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Completed

NCT Number: NCT04266704

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.

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan School of Nursing

Ann Arbor, Michigan, 48109, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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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Treatment and study plan

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).

Primary outcomes

  1. Brain Activity

    Time frame: 6 months

    fMRI protocol - Each participant was presented the same conditions, in the same order . A fixed sequence design was used because the primary goal was to compare patterns of brain activity between participants. Means are estimated averages of each participant's response to video conditions.

Secondary outcomes

  1. Systolic Blood Pressure

    Time frame: 6 months

    Blood pressure was measured using automated sphygmomanometer based on standardized protocols.

  2. Diastolic Blood Pressure

    Time frame: 6 months

    Blood pressure was measured using automated sphygmomanometer based on standardized protocols.

  3. PROMIS - Mental Health

    Time frame: 6 months

    Health-related quality of life was measured with the PROMIS Global Scale. This 10-item measured the overall physical, mental, and social health of adults. Items range from (1 = never to 5 = always) on a Likert-type scale. Higher scores indicate better quality of life.

  4. PROMIS - Physical Health

    Time frame: 6 months

    Health-related quality of life was measured with the PROMIS Global Scale. This 10-item measured the overall physical, mental, and social health of adults. Items range from (1 = never to 5 = always) on a Likert-type scale. Higher scores indicate better quality of life.

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Feb 12, 2020
Registry last updated
Sep 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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