Health Information Intervention for High Blood Pressure

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: University of Michigan

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Research Team

Eligibility Criteria

This trial is for African American women over 18 years old with high blood pressure who are right-handed. They must not have kidney issues, score at least 22 on a cognitive assessment, or have certain metal implants due to MRI requirements. Pregnant women cannot participate.

Inclusion Criteria

You are right-handed because left-handed individuals may have different brain structure.

You must be right-handed because the study is looking at differences in the brain compared to left-handed people.

I have been diagnosed with high blood pressure.

Exclusion Criteria

You scored less than 22 on a test that measures memory and thinking skills.

You cannot have an fMRI if you have a heart pacemaker, heart defibrillator, metal in the eye, or certain types of metal implants in your body. You are also excluded if you are pregnant.

I have had kidney problems in the past.

Treatment Details

Interventions

• Sharing Intervention (Behavioral Intervention)

Trial Overview The study tests a 'Sharing Intervention' designed to enhance health information behavior and improve self-management of hypertension. It will examine how this affects blood pressure control and brain activity in the participants from the metro-Detroit area.

Participant Groups

Group I: Intervention Experimental Treatment 1 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.

Group II: Control Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

University of Michigan

Lead Sponsor

Trials

1,891

Recruited

6,458,000+

Marschall S. Runge

University of Michigan

Chief Executive Officer since 2015

MD, PhD

Karen McConnell

University of Michigan

Chief Medical Officer since 2020

MD

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Dr. Gary H. Gibbons

National Heart, Lung, and Blood Institute (NHLBI)

Chief Executive Officer since 2012

MD from Harvard Medical School

Dr. James P. Kiley

National Heart, Lung, and Blood Institute (NHLBI)

Chief Medical Officer since 2011

MD from University of California, San Francisco