HypertensionNCT04266704

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

A study testing Sharing Intervention in people with Hypertension, run by University of Michigan at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 65 years, women onlyHealthy volunteers can take part
Conditions the study is for: Hypertension
What is being tested?: Sharing Intervention
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 50 participants
Where: 1 siteUnited States
Study dates: 13 Jun 2023to 25 Apr 2025
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
Women only
Healthy volunteers accepted
Adult, Older adult

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Michigan School of Nursing
Ann Arbor, Michigan, 48109

Other trials in United States

About this study

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.

Conditions: Hypertension
Being tested: Sharing Intervention
Medical subject headings: Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Sharing InterventionBehavioural
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).

Study groups in NCT04266704
Study group	Role	What they receive
Intervention	Experimental	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. Receives: Behavioral: Sharing Intervention
Control	Active comparator	education on a low sodium diet (Dietary Approaches to Stop Hypertension or DASH), exercise, and medication adherence Receives: Behavioral: Sharing Intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

Brain Activity
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.
Measured: 6 months

Secondary outcomes (4)

Systolic Blood Pressure
Blood pressure was measured using automated sphygmomanometer based on standardized protocols.
Measured: 6 months
Diastolic Blood Pressure
Blood pressure was measured using automated sphygmomanometer based on standardized protocols.
Measured: 6 months
PROMIS - Mental Health
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.
Measured: 6 months
PROMIS - Physical Health
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.
Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

13 Jun 202325 Apr 2025

First posted12 Feb 2020
Study start13 Jun 2023
Primary completion25 Apr 2025
Study completion25 Apr 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for HypertensionStudies of the same condition, open and under way.
More trials run by University of MichiganThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 50 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04266704
Sponsor's protocol ID: HUM00226482
Other IDs: 1K01HL145366-01
Status last verified: Apr 2026
First submitted: 10 Feb 2020
Last updated: 1 Sep 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Hypertension trials

Study at a glance

From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Building a Multidisciplinary Research Program to Address Hypertension Disparities: Exploring the Neurocognitive Mechanisms of a Self-Management Intervention for African American Women
ClinicalTrials.gov ID: NCT04266704
Acronym / sponsor ID: HUM00226482
Conditions: Hypertension
Study type: Interventional
Recruitment status: Completed
Enrolment: 50 participants (actual)
Lead sponsor: University of MichiganUniversity, hospital or other
Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
Study start: 13 Jun 2023 (actual)
Primary completion: 25 Apr 2025 (actual)
Study completion: 25 Apr 2025 (actual)
First posted: 12 Feb 2020 (actual)
Results: Posted 1 Sep 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Intervention	Experimental	Behavioral: Sharing InterventionAlong 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.
Control	Active comparator	Behavioral: Sharing Interventioneducation on a low sodium diet (Dietary Approaches to Stop Hypertension or DASH), exercise, and medication adherence

Who may qualify

Ages: 18 to 65 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Sharing Interventionintervention 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).	Behavioural	Control, Intervention

Primary outcome

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.

4 secondary outcomes

Systolic Blood Pressure
Time frame: 6 months
Diastolic Blood Pressure
Time frame: 6 months
PROMIS - Mental Health
Time frame: 6 months
PROMIS - Physical Health
Time frame: 6 months

Results and safety

Results posted to the registry on 1 Sep 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Intervention	25	13
Control	25	19

Primary outcome: Brain Activity

Time frame: 6 months. Mean (Standard Deviation). Unit: Values reﬂect % change in BOLD response

Measure	Intervention n = 3	Control n = 2
Value	0.08 (0.38)	0.29 (0.26)

Population analysed: Due to the cost of conducting fMRI, the study was designed to evaluate brain activity in a subset of participants. At baseline, the recruitment target was met (n =10). However, due to participant drop out - the final number of fMRI scans available for analysis was n = 5.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: from enrollment until end of follow-up, up to 6 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Intervention	0 of 25 (0%)	0 of 25 (0%)	0 of 25
Control	0 of 25 (0%)	0 of 25 (0%)	0 of 25

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Hypertension

RecruitingObservational study
Natural History Study of Biomarkers in Pulmonary Arterial Hypertension
Pulmonary Disease, Pulmonary Hypertension
RecruitingObservational study
Natural History of Noncirrhotic Portal Hypertension
Cystic Fibrosis, Immunologic Deficiency Syndrome
RecruitingPhase 2
Lu-177-DOTATATE (Lutathera) in Therapy of Inoperable Pheochromocytoma/ Paraganglioma
Pheochromocytoma, Paraganglioma
RecruitingObservational study
Clinical and Molecular Characteristics of Primary Aldosteronism in Blacks
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RecruitingObservational study
Prevalence, Phenotypes, Predictors and Prognostic Implication of Obstructive Sleep Apnea in Pulmonary Hypertension
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Sharing Intervention in people with Hypertension, run by University of Michigan at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 Sep 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Brain Activity (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04266704.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2026; AzTrials last refreshed its copy on 26 Oct 2026.