DESA: Digital Equity for Stroke Approach

• Sponsor: State University of New York - Downstate Medical Center (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT06119152
• Collaborator: (none)
• Enrollment: 80
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 16.4
• Patients Per Site Per Month: 4.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Stroke; Blood Pressure, High	Behavioral: DESA	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 80 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Digital Equity for Stroke Approach Pilot Study
• Actual Study Start Date: Oct 17, 2023
• Anticipated Primary Completion Date: Oct 17, 2024
• Anticipated Study Completion Date: Feb 28, 2025

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Blood Pressure Change [9 months]

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

Secondary Outcome Measures

1. Number of Blood Pressure readings/week [9 months]

   Blood Pressure (Systolic and Diastolic) will be recorded by telehealth device daily, so days measured are received from this.

2. Medication Adherence [9 months]

   Measured by medication adherence survey, at beginning, midpoint, and endpoint of time frame.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospital at Downstate	Brooklyn	New York	United States	11203

Sponsors and Collaborators

• 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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: State University of New York - Downstate Medical Center
• ClinicalTrials.gov Identifier: NCT06119152
• Other Study ID Numbers: 1849255-4
• First Posted: Nov 7, 2023
• Last Update Posted: Nov 7, 2023
• Last Verified: Nov 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by State University of New York - Downstate Medical Center: Telehealth; Digital Health; Remote Device Monitoring; Health Disparities; Afro-Caribbean
• Additional relevant MeSH terms: Stroke; Hypertension

Study Results

No Results Posted as of Nov 7, 2023