Stroke, AcuteMyStrokeNCT05118503
Personalized Patient and Caregiver Education After Stroke
A study testing Customized education in people with Stroke, Acute and Stroke, Ischemic, run by University of Pennsylvania at 1 site in United States.
Trial summary
This is a randomized pilot trial to evaluate the impact of a customizable stroke education app (vs standard of care discharge education) on patient satisfaction and education retention. The impact of the intervention will be assessed 7, 30, and 90 days post-discharge. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Acute, Stroke, Ischemic, Stroke
- What is being tested?
- Customized education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Oct 2021to 2 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Admitted for ischemic stroke
- At least 18 years old
- Patient or caregiver has access to a smart phone, tablet or computer
- Being discharged to either home or acute rehab
Who cannot join
- Patient or caregivers unable or unwilling to access the customized app with a smartphone, tablet, or computer
- Being discharged to a skilled nursing facility
- moderate-to-severe aphasia at the time of enrollment (as per NIHSS scoring) if patient is being enrolled without a caregiver
Trial locations and contacts
1 site in 1 country.
United States1 site
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
This is a randomized pilot trial to evaluate the impact of a customizable stroke education app (vs standard of care discharge education) on patient satisfaction and education retention. The impact of the intervention will be assessed 7, 30, and 90 days post-discharge.
- Conditions
- Stroke, Acute, Stroke, Ischemic, Stroke
- Being tested
- Customized education, Standard of care discharge education
- 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.
Customized educationBehavioural
Half of subjects will receive access to a customized app that will include brief educational videos that have been selected for each patient based on their medical history. These videos will address stroke etiology, underlying risk factors, and stroke prevention medications.
Standard of care discharge educationBehavioural
Half of subjects will be randomized to receive typical discharge education, per the institutional guidelines for standard of care education for stroke patients.
| Study group | Role | What they receive |
|---|---|---|
| Customized education app | Active comparator | A customized URL-based platform will present brief education videos addressing a patients stroke etiology, risk factors, stroke prevention medications, and post-stroke lifestyle issues. This URL will be made available to the patient and caregiver. Receives: Behavioral: Customized education |
| Standard of care discharge education | Placebo comparator | Standard discharge education is performed by the bedside nurse at the time of hospital discharge. Receives: Behavioral: Standard of care discharge education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient satisfaction survey
Likert-style survey assessing patient satisfaction and perception of the stroke education they received.
Measured: Day 90
Stroke etiology awareness
accurate knowledge of stroke etiology (0=incorrect; 1=correct)
Measured: Day 90
Stroke Patient Education Retention (SPER) survey
Validated measure of stroke patient education as it pertains to their stroke etiology and risk factors with scores of 0-10
Measured: Day 90
EuroQOL-VAS
validated quality of life metric, with scores of 0-100
Measured: Day 90
Secondary outcomes (12)
Stroke etiology awareness
accurate knowledge of stroke etiology (0=incorrect; 1=correct)
Measured: Day 7
Stroke etiology awareness
accurate knowledge of stroke etiology (0=incorrect; 1=correct)
Measured: Day 30
Stroke risk factor awareness. 7 days
accurate knowledge of stroke risk factors (0=incorrect; 1=correct)
Measured: Day 7
Stroke risk factor awareness, 30 days
accurate knowledge of stroke risk factors (0=incorrect; 1=correct)
Measured: Day 30
Stroke risk factor awareness, 90 days
accurate knowledge of stroke risk factors (0=incorrect; 1=correct)
Measured: Day 90
Stroke prevention med awareness, 7 days
accurate knowledge of stroke prevention medications (0=incorrect; 1=correct)
Measured: Day 7
Stroke prevention med awareness, 30 days
accurate knowledge of stroke prevention medications (0=incorrect; 1=correct)
Measured: Day 30
Stroke prevention med awareness, 90 days
accurate knowledge of stroke prevention medications (0=incorrect; 1=correct)
Measured: Day 90
Patient satisfaction, 7 days
Likert-style survey assessing patient satisfaction and perception of the stroke education
Measured: Day 7
Patient satisfaction, 30 days
Likert-style survey assessing patient satisfaction and perception of the stroke education
Measured: Day 30
SPER, 7 days
Stroke Patient Education Retention (SPER) survey
Measured: Day 7
SPER, 30 days
Stroke Patient Education Retention (SPER) survey
Measured: Day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2021
- Study start20 Oct 2021
- Primary completion2 Apr 2023
- Study completion2 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (actual)
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 Favilla, M.D., Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05118503
- Sponsor's protocol ID
- 833723
- Acronym
- MyStroke
- Status last verified
- Oct 2023
- First submitted
- 12 Oct 2021
- Last updated
- 26 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Favilla CG, Reehal N, Cummings SR, Burdett R, Stein LA, Shakibajahromi B, Yuan K, Sloane KL, Kasner SE. Personalized Video-Based Educational Platform to Improve Stroke Knowledge: A Randomized Clinical Trial. J Am Heart Assoc. 2024 Aug 6;13(15):e035176. doi: 10.1161/JAHA.124.035176. Epub 2024 Jul 31.
