Recruiting

Observational Study

Sponsor:

State University of New York - Downstate Medical Center

Code:

NCT06119152

Conditions

Stroke

Blood Pressure, High

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

DESA

Study Details

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. 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.

Conditions

Stroke

Blood Pressure, High

Study ID

NCT06119152

Start date

Oct 17, 2023

Status verified date

Nov, 2023

Completion date

Feb 28, 2025

Anticipated

Primary completion date

Oct 17, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

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.

Interventions

DESA

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

Primary outcome measure

  • Blood Pressure Change [ Time Frame: 9 months ]

Central Contacts and Locations

Central contacts

Locations

University Hospital at Downstate

Recruiting

Brooklyn, New York, United States, 11203

Contacts

More Information

Sponsor

State University of New York - Downstate Medical Center

Last update posted

Nov 7, 2023

Last verified

Nov, 2023

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by State University of New York - Downstate Medical Center on 2023-11-07.