MyStroke for Stroke Survivors and Caregivers

NCT ID: NCT06442631

Last Updated: 2026-01-08

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 690 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-03-01
• Study Completion Date: 2030-03-01

Brief Summary

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.

Detailed Description

Stroke education represents a unique opportunity to empower stroke survivors (and caregivers) to promote self-management, augment adherence, and reduce post-stroke healthcare utilization. Despite being a key quality metric for stroke centers, most patient and caregiver education is poorly retained and a common source of dissatisfaction. In fact, most survivors are unaware of the cause of their stroke, their modifiable risk factors, and how to properly respond to future stroke symptoms. Although there is no gold standard, most centers rely on a combination of bedside verbal communication and standardized printed materials. Prior work has clarified that effective and durable educational interventions benefit from engaging content, personalization, accessibility, and low cost/burden. Retention is very poor during the stroke hospitalization, but this can be overcome by promoting ongoing engagement after discharge.

To that end, our group developed a web-based educational platform (MyStroke) that leverages the electronic health record to personalize video-based educational content for each stroke survivor. Simple but engaging videos are curated to address each patient's stroke etiology, individualized risk factors, prescribed stroke prevention medications, and post-stroke lifestyle issues. This approach transforms point-of-care stroke education, and integrated nudges reveal opportunities for re-education and re-engagement after hospital discharge to achieve a durable impact. In a recent single-center pilot trial, MyStroke improved patient and caregiver satisfaction and improved key elements of stroke knowledge. The objective of this proposal is to build upon our encouraging preliminary experience and conduct a multicenter randomized trial to evaluate the impact of MyStroke on both patient-centered (stroke knowledge, self-efficacy, satisfaction, quality of life) and health system-centered outcomes (medication adherence and health system utilization).

Electronic nudges will leverage principles of behavioral economics (i.e. enhanced nudges) to promote ongoing engagement. Our preliminary data indicate that even bland nudges promote engagement, but here we propose to use both bland nudges and enhanced nudges, such that platform analytics will compare the influence of different nudge types. Use of technology in this context stands to bridge geographic distances, connect stakeholders, and increase access to information, but it important to recognize the potential to exacerbate inequities for elderly patients and those with limited access to technology. Issues of digital inclusivity will be evaluated to reveal opportunities for platform improvement. The MyStroke platform offers a scalable solution stroke education which imposes no burden on the clinical team due to its reliance on a limited number of input fields which can be harvested from the electronic health record to individualized content for each patient.

Conditions

Ischemic Stroke, Acute; Stroke, Acute

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Standard stroke education

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

MyStroke + standard stroke education

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 Type: EXPERIMENTAL

MyStroke

Intervention Type: BEHAVIORAL

MyStroke is a video-based educational platform that curates brief educational videos to inform patients and caregivers about key aspects of their stroke. Upon registering a user, information regarding the patient's stroke etiology, relevant stroke risk factors, and stroke prevention medications are used to populate educational content that is relevant to the individual. Users receive automated nudges to revisit MyStroke after hospital discharge on day 1, 3, 5, 7, and weekly thereafter.

Interventions

MyStroke

MyStroke is a video-based educational platform that curates brief educational videos to inform patients and caregivers about key aspects of their stroke. Upon registering a user, information regarding the patient's stroke etiology, relevant stroke risk factors, and stroke prevention medications are used to populate educational content that is relevant to the individual. Users receive automated nudges to revisit MyStroke after hospital discharge on day 1, 3, 5, 7, and weekly thereafter.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• At least 18 years old
• Admitted to hospital with clinical diagnosis of acute ischemic stroke (imaging confirmation not required)
• Stroke symptom onset within 30 days of enrollment
• Being discharged to either home or an acute rehabilitation facility
• Access to internet enabled device (smartphone, tablet, computer)
• Fluent in either English or Spanish (does not need to be native or primary language)
• Willingness and ability to sign informed consent

Exclusion Criteria

• Severe aphasia (score of ≥2 on NIHSS item 9)
• Ischemic stroke that is attributed to a surgical procedure
• Resides in a skilled nursing facility prior to admission
• Being discharged to skilled nursing facility or long-term acute care facility
• Unwillingness or inability to participate in remote/virtual study visits
• A terminal or advanced condition that raises the possibility the subject may not survive 90 days
• Any other illness or condition that the investigator feels would pose a hazard to the subject from participation in the study

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Pennsylvania

OTHER

Sponsor Role: lead

Responsible Party

Christopher Favilla

Assistant Professor of Neurology at the University of Pennsylvania

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Christopher G Favilla, MD

Role: PRINCIPAL_INVESTIGATOR

Assistant Professor of Neurology at the University of Pennsylvania

Locations

Lancaster General Hospital

Lancaster, Pennsylvania, United States

Penn Presbyterian Medical Center

Philadelphia, Pennsylvania, United States

The Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Pennsylvania Hospital

Philadelphia, Pennsylvania, United States

Chester County Hospital

West Chester, Pennsylvania, United States

Countries

United States

Central Contacts

Christopher G Favilla, MD

Role: CONTACT

christopher.favilla@pennmedicine.upenn.edu

2156153727

Nichole Gallatti

Role: CONTACT

nichole.gallatti@pennmedicine.upenn.edu

2153498651

Facility Contacts

Danielle Cross, MD

Role: primary

Danielle.Cross@pennmedicine.upenn.edu

717-396-9167

Christina Blum, MD

Role: primary

Christina.Blum@pennmedicine.upenn.edu

215-662-8581

Daniel Cristancho, MD

Role: primary

Daniel.Cristancho@pennmedicine.upenn.edu

215-662-3606

Other Identifiers

850498

Identifier Type: -

Identifier Source: org_study_id