PubMed 39082426
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personalized Patient and Caregiver Education After Stroke
- ClinicalTrials.gov ID
- NCT05118503
- Acronym / sponsor ID
- MyStroke / 833723
- Conditions
- Stroke, Acute, Stroke, Ischemic, Stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- 20 Oct 2021 (actual)
- Primary completion
- 2 Apr 2023 (actual)
- Study completion
- 2 Apr 2023 (actual)
- First posted
- 12 Nov 2021 (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.
This is a randomized pilot trial to evaluate the impact of a customizable stroke education app (vs standard of care discharge education) on patient satisfaction and education retention. The impact of the intervention will be assessed 7, 30, and 90 days post-discharge.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Customized education app | Active comparator | Behavioral: Customized educationA customized URL-based platform will present brief education videos addressing a patients stroke etiology, risk factors, stroke prevention medications, and post-stroke lifestyle issues. This URL will be made available to the patient and caregiver. |
| Standard of care discharge education | Placebo comparator | Behavioral: Standard of care discharge educationStandard discharge education is performed by the bedside nurse at the time of hospital discharge. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Admitted for ischemic stroke
- At least 18 years old
- Patient or caregiver has access to a smart phone, tablet or computer
- Being discharged to either home or acute rehab
Key exclusion criteria (3 listed)
- Patient or caregivers unable or unwilling to access the customized app with a smartphone, tablet, or computer
- Being discharged to a skilled nursing facility
- moderate-to-severe aphasia at the time of enrollment (as per NIHSS scoring) if patient is being enrolled without a caregiver
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 |
|---|---|---|
| Customized educationHalf of subjects will receive access to a customized app that will include brief educational videos that have been selected for each patient based on their medical history. These videos will address stroke etiology, underlying risk factors, and stroke prevention medications. | Behavioural | Customized education app |
| Standard of care discharge educationHalf of subjects will be randomized to receive typical discharge education, per the institutional guidelines for standard of care education for stroke patients. | Behavioural | Standard of care discharge education |
Primary outcome
Patient satisfaction survey
Time frame: Day 90
Likert-style survey assessing patient satisfaction and perception of the stroke education they received.
Stroke etiology awareness
Time frame: Day 90
accurate knowledge of stroke etiology (0=incorrect; 1=correct)
Stroke Patient Education Retention (SPER) survey
Time frame: Day 90
Validated measure of stroke patient education as it pertains to their stroke etiology and risk factors with scores of 0-10
EuroQOL-VAS
Time frame: Day 90
validated quality of life metric, with scores of 0-100
12 secondary outcomes
Stroke etiology awareness
Time frame: Day 7
Stroke etiology awareness
Time frame: Day 30
Stroke risk factor awareness. 7 days
Time frame: Day 7
Stroke risk factor awareness, 30 days
Time frame: Day 30
Stroke risk factor awareness, 90 days
Time frame: Day 90
Stroke prevention med awareness, 7 days
Time frame: Day 7
Stroke prevention med awareness, 30 days
Time frame: Day 30
Stroke prevention med awareness, 90 days
Time frame: Day 90
Patient satisfaction, 7 days
Time frame: Day 7
Patient satisfaction, 30 days
Time frame: Day 30
SPER, 7 days
Time frame: Day 7
SPER, 30 days
Time frame: Day 30
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2023.
- Derived from this study: PubMed 39082426Favilla CG, Reehal N, Cummings SR, Burdett R, Stein LA, Shakibajahromi B, Yuan K, Sloane KL, Kasner SE. Personalized Video-Based Educational Platform to Improve Stroke Knowledge: A Randomized Clinical Trial. J Am Heart Assoc. 2024 Aug 6;13(15):e035176. doi: 10.1161/JAHA.124.035176. Epub 2024 Jul 31.
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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. This study is not recruiting at the moment.
Christopher Favilla, M.D. principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Customized education in people with Stroke, Acute and Stroke, Ischemic, run by University of Pennsylvania at 1 site 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 4 inclusion and 3 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: finished, as of the sponsor's last update on 26 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient satisfaction survey (time frame: Day 90). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05118503, which also lists 1 linked publication.
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 26 Oct 2023.