Ignite Creation Date:
2024-05-06 @ 7:44 PM
Last Modification Date:
2024-10-26 @ 3:13 PM
Study NCT ID:
NCT06119152
Status:
RECRUITING
Last Update Posted:
2023-11-07
First Post:
2023-07-11
Brief Title:
Digital Equity for Stroke Approach
Sponsor:
State University of New York - Downstate Medical Center
Organization:
State University of New York - Downstate Medical Center
Study Overview
Official Title:
Digital Equity for Stroke Approach Pilot Study
Status:
RECRUITING
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DESA
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 neurologystroke 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None