Multiple Organized Systems for Engaging Stroke (MOSES)

NCT05780060 | Withdrawn DMC

• 1 other identifier: 2021-13414
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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).

Conditions

Stroke (CVA) or TIA

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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 Outcomes (2)

• BP control

  1 month

• readmission rate

  30 days

Study Arms (2)

Intervention arm

EXPERIMENTAL

standard stroke clinic follow, combined with remote patient blood pressure monitoring and an added patient-facing smartphone application with educational modules and adherence incentives (n=30).

Behavioral: Standard of care, RPM and digital feedback

Control arm

ACTIVE COMPARATOR

standard stroke clinic follow up combined with remote blood pressure monitoring

Behavioral: Standard of care and RPM only

Interventions

Standard of care, RPM and digital feedback BEHAVIORAL

Standard stroke follow up, RPM and a patient facing smartphone application containing real time BP feedback, educational models, treatment adherence push notification reminders, digital education and digital incentives (n=30). Outcomes will include recruitment, retention and follow up metrics, self-reported adherence to medication regimens and life-style recommendations, patient engagement with RPM data and patient-facing application, cost-effectiveness of the interventions and changes in blood pressure as well as biomarkers like LDL and Hemoglobin A1C.

Intervention arm

Standard of care and RPM only BEHAVIORAL

Standard stroke clinic follow up and remote blood pressure monitoring (n=30). Outcomes will include qualitative patient and provider experiences with the TBIs including barriers and facilitators to the use of RPM and patient-facing application in the study population

Control arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Cognitive impairment limiting compliance with the intervention
• Modified Rankin score \>2

Sponsors & Collaborators

• Montefiore Medical Center: lead

MeSH Terms

Conditions

Stroke

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Charles Esenwa, MD

  Montefiore Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study team will conduct a pragmatic comparative effectiveness study comparing standard stroke clinic follow up combined with RPM to aid with blood pressure management (n=30) versus standard stroke clinic follow, RPM and an added patient-facing smartphone application with educational modules and adherence incentives (n=30). Outcomes will include recruitment, retention and follow up metrics, self-reported adherence to medication regimens and life-style recommendations, patient engagement with RPM data and patient-facing application, cost-effectiveness of the interventions and changes in blood pressure as well as biomarkers such as HbA1c or LDL cholesterol levels. We hypothesize that RPM combined with a patient-facing application will improve patient reported and clinical outcomes of interest in the post-stroke transition of care setting.

Study Record Dates

• First Submitted: February 17, 2023
• First Posted: March 22, 2023
• Study Start: April 1, 2023
• Primary Completion: January 1, 2024
• Study Completion: March 1, 2024
• Last Updated: April 13, 2023

Record last verified: 2023-04