NCT05118503

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 12, 2021

Completed
8 days until next milestone

Study Start

First participant enrolled

October 20, 2021

Completed
23 days until next milestone

First Posted

Study publicly available on registry

November 12, 2021

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 2, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 2, 2023

Completed
Last Updated

October 26, 2023

Status Verified

October 1, 2023

Enrollment Period

1.4 years

First QC Date

October 12, 2021

Last Update Submit

October 25, 2023

Conditions

Stroke, AcuteStroke, IschemicStroke

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (12)

  • Stroke etiology awareness

    Day 7

  • Stroke etiology awareness

    Day 30

  • Stroke risk factor awareness. 7 days

    Day 7

  • Stroke risk factor awareness, 30 days

    Day 30

  • Stroke risk factor awareness, 90 days

    Day 90

  • +7 more secondary outcomes

Study Arms (2)

Customized education app

ACTIVE COMPARATOR

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

Standard of care discharge education

PLACEBO COMPARATOR

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

Behavioral: Standard of care discharge education

Interventions

Customized educationBEHAVIORAL

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.

Customized education app
Standard of care discharge educationBEHAVIORAL

Half of subjects will be randomized to receive typical discharge education, per the institutional guidelines for standard of care education for stroke patients.

Standard of care discharge education

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (1)

  • Favilla CG, Reehal N, Cummings SR, Burdett R, Stein LA, Shakibajahromi B, Yuan K, Sloane KL, Kasner SE. Personalized Video-Based Educational Platform to Improve Stroke Knowledge: A Randomized Clinical Trial. J Am Heart Assoc. 2024 Aug 6;13(15):e035176. doi: 10.1161/JAHA.124.035176. Epub 2024 Jul 31.

    PMID: 39082426DERIVED

MeSH Terms

Conditions

StrokeIschemic Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Christopher Favilla, M.D.

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Neurology

Study Record Dates

First Submitted

October 12, 2021

First Posted

November 12, 2021

Study Start

October 20, 2021

Primary Completion

April 2, 2023

Study Completion

April 2, 2023

Last Updated

October 26, 2023

Record last verified: 2023-10

Locations

US(1)