MyStroke for Stroke Survivors

Not yet recruiting at 4 trial locations

Overseen By Nichole Gallatti

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Pennsylvania

Disqualifiers: Severe aphasia, Terminal condition, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a personalized video-based education platform, called MyStroke, can improve stroke knowledge and reduce hospital visits after discharge for stroke survivors. Participants will be divided into two groups: one will receive the usual stroke education, while the other will receive both the usual education and access to the new video-based platform. The study will assess participants' stroke knowledge 90 days after hospital discharge. It is suitable for stroke patients or their caregivers who have internet access, speak English or Spanish, and are discharged to home or a rehab facility. As an unphased trial, this study provides a unique opportunity to contribute to innovative educational methods that could enhance recovery and reduce hospital visits for future stroke patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems to focus on education rather than medication changes.

What prior data suggests that this personalized video-based stroke education platform is safe for stroke survivors and caregivers?

Research shows that the safety of the MyStroke platform hasn't been directly studied for negative effects. This tool helps stroke survivors and their caregivers by offering personalized video content about strokes. Since it's not a drug or medical device, typical concerns about side effects don't apply.

As an educational platform, MyStroke is generally considered safe, with no reports of harm from using this type of learning tool. The platform aims to improve understanding of strokes, which can help patients manage their health better.

In summary, MyStroke is a digital tool for education. It doesn't involve medications or physical treatments, so safety concerns are minimal compared to traditional treatments. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about MyStroke because it offers a personalized, video-based approach to stroke education, which could be more engaging and effective than the traditional verbal and booklet methods. Unlike standard care, which relies heavily on face-to-face interactions and printed materials, MyStroke delivers customized content directly to patients' devices, allowing them to access information at their convenience. This platform also includes automated reminders, encouraging ongoing engagement with educational materials even after hospital discharge, potentially leading to better long-term outcomes for stroke survivors.

What evidence suggests that the MyStroke platform is effective for improving stroke knowledge?

Studies have shown that the MyStroke personalized video-based education platform can enhance patient and caregiver satisfaction when learning about stroke. It tailors stroke education to individual needs, making the information easier to understand. One study found a small improvement in understanding stroke information shortly after hospital discharge, but this improvement wasn't significant enough to rule out chance. In this trial, participants in one arm will receive the MyStroke platform alongside standard stroke education. Overall, MyStroke shows promise in making stroke education more engaging and personalized, potentially improving understanding and management of stroke. ^{1 6 7 8 9}

Who Is on the Research Team?

Christopher G Favilla, MD

Principal Investigator

Assistant Professor of Neurology at the University of Pennsylvania

Are You a Good Fit for This Trial?

This trial is for stroke survivors and their caregivers. Participants must have received standard education during hospitalization for a stroke. They should be able to complete surveys on discharge day, and at 7 and 90 days after leaving the hospital.

Inclusion Criteria

I was hospitalized for a stroke that was not caused by bleeding in the brain.

Being discharged to either home or an acute rehabilitation facility

Access to internet enabled device (smartphone, tablet, computer)

Exclusion Criteria

I have severe difficulty speaking or understanding speech.

I had a stroke caused by a surgery.

Resides in a skilled nursing facility prior to admission

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

Education and Discharge

Participants receive standard stroke education during hospitalization and complete a baseline knowledge survey on the day of discharge.

During hospitalization

In-hospital

Post-Discharge Education

Participants receive access to the personalized video-based education platform and automated nudges to engage with educational material.

90 days

Remote engagement

Follow-up

Participants are monitored for stroke knowledge, satisfaction, and health system utilization through surveys and follow-up visits.

90 days

2 visits (7 and 90 days post-discharge)

What Are the Treatments Tested in This Trial?

Interventions

• MyStroke

Trial Overview

Researchers are testing 'MyStroke', a personalized video-based educational platform, against standard stroke education. The study measures if this platform can boost stroke knowledge and reduce health system use post-discharge by comparing two groups: one with standard care, another with additional access to MyStroke.

How Is the Trial Designed?

Group I: MyStroke + standard stroke education Experimental Treatment 1 Intervention

Participants in this arm of the study will receive institutional standard stroke education in addition to access to MyStroke, a personalized video-based education platform. Each participant will receive their personalized page via email or SMS, as per their preference, and they will receive automated nudges to visit educational material after hospital discharge.

Group II: Standard stroke education Active Control 1 Intervention

Participants in this arm of the study will receive institutional standard stroke education during the course of the hospitalization, standardized across the 5 participating sites. Standard education consists of non-standardized verbal bedside education by the care team, a standardized stroke educational booklet, and standardized verbal instructions by the bedside nurse addressing stroke risk factors and medications.

