Personalized Patient and Caregiver Education After Stroke

NCT ID: NCT05118503

Last Updated: 2023-10-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-20

Study Completion Date

2023-04-02

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Stroke, Acute Stroke, Ischemic Stroke

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type ACTIVE_COMPARATOR

Customized education

Intervention Type BEHAVIORAL

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

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

Group Type PLACEBO_COMPARATOR

Standard of care discharge education

Intervention Type BEHAVIORAL

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Pennsylvania

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Christopher Favilla

Assistant Professor of Neurology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Christopher Favilla, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 39082426 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

833723

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Stroke Caregiver Empowerment
NCT02772445 COMPLETED NA