Intensive blood pressure control to reduce cognitive decline in underserved populations
Effectiveness of Implementing an Intensive Blood Pressure Reduction Intervention on Cognitive Decline in Low-Income and Minority Hypertensive Patients
This study is testing a new way to lower blood pressure in underserved patients to see if it can help prevent memory problems and dementia.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1260 (estimated) |
| Ages | 40 Years and up |
| Sex | All |
| Sponsor | Tulane University Academic / other |
| Locations | 1 site (New Orleans, Louisiana) |
| Trial ID | NCT04797403 on ClinicalTrials.gov |
What this trial studies
This study tests a multifaceted strategy for implementing an intensive blood pressure intervention protocol aimed at achieving a systolic BP of less than 120 mmHg. It focuses on racial minority and low-income hypertensive patients in primary care settings, particularly in Louisiana and Mississippi. The approach is based on the successful SPRINT trial and employs a stepped-care protocol, shared decision-making, and patient health coaching to enhance treatment adoption and effectiveness. The goal is to generate data on equitable intervention strategies that can be adapted and scaled in diverse primary care environments to prevent cognitive decline and dementia.
Who should consider this trial
Good fit: Ideal candidates include men and women aged 40 and older with hypertension who receive care from participating clinics.
Not a fit: Patients who are pregnant, planning to become pregnant, or unable to provide informed consent may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly reduce the risk of cognitive decline and dementia in underserved populations.
How similar studies have performed: Previous studies, such as the SPRINT trial, have shown success with intensive blood pressure control, making this approach promising for further implementation.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
New Orleans, Louisiana
- Tulane University — New Orleans, Louisiana, United States (Recruiting)
Study contacts
- Principal investigator: Katherine T Mills, PhD — Tulane University
- Study coordinator: Erin Peacock, PhD
- Email: epeacoc@tulane.edu
- Phone: 504-988-1075
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.