Who Is Running the Clinical Trial?

University of Pennsylvania

Lead Sponsor

Trials

2,118

Recruited

45,270,000+

Published Research Related to This Trial

Younger and less disabled stroke patients tend to have better survival rates and outcomes, while those with dementia or pressure ulcers at admission face worse prognoses.

Starting rehabilitation within 7 days after a stroke significantly improves long-term outcomes compared to starting after 15 days or more, highlighting the importance of early intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early and long-term outcome of rehabilitation in stroke patients: the role of patient characteristics, time of initiation, and duration of interventions. Musicco, M., Emberti, L., Nappi, G., et al.[2022]

The study developed the IschAEmic Stroke Calculator, an online tool that predicts the incidence of adverse events (AEs) in acute stroke trials based on patient characteristics, using data from the Virtual International Stroke Trials Archive (VISTA).

This calculator identifies 48 common AEs and allows researchers to compare predicted incidences with observed data, aiding in the interpretation of trial safety and potentially guiding preventive measures in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Online Tool to Improve Stratification of Adverse Events in Stroke Clinical Trials. Hesse, K., MacIsaac, RL., Abdul-Rahim, AH., et al.[2021]

A comprehensive analysis of adverse events (AEs) from 5775 patients in acute ischemic stroke trials identified 132 expected AEs that accounted for 82.7% of reported events, primarily occurring within 10 days post-stroke.

Patient characteristics such as age, sex, baseline stroke severity, and multimorbidity status can modestly predict the incidence of AEs, helping to stratify patients by their risk for poststroke complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Characteristic adverse events and their incidence among patients participating in acute ischemic stroke trials. Hesse, K., Fulton, RL., Abdul-Rahim, AH., et al.[2022]

In the SENTIS Trial, which included 257 patients with ischemic stroke, the rates of neurological adverse events (AEs) were established, showing intracranial hemorrhage (ICnH) at 27.6%, cerebral edema at 6.6%, neurologic worsening at 18.3%, and new strokes at 4.7%.

Most neurological AEs occurred within defined timeframes, indicating that these rates can serve as benchmarks for safety assessments in future stroke trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neurologic safety event rates in the SENTIS trial control population. Lutsep, HL., Altafullah, IM., Roberts, R., et al.[2013]

Citations

1.

ahajournals.org

ahajournals.org/doi/10.1161/JAHA.124.035176

Personalized Video‐Based Educational Platform to ...

A, 7 days following discharge, patients who received MyStroke reported a nonsignificant improvement in the adequacy of stroke education. B ...

2.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/39082426/

Personalized Video-Based Educational Platform to Improve ...

The MyStroke personalized video-based education platform improved patient and caregiver satisfaction while improving some aspects of personalized stroke ...

3.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06057753

Study Details | NCT06057753 | MyStroke in Chronic Stroke

This is a single-center randomized control trial assessing the impact of a personalized video-based educational platform on patients satisfaction and stroke ...

4.

ctv.veeva.com

ctv.veeva.com/study/mystroke-for-stroke-survivors-and-caregivers

MyStroke for Stroke Survivors and Caregivers

The main questions this study aims to address are: Does a personalized, video-based educational platform improve stroke knowledge?

5.

withpower.com

withpower.com/trial/phase-stroke-acute-stroke-ischemic-6-2025-5e134

MyStroke for Stroke Survivors · Info for Participants

The goal of this multicenter randomized trial is to evaluate the impact of a personalized video-based stroke education platform on patient-centered and ...

6.

ahajournals.org

ahajournals.org/doi/10.1161/JAHA.124.034308

Neighborhood Resources and Health Outcomes Among ...

A higher proportion of survivors died during follow‐up among neighborhoods in the upper quartile of resource density. Study population ...

7.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9357299/

Health outcomes after acute ischemic stroke:retrospective ...

Eighteen patients (16.4%) died during hospitalization; the reported in-hospital mortality rate after acute stroke ranged between 1.8-41% in developing countries ...

8.

cdc.gov

cdc.gov/pcd/issues/2024/24_0113.htm

Behavioral Risk Profiles of Stroke Survivors Among US ...

Living in SBS significantly increased the odds of stroke occurrence. Stroke survivors from SBS reported lower HRQOL and insufficient physical ...

9.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05338697

Validation of Early Prognostic Data for Recovery Outcome ...

Currently, 7 million US stroke survivors have significant disability, more than half with residual motor deficits. Motor function, particularly of the upper ...