RECRUITING

Digital Equity for Stroke Approach

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Digital Equity for Stroke Approach Pilot Study

Quick Facts

Study Start:2023-10-17
Study Completion:2025-02-28
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06119152

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * African American or Afro-Caribbean
  2. * 18 years or over
  3. * Experienced a stroke in the last 6 years
  4. * A score between 2 and 4 on the Modified Rankin Scale2
  5. * Has a formal or informal caregiver (e.g., relative, health aide or other) to assist them in activities of daily living
  6. * Has a primary care physician at University Hospital of Brooklyn (UHB)
  1. * Mental illness (severe depression)
  2. * dementia
  3. * Non-English speakers
  4. * aphasia
  5. * severe dysarthria (slurred speech/impediment)

Contacts and Locations

Study Contact

Aimee Afable, PhD, Mph
CONTACT
718-270-6397
aimee.afable@downstate.edu

Principal Investigator

David R Kaufman, PhD, FACMI
PRINCIPAL_INVESTIGATOR
SUNY Downstate Health Sciences University
Aimee Afable, PhD, MPH
PRINCIPAL_INVESTIGATOR
SUNY Downstate Health Sciences University

Study Locations (Sites)

University Hospital at Downstate
Brooklyn, New York, 11203
United States

Collaborators and Investigators

Sponsor: State University of New York - Downstate Medical Center

  • David R Kaufman, PhD, FACMI, PRINCIPAL_INVESTIGATOR, SUNY Downstate Health Sciences University
  • Aimee Afable, PhD, MPH, PRINCIPAL_INVESTIGATOR, SUNY Downstate Health Sciences University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-10-17
Study Completion Date2025-02-28

Study Record Updates

Study Start Date2023-10-17
Study Completion Date2025-02-28

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • Stroke
  • Blood Pressure, High