Clinical trial NCT04797403: Implementation of Multifaceted Patient-Centered Treatment Strategies for Intensive Blood Pressure Control in Minimize Cognitive Decline
Official title: Effectiveness of Implementing an Intensive Blood Pressure Reduction Intervention on Cognitive Decline in Low-Income and Minority Hypertensive Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hypertension
Cognitive Decline
Lead sponsor: Tulane University
Sponsor class: OTHER
Collaborators: name: Wake Forest University
name: National Institute on Aging (NIA)
First posted: 2021-03-15
Enrollment: 1260
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Cluster-randomized trial with randomization at the clinic level
Primary purpose: PREVENTION

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 hypertensive patients in primary care. The proposed 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 implementation strategy for intensive blood pressure reduction could be adapted and scaled up in diverse primary care settings to prevent cognitive decline and clinical dementia.

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 (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-BP) trial, the investigators will cost-effectively conduct a cluster- randomized trial in 40 primary care 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 an average of 36 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, and cost-effectiveness, will also be collected and used to improve intervention delivery during the trial. The proposed trial, with a sample size of 40 clinics (31.5 patients/clinic), has 93% 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 implementation strategy for intensive blood pressure reduction could be adapted and scaled up in diverse primary care settings to prevent cognitive decline and clinical dementia.

Eligibility 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

Primary outcomes:
measure: Net difference in mean change in cognitive decline
timeFrame: Baseline to an average of 36 months
Secondary outcomes:
measure: Net difference in mean change in MoCA score
timeFrame: Baseline to an average of 36 months
measure: Net difference in mean change in executive function
timeFrame: Baseline to an average of 36 months
measure: Net difference in mean change in memory function
timeFrame: Baseline to an average of 36 months
measure: Net difference in mean change in systolic blood pressure
timeFrame: Baseline to an average of 36 months
measure: Net difference in mean change in diastolic blood pressure
timeFrame: Baseline to an average of 36 months
Other outcomes:
measure: Side effects
timeFrame: Baseline to an average of 36 months
measure: Health-related Quality of Life (HRQoL)
timeFrame: Baseline to an average of 36 months
measure: Difference in proportion of patients with adjudicated mild cognitive impairment (MCI) or probable dementia (exploratory outcome)
timeFrame: Baseline to an average of 36 months
Locations:
city: New Orleans
country: United States
facility: Tulane University
state: Louisiana
Study officials:
affiliation: Tulane University
name: Katherine T Mills, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Tulane University
name: Jiang He, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Wake Forest University
name: Jeff D Williamson, MD
role: PRINCIPAL_INVESTIGATOR
References: