Status:
ACTIVE_NOT_RECRUITING
Implementation of Multifaceted Patient-Centered Treatment Strategies for Intensive Blood Pressure Control in Minimize Cognitive Decline
Lead Sponsor:
Tulane University
Collaborating Sponsors:
Wake Forest University
National Institute on Aging (NIA)
Conditions:
Hypertension
Cognitive Decline
Eligibility:
All Genders
40+ years
Phase:
NA
Brief Summary
The study will test a multifaceted strategy for implementing an intensive blood pressure intervention protocol targeting systolic BP \<120 mmHg on cognitive decline in racial minority and low-income h...
Detailed Description
African American and low-income populations bear a disproportionate burden of dementia and have been underrepresented in trials of cognitive impairment. The Systolic Blood Pressure Intervention Trial ...
Eligibility Criteria
Inclusion
- Inclusion Criteria for Primary Care Clinics
- Predominantly managing underserved populations with health disparities (ethnic minorities, low-income groups, and residents of rural areas and inner cities).
- Having electronic medical record systems.
- Serving \>200 hypertension patients (ICD-10-CM I10-I15) during the previous year.
- Not participating in other hypertension control programs
- Not sharing providers or nurses/pharmacists with other participating clinics.
- Inclusion Criteria for Study Participants
- Men or women aged ≥40 years (2/3 of participants ≥60 years) who receive primary care from participating clinics.
- Systolic BP ≥ 140 mmHg at two screening visits for those not taking antihypertensive medication or systolic BP ≥ 130 mmHg at two screening visits for those taking antihypertensive medications
- Pregnant women, women planning to become pregnant in the near future, women of childbearing potential and not practicing birth control, and persons who cannot give informed consent will be excluded.
- No diagnosis of dementia at baseline
- Baseline MoCA score ≥ 10.
- No diagnosis of end-stage renal disease, defined as dialysis or transplantation
- Speak English as first language
- No plans to change to a primary healthcare provider outside of their clinic in the near future
- No individuals unlikely to complete the study, such as those who plan to move out of the study area in the near future and temporary migrant and homeless people
- No immediate family members are staff at their clinic
Exclusion
Key Trial Info
Start Date :
October 22 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2026
Estimated Enrollment :
1306 Patients enrolled
Trial Details
Trial ID
NCT04797403
Start Date
October 22 2019
End Date
August 1 2026
Last Update
August 17 2025
Active Locations (1)
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1
Tulane University
New Orleans, Louisiana, United States, 70112