Stroke, AcuteNCT06442631
MyStroke for Stroke Survivors and Caregivers
A study testing MyStroke in people with Stroke, Acute and Ischemic Stroke, Acute, run by University of Pennsylvania at 5 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Acute, Ischemic Stroke, Acute
- What is being tested?
- MyStroke
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 690 participants
- Where
- 5 sitesUnited States
- Study dates
- 1 Aug 2026to 1 Mar 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
United States5 sites
Lancaster General Hospital
Lancaster, Pennsylvania, 17602
Danielle Cross, MD, 717-396-9167, Danielle.Cross@pennmedicine.upenn.edu
Penn Presbyterian Medical Center
Philadelphia, Pennsylvania, 19104
Christina Blum, MD, 215-662-8581, Christina.Blum@pennmedicine.upenn.edu
The Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Pennsylvania Hospital
Philadelphia, Pennsylvania, 19107
Daniel Cristancho, MD, 215-662-3606, Daniel.Cristancho@pennmedicine.upenn.edu
Chester County Hospital
West Chester, Pennsylvania, 19380
About this study
Official title: An Individualized Video-based Stroke Education Platform for Stroke Survivors and Caregivers
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:
- Does a personalized, video-based educational platform improve stroke knowledge?
- Does a personalized, video-based educational platform reduce post-discharge health system utilization?
- Do different strategies of nudging improve engagement with educational material after hospital discharge?
Read more
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:
- Receive standard education during the stroke hospitalization
- Complete a survey on the day of hospital discharge to assess their baseline knowledge.
- Half of the subjects will be randomly assigned to also receive access to the personalized stroke education platform on the day of discharge.
- All subjects will complete two follow-up study visits (7 and 90 days after discharge) in order to complete surveys.
Read the 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
- Stroke, Acute, Ischemic Stroke, Acute
- Being tested
- MyStroke
- Keywords
- stroke education, ischemic stroke, stroke knowledge
- Medical subject headings
- Stroke, Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MyStrokeBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Standard stroke education | No 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. |
| MyStroke + standard stroke education | Experimental | 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. Receives: Behavioral: MyStroke |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Stroke Patient Education Retention (SPER) survey
Total score from the 5-question SPER (scale 0-10; higher score reflects better knowledge)
Measured: 90 days
Secondary outcomes (10)
Patient satisfaction with stroke education
5-point Likert-scale (Q: I am satisfied with the quality of my stroke education; Answers range from strongly disagree to strongly agree)
Measured: 90 days
Stroke etiology awareness
The proportion of patients who correctly identify their stroke etiology (multiple choice)
Measured: 90 days
Stroke risk factor awareness
The proportion of patients who correctly identify at least one of their vascular risk factors (select all that apply)
Measured: 90 days
Antithrombotic medication awareness
The proportion of patients who correctly identify all prescribed antithrombotic medications (free response)
Measured: 90 days
Stroke Self-Efficacy Questionnaire (SSEQ)
Total score from the 13 item questionnaire (each item scored 0-10; total score 0-130; higher scores represent higher levels of self-efficacy)
Measured: 90 days
EuroQoL EQ-5D-5L
A standardized measure of health-related quality of life across 5 domains. Each domain is scored using a 5-point ordinal scale (1-5), and the Level Sum Score (LSS) is calculated as the sum of the 5 scores (LSS range is 5-25, lower scores represent higher quality of life).
Measured: 90 days
Medication adherence
This will be assessed based on pharmacy record review to quantify the Proportion of Days Covered (PDC). PDC is calculated by dividing the number of days with medications available by the total number of days in question (scored between 0 - 1; higher numbers represent more favorable adherence)
Measured: 90 days
Emergency Department utilization
The number of Emergency Room visits will be summed in the first 90 days following hospital discharge
Measured: 90 days
Urgent outpatient visits
The number of urgent outpatient visits with primary care and neurologist will be summed in the first 90 days following hospital discharge
Measured: 90 days
Outpatient provider communication
The number of communications with primary care or neurology providers via telephone or provider communication apps will be summed in the first 90 days following hospital discharge
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2024
- Study start1 Aug 2026 (estimated)
- Primary completion30 Nov 2029 (estimated)
- Study completion1 Mar 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke, AcuteStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 690 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christopher Favilla, University of Pennsylvania
- Investigators
- Christopher G Favilla, MD, Principal investigator, Assistant Professor of Neurology at the University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06442631
- Sponsor's protocol ID
- 850498
- Status last verified
- Jan 2026
- First submitted
- 29 May 2024
- Last updated
- 31 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Once a manuscript describing such data is accepted for publication, the deidentified dataset contributing to the publication will be shared publicly using the figshare repository (figshare.com). The availability of shared derived data will be described in publications and presentation.
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Individualized Video-based Stroke Education Platform for Stroke Survivors and Caregivers
- ClinicalTrials.gov ID
- NCT06442631
- Acronym / sponsor ID
- 850498
- Conditions
- Stroke, Acute, Ischemic Stroke, Acute
- Keywords
- stroke education, ischemic stroke, stroke knowledge
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 690 participants (estimated)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 30 Nov 2029 (estimated)
- Study completion
- 1 Mar 2030 (estimated)
- First posted
- 4 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Does a personalized, video-based educational platform improve stroke knowledge?
- Does a personalized, video-based educational platform reduce post-discharge health system utilization?
- 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:
- Receive standard education during the stroke hospitalization
- Complete a survey on the day of hospital discharge to assess their baseline knowledge.
- Half of the subjects will be randomly assigned to also receive access to the personalized stroke education platform on the day of discharge.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard stroke education | No 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. |
| MyStroke + standard stroke education | Experimental | Behavioral: MyStrokeParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MyStrokeMyStroke 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. | Behavioural | MyStroke + standard stroke education |
Primary outcome
The Stroke Patient Education Retention (SPER) survey
Time frame: 90 days
Total score from the 5-question SPER (scale 0-10; higher score reflects better knowledge)
10 secondary outcomes
Patient satisfaction with stroke education
Time frame: 90 days
Stroke etiology awareness
Time frame: 90 days
Stroke risk factor awareness
Time frame: 90 days
Antithrombotic medication awareness
Time frame: 90 days
Stroke Self-Efficacy Questionnaire (SSEQ)
Time frame: 90 days
EuroQoL EQ-5D-5L
Time frame: 90 days
Medication adherence
Time frame: 90 days
Emergency Department utilization
Time frame: 90 days
Urgent outpatient visits
Time frame: 90 days
Outpatient provider communication
Time frame: 90 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2026.
- Individual participant dataSharing planned: Yes. Once a manuscript describing such data is accepted for publication, the deidentified dataset contributing to the publication will be shared publicly using the figshare repository (figshare.com). The availability of shared derived data will be described in publications and presentation.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Christopher G Favilla, MD principal investigator
Assistant Professor of Neurology at the University of Pennsylvania
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MyStroke in people with Stroke, Acute and Ischemic Stroke, Acute, run by University of Pennsylvania at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 31 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christopher G Favilla, MD (2156153727, christopher.favilla@pennmedicine.upenn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Stroke Patient Education Retention (SPER) survey (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2026; AzTrials last refreshed its copy on 26 Oct 2026.