# Effectiveness of Implementing an Intensive Blood Pressure Reduction Intervention on Cognitive Decline in Low-income and Minority Hypertensive Patients

> **NIH NIH R61** · TULANE UNIVERSITY OF LOUISIANA · 2020 · $768,145

## Abstract

Project Summary/Abstract
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 (SPRINT)
showed that an intensive blood pressure (BP) intervention (target systolic BP <120 mmHg) lowered the risk of
cognitive impairment compared to a standard BP intervention (systolic BP target <140 mmHg). The next
important step is to determine how the successful SPRINT intensive blood pressure intervention can be
implemented in a real-world clinic setting to prevent cognitive decline. The overall objective of the proposed
study is to test a multifaceted strategy for implementing an intensive BP intervention protocol adapted from
SPRINT targeting systolic BP <120 mmHg on cognitive decline in racial minority and low-income hypertensive
patients in resource-constrained primary care practices in Louisiana and Mississippi. The RE-AIM (Reach
Effectiveness Adoption Implementation Maintenance) framework has been used to guide the development and
evaluation of the multifaceted implementation strategy, including protocol-based treatment that employs the
SPRINT stepped-care intensive BP management algorithm, dissemination of SPRINT findings, shared-
decision making, team-based collaborative care, BP audit and feedback, home BP monitoring, and patient
health coaching. Building on the ongoing Implementation of Multifaceted Patient-Centered Treatment
Strategies for Intensive Blood Pressure Control (IMPACTS) trial, we will cost-effectively conduct a cluster-
randomized trial in 36 Federally Qualified Health Center clinics that serve low-income populations in Louisiana
and Mississippi. The primary outcome in the proposed trial is the net difference in mean change of global
cognitive composite z-score from baseline to 42 months between the intervention and enhanced usual care
groups. Secondary outcomes include net difference in mean change of executive function and memory
composite z-scores, systolic and diastolic BP, adverse effects, and quality of life. Implementation outcomes,
including acceptability, adaptation, adoption, feasibility, fidelity, penetrance, cost-effectiveness and
sustainability, will also be collected and used to improve intervention delivery during the trial. The proposed
trial, with a sample size of 36 clinics (35 patients/clinic), has 85% statistical power to detect a 0.30 or higher
difference in the global cognitive composite z-score at a 2-sided significance level of 0.05 assuming 20% loss
to follow-up and an intra-cluster correlation of 0.05. In a meta-analysis of 5 clinical trials, the pooled effect size
was 0.35 (95% CI 0.32, 0.38) for the global cognitive composite z-score. This study will generate urgently
needed data on effective, adoptable, and equitable intervention strategies to reduce blood pressure-related
cognitive decline in low-income and minority populations. If proven effective, the implementatio...

## Key facts

- **NIH application ID:** 10045826
- **Project number:** 1R61AG068481-01
- **Recipient organization:** TULANE UNIVERSITY OF LOUISIANA
- **Principal Investigator:** Jiang He
- **Activity code:** R61 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $768,145
- **Award type:** 1
- **Project period:** 2020-08-01 → 2021-07-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10045826

## Citation

> US National Institutes of Health, RePORTER application 10045826, Effectiveness of Implementing an Intensive Blood Pressure Reduction Intervention on Cognitive Decline in Low-income and Minority Hypertensive Patients (1R61AG068481-01). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10045826. Licensed CC0.

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