Implementation of Multifaceted Patient-Centered Treatment Strategies for Intensive Blood Pressure Control in Minimize Cognitive Decline

NCT04797403 | Active Not Recruiting DMC

• 2 other identifiers: R61AG068481R33AG068481
• Study Type: interventional
• Target: 1,306
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension; Cognitive Decline

Outcome Measures

Primary Outcomes (1)

• Net difference in mean change in cognitive decline

  The net difference in mean change of global cognitive composite z-score over an average 36 months between intervention and enhanced usual care groups

  Baseline to an average of 36 months

Secondary Outcomes (5)

• Net difference in mean change in MoCA score

  Baseline to an average of 36 months

• Net difference in mean change in executive function

  Baseline to an average of 36 months

• Net difference in mean change in memory function

  Baseline to an average of 36 months

• Net difference in mean change in systolic blood pressure

  Baseline to an average of 36 months

• Net difference in mean change in diastolic blood pressure

  Baseline to an average of 36 months

Other Outcomes (3)

• Side effects

  Baseline to an average of 36 months

• Health-related Quality of Life (HRQoL)

  Baseline to an average of 36 months

• Difference in proportion of patients with adjudicated mild cognitive impairment (MCI) or probable dementia (exploratory outcome)

  Baseline to an average of 36 months

Study Arms (2)

Intervention

EXPERIMENTAL

The core component of the intervention is protocol-based treatment using the SPRINT intensive BP management algorithm. Implementation strategies include dissemination of SPRINT study findings, team-based collaborative care and shared-decision making, blood pressure audit and feedback, home blood pressure monitoring, and health coaching.

Behavioral: Stepped-care protocol adapted from the SPRINT intensive-treatment algorithm

Enhanced Usual Care

NO INTERVENTION

Enhanced usual care will include an education session on the ACC/AHA hypertension guideline to providers and proper BP measurement to providers and staff at enhanced usual care clinics.Otherwise, no active intervention will take place, and all usual care clinics will follow their routine clinic practice.

Interventions

Stepped-care protocol adapted from the SPRINT intensive-treatment algorithm BEHAVIORAL

The core component of the intervention is protocol-based treatment using the SPRINT intensive BP management algorithm. Implementation strategies include dissemination of SPRINT study findings, team-based collaborative care and shared-decision making, blood pressure audit and feedback, home blood pressure monitoring, and health coaching.

Intervention

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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

Sponsors & Collaborators

• Tulane University: lead
• Wake Forest University: collaborator
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Tulane University

New Orleans, Louisiana, 70112, United States

Location

MeSH Terms

Conditions

Hypertension; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Katherine T Mills, PhD

  Tulane University

  PRINCIPAL INVESTIGATOR

• Jiang He, MD, PhD

  Tulane University

  PRINCIPAL INVESTIGATOR

• Jeff D Williamson, MD

  Wake Forest University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Cluster-randomized trial with randomization at the clinic level

Study Record Dates

• First Submitted: March 8, 2021
• First Posted: March 15, 2021
• Study Start: October 22, 2019
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: August 17, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Study data, including data from baseline and follow-up visits, will be prepared for transmission to the NIH data repository no later than 3 years after the end of the final patient follow-up or 2 years after the main paper of the trial has been published, whichever comes first.

Locations

US (1)