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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Hypertension
• Intervention / Treatment: Behavioral: Sharing Intervention

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lenette M Jones, PhD; Phone Number: 734-763-1371; Email: lenettew@umich.edu

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan School of Nursing

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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).

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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.

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Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; 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; 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).
Active Comparator: Control; education on a low sodium diet (Dietary Approaches to Stop Hypertension or DASH), exercise, and medication adherence	Behavioral: Sharing Intervention; 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Brain activity	ability to differentiate between analytic and empathetic prompts, subset of sample	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood pressure	Systolic and diastolic	Baseline and 6 months
Quality of life-PROMIS	Quality of life - PROMIS	Baseline and 6 months

Collaborators and Investigators

• Sponsor: University of Michigan
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI)

Study record dates

Study Major Dates

• Study Start (Actual): June 13, 2023
• Primary Completion (Estimated): June 30, 2024
• Study Completion (Estimated): October 31, 2024

Study Registration Dates

• First Submitted: February 10, 2020
• First Submitted That Met QC Criteria: February 10, 2020
• First Posted (Actual): February 12, 2020

Study Record Updates

• Last Update Posted (Actual): April 5, 2024
• Last Update Submitted That Met QC Criteria: April 4, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: HUM00226482; 1K01HL145366-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No