Digital Equity for Stroke Approach

Study Overview
=================
Brief Summary
-----------------
A community-academic partnership composed of a State University of New York (SUNY) Downstate Health Sciences University inter-disciplinary team of scientists (representing public health, medical informatics, vascular neurology/stroke center) and the Digital Equity Community Advisory Board (DECA) will guide our research. This is an NIH R21 pilot study. Our Specific Aims are designed to inform the sample design and research priorities for a larger NIH R01 experimental study and to serve as a platform for similar studies with other health conditions. We propose a mixed-methods study design with the following aims: Assess and build setting, community, and user fit of DESA, leveraging qualitative methods and simulation telehealth encounters between the patient and neurologist. Conduct a 9-month pilot randomized control trial (RCT) of DESA in a Central Brooklyn stroke population to examine the feasibility and preliminary efficacy. We will randomize 50 adults to DESA and 30 to usual care. The primary outcome will be BP control. Secondary outcomes include the number of BP measurements and medication compliance. Our primary hypothesis is that patients randomized to the DESA will significantly reduce systolic blood pressure at 9 months. Examine barriers and facilitators to the adoption and integration of DESA into routine stroke care utilizing key informant interviews and user satisfaction surveys with neurologists and intervention participants.

Official Title
-----------------
Digital Equity for Stroke Approach Pilot Study

Conditions
-----------------
Stroke, Blood Pressure, High

Intervention / Treatment
-----------------
* Behavioral: DESA


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: African American or Afro-Caribbean 18 years or over Experienced a stroke in the last 6 years A score between 2 and 4 on the Modified Rankin Scale2 Has a formal or informal caregiver (e.g., relative, health aide or other) to assist them in activities of daily living Has a primary care physician at University Hospital of Brooklyn (UHB) Exclusion Criteria: Mental illness (severe depression) dementia Non-English speakers aphasia severe dysarthria (slurred speech/impediment)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>Usual Care | |
| Experimental: Intervention<br>The DESA Intervention will use a telehealth device to help the patient take blood pressure daily, and monitor blood pressure management. | Behavioral: DESA<br>* Intervention group is monitored via remote bp monitoring and telehealth device.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood Pressure Change | Blood Pressure (Systolic and Diastolic) will be recorded by telehealth device daily | 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Blood Pressure readings/week | Blood Pressure (Systolic and Diastolic) will be recorded by telehealth device daily, so days measured are received from this. | 9 months | 
| Medication Adherence | Measured by medication adherence survey, at beginning, midpoint, and endpoint of time frame. | 9 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Telehealth, Digital Health, Remote Device Monitoring, Health Disparities, Afro-Caribbean