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

University of Michigan

Status

Active, not recruiting

Conditions

Hypertension

Treatments

Behavioral: Sharing Intervention

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT04266704

HUM00226482

1K01HL145366-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment

50 estimated patients

Sex

Female

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria: Inclusion criteria are (a) aged >18, (b) clinically diagnosed with hypertension, and (c) right-handed (due to potential differences in brain morphology compared to left-handed individuals).

Exclusion Criteria: Exclusion criteria are (a) history of renal insufficiency, (b) score less than 22 on the Montreal Cognitive Assessment (MOCA), and (c) having one of the following contraindications for fMRI: heart pacemaker, heart defibrillator, metal in the eye, and some types of metal elsewhere within the body such as certain surgical clips for aneurysms in the head, heart valve prostheses, electrodes, and some other implanted devices, pregnant. We require a score of >22 on the MOCA to assure that subjects are able to participate cognitive procedures.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

50 participants in 2 patient groups

Intervention

Experimental group

Description:

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.

Treatment:

Behavioral: Sharing Intervention

Control

Active Comparator group

Description:

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

Treatment:

Behavioral: Sharing Intervention