Digital Equity for Stroke Approach (DESA)

Digital Equity for Stroke Approach Pilot Study

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:

1. Assess and build setting, community, and user fit of DESA, leveraging qualitative methods and simulation telehealth encounters between the patient and neurologist.
2. 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.
3. 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.

Study Overview

• Status: Recruiting
• Conditions: Stroke; Blood Pressure, High
• Intervention / Treatment: Behavioral: DESA

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Aimee Afable, PhD, Mph; Phone Number: 718-270-6397; Email: aimee.afable@downstate.edu

Study Locations

• United States
  • New York
    • Brooklyn, New York, United States, 11203
      • Recruiting
      • University Hospital at Downstate
      • Contact: Steven Levine, MD; Phone Number: 718-270-3188; Email: steven.levine@downstate.edu
      • Contact: Nadege Gilles, MPH; Phone Number: 718-270-7786; Email: nadege.gilles@downstate.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

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

Collaborators and Investigators

• Sponsor: State University of New York - Downstate Medical Center
• Investigators: Principal Investigator: David R Kaufman, PhD, FACMI, SUNY Downstate Health Sciences University; Principal Investigator: Aimee Afable, PhD, MPH, SUNY Downstate Health Sciences University

Study record dates

Study Major Dates

• Study Start (Actual): October 17, 2023
• Primary Completion (Estimated): October 17, 2024
• Study Completion (Estimated): February 28, 2025

Study Registration Dates

• First Submitted: July 11, 2023
• First Submitted That Met QC Criteria: November 2, 2023
• First Posted (Actual): November 7, 2023

Study Record Updates

• Last Update Posted (Actual): November 7, 2023
• Last Update Submitted That Met QC Criteria: November 2, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Telehealth; Digital Health; Health Disparities; Afro-Caribbean; Remote Device Monitoring
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke; Hypertension
• Other Study ID Numbers: 1849255-4

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No