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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05118503
Other study ID # 833723
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 20, 2021
Est. completion date April 2, 2023

Study information

Verified date October 2023
Source University of Pennsylvania
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 120
Est. completion date April 2, 2023
Est. primary completion date April 2, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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.
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.

Locations

Country Name City State
United States 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 survey Likert-style survey assessing patient satisfaction and perception of the stroke education they received. Day 90
Primary Stroke etiology awareness accurate knowledge of stroke etiology (0=incorrect; 1=correct) Day 90
Primary 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
Primary EuroQOL-VAS validated quality of life metric, with scores of 0-100 Day 90
Secondary Stroke etiology awareness accurate knowledge of stroke etiology (0=incorrect; 1=correct) Day 7
Secondary Stroke etiology awareness accurate knowledge of stroke etiology (0=incorrect; 1=correct) Day 30
Secondary Stroke risk factor awareness. 7 days accurate knowledge of stroke risk factors (0=incorrect; 1=correct) Day 7
Secondary Stroke risk factor awareness, 30 days accurate knowledge of stroke risk factors (0=incorrect; 1=correct) Day 30
Secondary Stroke risk factor awareness, 90 days accurate knowledge of stroke risk factors (0=incorrect; 1=correct) Day 90
Secondary Stroke prevention med awareness, 7 days accurate knowledge of stroke prevention medications (0=incorrect; 1=correct) Day 7
Secondary Stroke prevention med awareness, 30 days accurate knowledge of stroke prevention medications (0=incorrect; 1=correct) Day 30
Secondary Stroke prevention med awareness, 90 days accurate knowledge of stroke prevention medications (0=incorrect; 1=correct) Day 90
Secondary Patient satisfaction, 7 days Likert-style survey assessing patient satisfaction and perception of the stroke education Day 7
Secondary Patient satisfaction, 30 days Likert-style survey assessing patient satisfaction and perception of the stroke education Day 30
Secondary SPER, 7 days Stroke Patient Education Retention (SPER) survey Day 7
Secondary SPER, 30 days Stroke Patient Education Retention (SPER) survey Day 30
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