Health Information Intervention for High Blood Pressure

Overseen By Lenette M Jones, PhD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University of Michigan

Disqualifiers: Renal insufficiency, MOCA < 22, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how sharing health information can help African American women manage high blood pressure more effectively. It aims to determine if this approach improves self-management, controls blood pressure, and positively impacts brain activity related to emotions and self-awareness. The study includes one group receiving health education and another group focusing on information sharing (the Sharing Intervention) and brain activity. Women diagnosed with high blood pressure and who are right-handed may be suitable for this trial. As an unphased trial, it offers participants the chance to contribute to innovative research that could enhance health management strategies.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this research protocol is safe?

Research has shown that interventions like the one in this trial are generally safe and well-tolerated. For instance, studies involving community health workers found that these methods can effectively lower blood pressure without major safety issues.

Digital health tools designed to manage high blood pressure have also improved blood pressure levels, particularly in groups experiencing health inequalities. This indicates that these tools are both effective and safe for a wide range of people.

Overall, while specific side effect data for this trial's intervention is not yet available, similar strategies used in other studies support their safety in managing high blood pressure. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a unique way to manage high blood pressure by promoting information sharing and stimulating broad cortical neural networks, specifically the default mode network (DMN). Unlike standard treatments that focus primarily on lifestyle changes like the DASH diet, exercise, or medication adherence, this approach emphasizes emotion-management and self-awareness. By targeting the DMN, researchers hope to offer a more holistic way to control blood pressure, which could lead to improved patient outcomes and better long-term management of the condition.

What evidence suggests that this intervention is effective for high blood pressure?

Research has shown that team-based care can greatly improve blood pressure control. One study found that these programs lowered the average systolic blood pressure by about 7 points. Another study showed that 57% of patients in similar programs managed to control their blood pressure within a year. In this trial, participants in the intervention arm will receive a comprehensive approach that includes education on a low sodium diet, exercise, and medication adherence, along with promoting information sharing and stimulating broad cortical neural networks. This approach could be especially beneficial for African American women with high blood pressure, as it emphasizes self-care and education. Team-based care is also cost-effective and can help manage high blood pressure, which is often preventable. ^{2 5 6 7 8}

Are You a Good Fit for This Trial?

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 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.

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

I have had kidney problems in the past.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive education on a low sodium diet, exercise, and medication adherence, with an emphasis on information sharing and stimulating neural networks.

6 months

Follow-up

Participants are monitored for changes in brain activity, blood pressure, and quality of life.

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Sharing 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.

How Is the Trial Designed?

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+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11284891/

Effectiveness of team-based care interventions in improving ... We evaluated the effectiveness of team-based care interventions in improving blood pressure (BP) outcomes among adults with hypertension in Africa.

2. cdc.gov cdc.gov/high-blood-pressure/php/data-research/team-based-care/index.html

Team-Based Care to Improve Blood Pressure Control The CPSTF found that team-based care is a cost-effective intervention to improve blood pressure control.1 Uncontrolled high blood pressure is a preventable ...

3. bmcpublichealth.biomedcentral.com bmcpublichealth.biomedcentral.com/articles/10.1186/s12889-025-24283-x

Assessing Community-Based interventions effectiveness on ... Meta-analysis results of 34 studies showed that the interventions reduced the mean systolic blood pressure by 7.26 mmHg [5.32–9.2, CI = 95%] and ...

4. publichealth.jhu.edu publichealth.jhu.edu/center-for-health-equity/2024/tailored-interventions-lower-blood-pressure-for-groups-experiencing-health-disparities

Tailored Interventions Lower Blood Pressure for Groups ... Fifty-seven percent of patients in both programs achieved blood pressure control at one year. The two programs reduced systolic blood pressure ( ...

5. ahajournals.org ahajournals.org/doi/10.1161/CIRCULATIONAHA.124.069622

Equitable Care for Hypertension: Blood Pressure and ... Table 4 shows the primary outcome percentage of BP control at 12 months by intervention arm for all patients and separately for Black, White, ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11556888/

Task-sharing with community health workers to treat ... which showed that sharing tasks with governmental CHWs in Bangladesh, Pakistan, and Sri Lanka can reduce systolic blood pressure (BP) by an average of 5.2 mm Hg ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10867699/

Digital Health Interventions for Hypertension Management in ... These findings suggest that digital health interventions are associated with improved BP levels in populations experiencing health disparities.

8. ahajournals.org ahajournals.org/doi/10.1161/HYP.0000000000000232

Implementation Strategies to Improve Blood Pressure ... This scientific statement provides information on the implementation strategies to optimize hypertension management and to improve BP control among adults in ...