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

Hypertension Clinical Trial

— IMPACTS-MIND  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04797403
• Other study ID #: R61AG068481
• Status: Recruiting
• Phase: Phase 3
• Start date: October 22, 2019
• Est. completion date: July 2025

Study information

• Verified date: May 2023
• Source: Tulane University
• Contact: Erin Peacock, PhD
• Phone: 504-988-1075
• Email: epeacoc[@]tulane.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The proposed 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.

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 46 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 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, and cost-effectiveness, will also be collected and used to improve intervention delivery during the trial. The proposed trial, with a sample size of 46 clinics (20 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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 920
• Est. completion date: July 2025
• Est. primary completion date: July 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Decline
• Cognitive Dysfunction
• Hypertension

Intervention

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

Locations

Country	Name	City	State
United States	Tulane University	New Orleans	Louisiana

Sponsors (3)

Lead Sponsor	Collaborator
Tulane University	National Institute on Aging (NIA), Wake Forest University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Side effects	Difference between the intervention and usual care group in frequency of side effects (collected via detailed questionnaire) over an average 42 months.	Baseline to an average of 42 months
Other	Health-related Quality of Life (HRQoL)	Difference between the intervention and usual care group in mean change in health-related quality of life (measured using the 12-Item Short Form Survey) over an average 42 months.	Baseline to an average of 42 months
Other	Difference in proportion of patients with adjudicated mild cognitive impairment (MCI) or probable dementia (exploratory outcome)	Difference in adjudicated MCI and probable dementia at the termination visit between the intervention and usual care group. Based on pre-defined MoCA cutpoints, suspected cases of dementia/MCI will be randomly assigned to two adjudicators, blinded to treatment assignment, with expertise in dementia for review. Data used in the adjudication will include all available cognitive test data, functional assessment, and additional data including demographic information and medical records.	Baseline to an average of 42 months
Primary	Net difference in mean change in cognitive decline	The net difference in mean change of global cognitive composite z-score over an average 42 months between intervention and enhanced usual care groups	Baseline to an average of 42 months
Secondary	Net difference in mean change in MoCA score	Difference between the intervention and usual care group in mean change in Montreal Cognitive Assessment (MoCA) over an average 42 months.	Baseline to an average of 42 months
Secondary	Net difference in mean change in executive function	Difference between the intervention and usual care group in mean change in executive function composite z-score (calculated from average of z-scores from individual tests: DSC, Trails A & B, DST, Category Fluency) over an average 42 months.	Baseline to an average of 42 months
Secondary	Net difference in mean change in memory function	Difference between the intervention and usual care group in mean change in memory composite z-score (calculated from average of z-scores from individual tests: MoCA immediate & delayed word recall, HVLT-R immediate recall) over an average 42 months.	Baseline to an average of 42 months
Secondary	Net difference in mean change in systolic blood pressure	Difference between the intervention and usual care group in mean change in systolic blood pressure over an average 42 months.	Baseline to an average of 42 months
Secondary	Net difference in mean change in diastolic blood pressure	Difference between the intervention and usual care group in mean change in diastolic blood pressure over an average 42 months.	Baseline to an average of 42 months