Personalized Patient and Caregiver Education After Stroke

Study Overview
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Brief Summary
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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.

Official Title
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Personalized Patient and Caregiver Education After Stroke

Conditions
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Stroke, Acute, Stroke, Ischemic, Stroke

Intervention / Treatment
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* Behavioral: Customized education
* Behavioral: Standard of care discharge education


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Customized education app<br>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<br>* 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.<br>|
| Placebo Comparator: Standard of care discharge education<br>Standard discharge education is performed by the bedside nurse at the time of hospital discharge. | Behavioral: Standard of care discharge education<br>* Half of subjects will be randomized to receive typical discharge education, per the institutional guidelines for standard of care education for stroke patients.<br>|

What is the study measuring?
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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 etiology awareness | accurate knowledge of stroke etiology (0=incorrect; 1=correct) | 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 | 
| EuroQOL-VAS | validated quality of life metric, with scores of 0-100 | Day 90 | 

Secondary Outcome Measures

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