MyStroke for Stroke Survivors

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

690 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The goal of this multicenter randomized trial is to evaluate the impact of a personalized video-based stroke education platform on patient-centered and health system-centered outcomes. The main questions this study aims to address are: 1. Does a personalized, video-based educational platform improve stroke knowledge? 2. Does a personalized, video-based educational platform reduce post-discharge health system utilization? 3. Do different strategies of nudging improve engagement with educational material after hospital discharge? In order to determine the effect of this personalized stroke education strategy, researchers will compare subjects who receive standard stroke education with those who receive the personalized stroke education platform in addition to standard standard education. Patient knowledge will be assessed 90-days after discharge. Study participants will include both stroke patients and caregivers, who will: 1. Receive standard education during the stroke hospitalization 2. Complete a survey on the day of hospital discharge to assess their baseline knowledge. 3. Half of the subjects will be randomly assigned to also receive access to the personalized stroke education platform on the day of discharge. 4. All subjects will complete two follow-up study visits (7 and 90 days after discharge) in order to complete surveys.

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 safety data exists for the treatment MyStroke for stroke survivors?

The research articles discuss adverse events (unwanted side effects) in stroke trials, but they do not provide specific safety data for the treatment MyStroke. They focus on general adverse events in stroke trials, which may help in understanding potential risks. ^{1 2 3 4 5}

How is the MyStroke treatment different from other stroke treatments?

The MyStroke treatment is unique because it focuses on self-management and community-based exercise programs to support stroke survivors, rather than traditional medical or drug-based interventions. This approach emphasizes empowering individuals to manage their recovery and improve their quality of life through personalized support and exercise. ^{6 7 8 9 10}

What data supports the effectiveness of the treatment MyStroke for stroke survivors?

Research suggests that long-term recovery from stroke can be improved with skilled rehabilitation and addressing emotional problems like depression. This implies that treatments focusing on comprehensive post-stroke care, like MyStroke, may help enhance recovery. ^{11 12 13 14 15}

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

Being discharged to either home or an acute rehabilitation facility

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

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. United States pubmed.ncbi.nlm.nih.gov

Cluster Randomized Controlled Trial: Clinical and Cost-Effectiveness of a System of Longer-Term Stroke Care. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Patient-specific recovery patterns over time measured by dependence in activities of daily living after stroke and post-stroke care: the South London Stroke Register (SLSR). [2021]

3. England pubmed.ncbi.nlm.nih.gov

Early computed tomography features in extensive middle cerebral artery territory infarct: prediction of survival. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Post-stroke management concerns and outcomes. [2005]

5. United States 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. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Online Tool to Improve Stratification of Adverse Events in Stroke Clinical Trials. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Characteristic adverse events and their incidence among patients participating in acute ischemic stroke trials. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Perceptions of recurrence risk and behavioural changes among first-ever and recurrent stroke survivors: A qualitative analysis. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Temporal trends in risk of future cardiac events among stroke survivors in the United States. [2012]

10. Denmark pubmed.ncbi.nlm.nih.gov

Neurologic safety event rates in the SENTIS trial control population. [2013]

11. England pubmed.ncbi.nlm.nih.gov

Patients' experience of and participation in a stroke self-management programme, My Life After Stroke (MLAS): a multimethod study. [2022]

12. United States pubmed.ncbi.nlm.nih.gov

Walk the Talk: Current Evidence for Walking Recovery After Stroke, Future Pathways and a Mission for Research and Clinical Practice. [2023]

13. Canada pubmed.ncbi.nlm.nih.gov

The Stroke Recovery in Motion Implementation Planner: Mixed Methods User Evaluation. [2022]

14. United States pubmed.ncbi.nlm.nih.gov

How do stroke survivors with communication difficulties manage life after stroke in the first year? A qualitative study. [2020]

15. Switzerland pubmed.ncbi.nlm.nih.gov

Poststroke knowledge and symptom awareness: a global issue for secondary stroke prevention. [2018]