Digital Equity for Stroke Approach

NCT06119152 | Unknown DMC

• 1 other identifier: 1849255-4
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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:

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

Conditions

Stroke; Blood Pressure, High

Keywords

Telehealth; Digital Health; Remote Device Monitoring; Health Disparities; Afro-Caribbean

Outcome Measures

Primary Outcomes (1)

• Blood Pressure Change

  Blood Pressure (Systolic and Diastolic) will be recorded by telehealth device daily

  9 months

Secondary Outcomes (2)

• Number of Blood Pressure readings/week

  9 months

• Medication Adherence

  9 months

Study Arms (2)

Control

NO INTERVENTION

Usual Care

Intervention

EXPERIMENTAL

The DESA Intervention will use a telehealth device to help the patient take blood pressure daily, and monitor blood pressure management.

Behavioral: DESA

Interventions

DESA BEHAVIORAL

Intervention group is monitored via remote bp monitoring and telehealth device.

Intervention

Eligibility Criteria

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

You may qualify if:

• African American or Afro-Caribbean
• 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)

You may not qualify if:

• Mental illness (severe depression)
• dementia
• Non-English speakers
• aphasia
• severe dysarthria (slurred speech/impediment)

Sponsors & Collaborators

• State University of New York - Downstate Medical Center: lead

Study Sites (1)

University Hospital at Downstate

Brooklyn, New York, 11203, United States

RECRUITING

MeSH Terms

Conditions

Stroke; Hypertension

Condition Hierarchy (Ancestors)

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

Study Officials

• David R Kaufman, PhD, FACMI

  SUNY Downstate Health Sciences University

  PRINCIPAL INVESTIGATOR

• Aimee Afable, PhD, MPH

  SUNY Downstate Health Sciences University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Aimee Afable, PhD, Mph

CONTACT

718-270-6397; aimee.afable@downstate.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2023
• First Posted: November 7, 2023
• Study Start: October 17, 2023
• Primary Completion: October 17, 2024
• Study Completion: February 28, 2025
• Last Updated: November 7, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)