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

Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04266704
• Other study ID #: HUM00226482
• Secondary ID: 1K01HL145366-01
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 13, 2023
• Est. completion date: November 1, 2024

Study information

• Verified date: May 2024
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Est. completion date: November 1, 2024
• Est. primary completion date: November 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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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Related Conditions & MeSH terms

• Hypertension

Intervention

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).

Locations

Country	Name	City	State
United States	University of Michigan School of Nursing	Ann Arbor	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Brain activity	ability to differentiate between analytic and empathetic prompts, subset of sample	6 months
Secondary	Blood pressure	Systolic and diastolic	Baseline and 6 months
Secondary	Quality of life-PROMIS	Quality of life - PROMIS	Baseline and 6 months