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Digital Equity for Stroke Approach

Digital Equity for Stroke Approach Pilot Study

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06119152
Acronym
DESA
Enrollment
80
Registered
2023-11-07
Start date
2023-10-17
Completion date
2025-02-28
Last updated
2023-11-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Blood Pressure, High, Stroke

Keywords

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

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.

Interventions

BEHAVIORALDESA

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

Sponsors

State University of New York - Downstate Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Blood Pressure Change9 monthsBlood Pressure (Systolic and Diastolic) will be recorded by telehealth device daily

Secondary

MeasureTime frameDescription
Number of Blood Pressure readings/week9 monthsBlood Pressure (Systolic and Diastolic) will be recorded by telehealth device daily, so days measured are received from this.
Medication Adherence9 monthsMeasured by medication adherence survey, at beginning, midpoint, and endpoint of time frame.

Countries

United States

Contacts

Primary ContactAimee Afable, PhD, Mph
aimee.afable@downstate.edu718-270-6397

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026