Stroke
Acronym
MyStroke
Official Title
Personalized Patient and Caregiver Education After Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
September 24, 2021 (Actual)
Primary Completion Date
April 2, 2023 (Actual)
Study Completion Date
April 2, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pennsylvania

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Acute, Stroke, Ischemic, Stroke

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Customized education app
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Standard of care discharge education
Arm Type
Placebo Comparator
Arm Description
Standard discharge education is performed by the bedside nurse at the time of hospital discharge.
Intervention Type
Behavioral
Intervention Name(s)
Customized education
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Standard of care discharge education
Intervention Description
Half of subjects will be randomized to receive typical discharge education, per the institutional guidelines for standard of care education for stroke patients.
Primary Outcome Measure Information:
Title
Patient satisfaction survey
Description
Likert-style survey assessing patient satisfaction and perception of the stroke education they received.
Time Frame
Day 90
Title
Stroke etiology awareness
Description
accurate knowledge of stroke etiology (0=incorrect; 1=correct)
Time Frame
Day 90
Title
Stroke Patient Education Retention (SPER) survey
Description
Validated measure of stroke patient education as it pertains to their stroke etiology and risk factors with scores of 0-10
Time Frame
Day 90
Title
EuroQOL-VAS
Description
validated quality of life metric, with scores of 0-100
Time Frame
Day 90
Secondary Outcome Measure Information:
Title
Stroke etiology awareness
Description
accurate knowledge of stroke etiology (0=incorrect; 1=correct)
Time Frame
Day 7
Title
Stroke etiology awareness
Description
accurate knowledge of stroke etiology (0=incorrect; 1=correct)
Time Frame
Day 30
Title
Stroke risk factor awareness. 7 days
Description
accurate knowledge of stroke risk factors (0=incorrect; 1=correct)
Time Frame
Day 7
Title
Stroke risk factor awareness, 30 days
Description
accurate knowledge of stroke risk factors (0=incorrect; 1=correct)
Time Frame
Day 30
Title
Stroke risk factor awareness, 90 days
Description
accurate knowledge of stroke risk factors (0=incorrect; 1=correct)
Time Frame
Day 90
Title
Stroke prevention med awareness, 7 days
Description
accurate knowledge of stroke prevention medications (0=incorrect; 1=correct)
Time Frame
Day 7
Title
Stroke prevention med awareness, 30 days
Description
accurate knowledge of stroke prevention medications (0=incorrect; 1=correct)
Time Frame
Day 30
Title
Stroke prevention med awareness, 90 days
Description
accurate knowledge of stroke prevention medications (0=incorrect; 1=correct)
Time Frame
Day 90
Title
Patient satisfaction, 7 days
Description
Likert-style survey assessing patient satisfaction and perception of the stroke education
Time Frame
Day 7
Title
Patient satisfaction, 30 days
Description
Likert-style survey assessing patient satisfaction and perception of the stroke education
Time Frame
Day 30
Title
SPER, 7 days
Description
Stroke Patient Education Retention (SPER) survey
Time Frame
Day 7
Title
SPER, 30 days
Description
Stroke Patient Education Retention (SPER) survey
Time Frame
Day 30

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher Favilla, M.D.
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital of the University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Personalized Patient and Caregiver Education After Stroke

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