Digital Equity for Stroke Approach

Stroke Clinical Trial

— DESA  

Official title:

Digital Equity for Stroke Approach Pilot Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06119152
• Other study ID #: 1849255-4
• Status: Recruiting
• Phase: N/A
• Start date: October 17, 2023
• Est. completion date: February 28, 2025

Study information

• Verified date: November 2023
• Source: State University of New York - Downstate Medical Center
• Contact: Aimee Afable, PhD, Mph
• Phone: 718-270-6397
• Email: aimee.afable[@]downstate.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: February 28, 2025
• Est. primary completion date: October 17, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Blood Pressure, High
• Hypertension
• Stroke

Intervention

Behavioral:
• DESA
Intervention group is monitored via remote bp monitoring and telehealth device.

Locations

Country	Name	City	State
United States	University Hospital at Downstate	Brooklyn	New York

Sponsors (1)

Lead Sponsor	Collaborator
State University of New York - Downstate Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood Pressure Change	Blood Pressure (Systolic and Diastolic) will be recorded by telehealth device daily	9 months
Secondary	Number of Blood Pressure readings/week	Blood Pressure (Systolic and Diastolic) will be recorded by telehealth device daily, so days measured are received from this.	9 months
Secondary	Medication Adherence	Measured by medication adherence survey, at beginning, midpoint, and endpoint of time frame.	9 months