Building a Multidisciplinary Research Program to Address Hypertension Disparities: Exploring the Neurocognitive Mechanisms of a Self-Management Intervention for African American Women

NCT04266704 | Completed DMC

• 2 other identifiers: HUM002264821K01HL145366-01
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this project is to develop and pilot test a research protocol to assess the influence of a health information behavior enhanced intervention on self-management, blood pressure control, and brain activity in African American women with hypertension. This work will identify characteristics of African American women that are associated with improved self-management and decreased blood pressure, and subsequent reduction of risk of heart disease and premature death. The results of this project will have direct impact in informing interventions to improve blood pressure control, by advancing our knowledge of brain activity associated with behavior change in African American women with hypertension in the metro-Detroit area, and ultimately everywhere.

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

• Brain activity

  ability to differentiate between analytic and empathetic prompts, subset of sample

  6 months

Secondary Outcomes (2)

• Blood pressure

  Baseline and 6 months

• Quality of life-PROMIS

  Baseline and 6 months

Study Arms (2)

Intervention

EXPERIMENTAL

Along with providing education on a low sodium diet (Dietary Approaches to Stop Hypertension or DASH), exercise, and medication adherence, the intervention arm is designed to promote information sharing and stimulate broad cortical neural networks, the default mode (DMN), which focuses on emotion-management and self-awareness.

Behavioral: Sharing Intervention

Control

ACTIVE COMPARATOR

education on a low sodium diet (Dietary Approaches to Stop Hypertension or DASH), exercise, and medication adherence

Behavioral: Sharing Intervention

Interventions

Sharing Intervention BEHAVIORAL

intervention includes both analytic and socioemotional components related to self-management of hypertension and is specifically targeted to African American women. Along with providing education on lifestyle changes to lower blood pressure, DASH diet, exercise, and medication adherence (analytic components), the intervention is designed to promote social activities around blood pressure self-management, in particular, sharing blood pressure management information with peers (socioemotional components).

Control; Intervention

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: African American women
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• University of Michigan: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

University of Michigan School of Nursing

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: February 10, 2020
• First Posted: February 12, 2020
• Study Start: June 13, 2023
• Primary Completion: April 25, 2025
• Study Completion: April 25, 2025
• Last Updated: May 28, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)