Clinical trial NCT06119152: Digital Equity for Stroke Approach
Official title: Digital Equity for Stroke Approach Pilot Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke
Blood Pressure, High
Keywords: Telehealth
Digital Health
Remote Device Monitoring
Health Disparities
Afro-Caribbean
Lead sponsor: State University of New York - Downstate Medical Center
Sponsor class: OTHER
First posted: 2023-11-07
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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)

Primary outcomes:
measure: Blood Pressure Change
timeFrame: 9 months
Secondary outcomes:
measure: Number of Blood Pressure readings/week
timeFrame: 9 months
measure: Medication Adherence
timeFrame: 9 months
Other outcomes:
Locations:
city: Brooklyn
country: United States
facility: University Hospital at Downstate
state: New York
Study officials:
affiliation: SUNY Downstate Health Sciences University
name: David R Kaufman, PhD, FACMI
role: PRINCIPAL_INVESTIGATOR
affiliation: SUNY Downstate Health Sciences University
name: Aimee Afable, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References: