Stroke (CVA) or TIA Clinical Trial
— MOSESOfficial title:
Multiple Organized Systems for Engaging Stroke (MOSES)
NCT number | NCT05780060 |
Other study ID # | 2021-13414 |
Secondary ID | |
Status | Withdrawn |
Phase | N/A |
First received | |
Last updated | |
Start date | April 1, 2023 |
Est. completion date | March 1, 2024 |
Verified date | April 2023 |
Source | Montefiore Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Despite decades of national declines in stroke incidence, racial/ethnic and socioeconomic disparities in stroke prevalence and care remain pervasive and the gap in these disparities is widening. Those who identify as African American (AA) or Hispanic are 2-3 times more likely to have a stroke when compared to those who identify as non-Hispanic White (NHW) and are also less likely to receive guideline-based medical therapy (e.g. mechanical thrombectomy, intravenous thrombolysis, discharge antithrombotic/anticoagulant, smoking cessation education) after their stroke. Additionally, people living in underserved communities with high local social deprivation indices and decreased community-level healthcare access, have an increased population-level risk of stroke. These inequities are likely multi-factorial and in large part related to decreased access to health promotion and preventive care services, as well as social/economic constraints impeding patients' access and compliance with medical treatment recommendations. Innovations in patient-facing digital health technologies, such as telemedicine, remote patient monitoring (RPM), and patient-facing smart phone applications could help bridge the gaps in post stroke care in marginalized communities by providing more accessible, convenient and perhaps effective, health care services. A recent secondary stroke prevention trial with predominantly African American and Hispanic participants compared blood pressure control measured by RPM combined with telehealth support vs. standard office-based follow up and found improved adherence and risk factor control in the digitally assisted group. However, there is limited knowledge around the patient and provider-level barriers, and supportive and educational resources needed to translating these and other similar findings into practice, especially in high-risk communities. Importantly, the same barriers to adopting digitally assisted care delivery during transitions of care and in the management of high-risk groups are shared across a number of episodic (e.g. ACS), acute on chronic (e.g. asthma, COPD, heart failure, DKA) and chronic diseases (e.g. hypertension, renal failure).
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | March 1, 2024 |
Est. primary completion date | January 1, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Diagnosis of recent TIA (<6 months) or minor stroke - discharged to home with stroke clinic follow up planned - modified Rankin score <3 at time of discharge. Exclusion Criteria: - Cognitive impairment limiting compliance with the intervention - Modified Rankin score >2 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Montefiore Medical Center |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | patient satisfaction | Telehealth Usability Questionnaire (TUQ) This is a 21 question survey which assesses 5 domains (usefulness, ease of use, reliability, effectiveness, satisfaction) of patient's satisfaction and usability of remote monitoring.
Each question is ranked from 1-7 with 7 defined as "strong agreement/satisfaction" Min score is 21, max score is 147. The higher the score the greater the satisfaction/usability |
1 month | |
Primary | provider satisfaction | Telehealth Usability Questionnaire (TUQ) This is a 21 question survey which assesses 5 domains (usefulness, ease of use, reliability, effectiveness, satisfaction) of a provider's satisfaction and usability of remote monitoring.
Each question is ranked from 1-7 with 7 defined as "strong agreement/satisfaction" Min score is 21, max score is 147 The higher the score the greater the satisfaction/usability |
1 month | |
Primary | compliance with medical follow up and treatment plan | defined by the number of telehealth visits over the course of the study Min is 0 and max is 10 | 1 month | |
Primary | medical knowledge of stroke symptoms | ability to identify the symptoms of stroke defined by the BEFAST Criteria. Min is 0, max is score 6, with higher score defined as having greater medical knowledge of stroke symptoms | 1 month | |
Secondary | BP control | the weekly average systolic, diastolic blood pressure, and mean arterial pressure over the course of the study. All weekly measures will be averaged. Any erroneous values that fall 2 standard deviations away from the mean will be excluded.
there is no min or max. |
1 month | |
Secondary | readmission rate | readmission rate for stroke or other acute illness at 30 days | 30 days |
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