MyStroke for Stroke Survivors and Caregivers

Stroke, Acute Clinical Trial

Official title:

An Individualized Video-based Stroke Education Platform for Stroke Survivors and Caregivers

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06442631
• Other study ID #: 850498
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2025
• Est. completion date: March 31, 2029

Study information

• Verified date: May 2024
• Source: University of Pennsylvania
• Contact: Christopher G Favilla, MD
• Phone: 2156153727
• Email: christopher.favilla[@]pennmedicine.upenn.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 586
• Est. completion date: March 31, 2029
• Est. primary completion date: March 31, 2029
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Ischemic Stroke
• Stroke
• Stroke, Acute

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	Lancaster General Hospital	Lancaster	Pennsylvania
United States	Penn Presbyterian Medical Center	Philadelphia	Pennsylvania
United States	Pennsylvania Hospital	Philadelphia	Pennsylvania
United States	The Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania
United States	Chester County Hospital	West Chester	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The Stroke Patient Education Retention (SPER) survey (7 days)	Total score from the 5-question SPER (scale 0-10; higher score reflects better knowledge)	7 days
Other	Patient satisfaction with stroke education (7 days)	5-point Likert-scale (Q: I am satisfied with the quality of my stroke education; Answers range from strongly disagree to strongly agree)	7 days
Other	Stroke etiology awareness (7 days)	The proportion of patients who correctly identify their stroke etiology (multiple choice)	7 days
Other	Stroke risk factor awareness (7 days)	The proportion of patients who correctly identify at least one of their vascular risk factors (select all that apply)	7 days
Other	Antithrombotic medication awareness (7 days)	The proportion of patients who correctly identify all prescribed antithrombotic medications (free response)	7 days
Other	Stroke Self-Efficacy Questionnaire (SSEQ) (7 days)	Total score from the 13 item questionnaire (each item scored 0-10; total score 0-130; higher scores represent higher levels of self-efficacy)	7 days
Other	EuroQoL EQ-5D-5L (7 days)	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).	7 days
Primary	The Stroke Patient Education Retention (SPER) survey	Total score from the 5-question SPER (scale 0-10; higher score reflects better knowledge)	90 days
Secondary	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)	90 days
Secondary	Stroke etiology awareness	The proportion of patients who correctly identify their stroke etiology (multiple choice)	90 days
Secondary	Stroke risk factor awareness	The proportion of patients who correctly identify at least one of their vascular risk factors (select all that apply)	90 days
Secondary	Antithrombotic medication awareness	The proportion of patients who correctly identify all prescribed antithrombotic medications (free response)	90 days
Secondary	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)	90 days
Secondary	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).	90 days
Secondary	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)	90 days
Secondary	Emergency Department utilization	The number of Emergency Room visits will be summed in the first 90 days following hospital discharge	90 days
Secondary	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	90 days
Secondary	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	90 days