Back to resultsBuilding a Multidisciplinary Research Program to Address Hypertension Disparities: Exploring the Neurocognitive Mechanisms of a Self-Management Intervention for African American Women
Primary Purpose
Hypertension
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Sharing Intervention
Sponsored by
About this trial
This is an interventional treatment trial for Hypertension
Eligibility 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).
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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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Sites / Locations
- University of Michigan School of NursingRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Intervention
Control
Arm 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.
education on a low sodium diet (Dietary Approaches to Stop Hypertension or DASH), exercise, and medication adherence
Outcomes
Primary Outcome Measures
Brain activity
ability to differentiate between analytic and empathetic prompts, subset of sample
Secondary Outcome Measures
Blood pressure
Systolic and diastolic
Quality of life-PROMIS
Quality of life - PROMIS
Full Information
NCT ID
NCT04266704
First Posted
February 10, 2020
Last Updated
October 20, 2023
Sponsor
University of Michigan
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
1. Study Identification
Unique Protocol Identification Number
NCT04266704
Brief Title
Building a Multidisciplinary Research Program to Address Hypertension Disparities: Exploring the Neurocognitive Mechanisms of a Self-Management Intervention for African American Women
Official Title
Building a Multidisciplinary Research Program to Address Hypertension Disparities: Exploring the Neurocognitive Mechanisms of a Self-Management Intervention for African American Women
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 13, 2023 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
March 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm 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.
Arm Title
Control
Arm Type
Active Comparator
Arm Description
education on a low sodium diet (Dietary Approaches to Stop Hypertension or DASH), exercise, and medication adherence
Intervention Type
Behavioral
Intervention Name(s)
Sharing Intervention
Intervention Description
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 Outcome Measure Information:
Title
Brain activity
Description
ability to differentiate between analytic and empathetic prompts, subset of sample
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Blood pressure
Description
Systolic and diastolic
Time Frame
Baseline and 6 months
Title
Quality of life-PROMIS
Description
Quality of life - PROMIS
Time Frame
Baseline and 6 months
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
African American women
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
-
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lenette M Jones, PhD
Phone
734-763-1371
Email
lenettew@umich.edu
Facility Information:
Facility Name
University of Michigan School of Nursing
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lenette M Jones, PhD
Email
lenettew@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Building a Multidisciplinary Research Program to Address Hypertension Disparities: Exploring the Neurocognitive Mechanisms of a Self-Management Intervention for African American Women
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