ENACTS Intervention for High Blood Pressure

(ENACTS Trial)

No longer recruiting at 1 trial location

Overseen By Odile Madesclaire

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Washington State University

Must be taking: Antihypertensives, Diabetes medications

Disqualifiers: Pregnancy, Dialysis, Terminal illness, others

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

Compensation: Varies

Number of Visits: 8

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the effectiveness of a program called ENACTS in helping people manage high blood pressure (hypertension). Participants will either receive usual care or attend four educational classes focused on managing their condition. The study also examines how this program might assist family members and encourage grocery stores to better label heart-healthy foods. It suits adults with high blood pressure or type 2 diabetes who have a prescription for related medication and reliable internet access. As an unphased trial, this study provides a unique opportunity to contribute to innovative strategies for managing hypertension and enhancing community health.

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 is best to consult with the trial coordinators for specific guidance.

What prior data suggests that the ENACTS intervention is safe for managing high blood pressure?

Research has shown that the ENACTS program, which includes educational classes, is designed to help manage high blood pressure. No direct evidence of side effects suggests it is likely well-tolerated. The program does not use medication or involve medical procedures, typically resulting in a lower risk of side effects. Instead, it focuses on teaching skills to manage high blood pressure independently. Programs like this generally pose fewer risks compared to medication.

Due to the absence of specific data on side effects, ENACTS is in a "Not Applicable" phase. This indicates it is not a new drug or device and usually lacks significant side effects. However, healthcare professionals will monitor participants to ensure safety, as with any new health program. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the ENACTS intervention for high blood pressure because it focuses on empowering patients through education rather than relying solely on medication. Unlike standard treatments that often involve drugs such as ACE inhibitors or beta-blockers, ENACTS offers four peer-facilitated educational classes over eight weeks, teaching participants how to manage hypertension themselves. This approach is unique as it emphasizes self-management and community support, potentially leading to long-term lifestyle changes and improved health outcomes.

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

Research has shown that effectively treating high blood pressure can reduce the risk of serious health problems like stroke and heart failure. In this trial, participants in the Intervention Group will receive the ENACTS intervention, which includes four peer-facilitated educational classes over 8 weeks focused on hypertension self-management. Studies have found that involving community health workers can help lower blood pressure in patients. Programs like ENACTS offer educational classes to help people manage their blood pressure better. Reviews of multiple studies suggest that digital health tools can improve blood pressure control. These findings support the idea that focusing on education and community support can successfully manage high blood pressure. ^{1 6 7 8 9}

Who Is on the Research Team?

denise dillard

Principal Investigator

Washington State University

Are You a Good Fit for This Trial?

The ENACTS trial is for Native Hawaiian/Pacific Islander adults with high blood pressure or type 2 diabetes. Participants must have internet access, speak English, and be willing to follow the study's rules. They can't join if they're pregnant, planning pregnancy, on dialysis, or receiving treatment for a terminal illness.

Inclusion Criteria

It seems like you've provided a phrase without the context of a clinical trial exclusion criterion. Could you please provide more details or rephrase the criterion?

I have been diagnosed with hypertension or type 2 diabetes and take medication for it.

Self-reported NHPI race

Exclusion Criteria

I am on dialysis or receiving treatment for a terminal illness.

Pregnant or planning on becoming pregnant throughout the course of the study

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive the ENACTS intervention, which includes peer-facilitated educational classes on hypertension self-management delivered weekly for 8 weeks.

8 weeks

8 visits (in-person)

Follow-up

Participants are monitored for changes in blood pressure and secondary outcomes such as food purchasing behaviors, medication adherence, and social support.

6 months

What Are the Treatments Tested in This Trial?

Interventions

• ENACTS

Trial Overview ENACTS aims to lower blood pressure (BP) in individuals and their family supporters by promoting low-sodium/high-potassium diets through policy changes at grocery stores. It tests these interventions' effectiveness at individual, family, and policy levels.

How Is the Trial Designed?

Group I: Intervention Group Experimental Treatment 1 Intervention

The ENACTS intervention is four peer-facilitated educational classes delivered over 8 weeks focused on hypertension self-management.

Group II: Waitlist Group Active Control 1 Intervention

Usual care and $50 in groceries every other week for 8 weeks.

Who Is Running the Clinical Trial?

Washington State University

Lead Sponsor

Trials

114

Recruited

58,800+

Published Research Related to This Trial

Long-term studies have shown that treating hypertension significantly reduces the risk of serious health issues like stroke and heart failure, highlighting the importance of effective blood pressure management.

When selecting antihypertensive medications, it's crucial to consider their safety profiles and side effects; alternatives like ACE inhibitors and calcium channel blockers may be better initial choices for some patients compared to thiazide diuretics and beta-blockers, which can have adverse metabolic effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Issues with antihypertensive therapy: safety perspectives. Jackson, EA.[2019]

In a review of 70 randomized controlled trials involving nearly 256,000 participants, blood pressure-lowering treatments significantly reduced the risk of major cardiovascular events by 24%, but also led to an 89% increase in treatment discontinuations due to adverse events.

The analysis revealed that while greater reductions in blood pressure (BP) were associated with more significant cardiovascular benefits, they also resulted in a disproportionately higher number of patients discontinuing treatment, especially when systolic blood pressure (SBP) was lowered below 130 mmHg.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of blood pressure lowering treatment in hypertension: 8. Outcome reductions vs. discontinuations because of adverse drug events - meta-analyses of randomized trials. Thomopoulos, C., Parati, G., Zanchetti, A.[2018]

In a study of 13,433 patients with high blood pressure over one year, no significant differences in blood pressure reduction were found between those treated with aliskiren, ACE inhibitors/angiotensin receptor blockers, or non-renin angiotensin system agents, indicating similar efficacy across these treatments.

Despite the higher number of antihypertensive medications used in the aliskiren group, the overall rate of major cardiac events was low (1.3%) and consistent across all treatment groups, suggesting that aggressive blood pressure management can lead to positive outcomes in high-risk patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

1-Year outcomes of hypertension management in 13,000 outpatients under practice conditions: prospective 3A registry. Zeymer, U., Dechend, R., Riemer, T., et al.[2014]

The prevalence of hypertension diagnosis among nursing home residents increased significantly from 75.2% to 85.1% over a decade, indicating a growing recognition of high blood pressure in this population.

Despite high treatment rates (80.3% treated) and good control of blood pressure (80.1% with average BP <140/90 mmHg), certain high-risk groups, such as Black and Hispanic residents and those with diabetes or renal disease, still had elevated blood pressure levels, highlighting the need for targeted interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Trends in blood pressure diagnosis, treatment, and control among VA nursing home residents, 2007-2018. Odden, MC., Li, Y., Graham, LA., et al.[2023]

A review of 41 hypertension clinical trials revealed that, on average, less than half of the recommended items for reporting harms were reported, with a mean of only 9.83 out of the total items suggested by the CONSORT extension.

This lack of comprehensive reporting on harms indicates a need for trialists to improve their measurement and analysis of adverse effects, ensuring that the evidence from these trials is more balanced and reliable.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The reporting of harms in randomized controlled trials of hypertension using the CONSORT criteria for harm reporting. Bagul, NB., Kirkham, JJ.[2016]

Citations

1. withpower.com withpower.com/trial/phase-hypertension-5-2018-3894a

ENACTS Intervention for High Blood Pressure Long-term studies have shown that treating hypertension significantly reduces the risk of serious health issues like stroke and heart failure, highlighting the ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10339372/

Effectiveness of mHealth interventions for improving ... This meta‐analysis found that mHealth could significantly improve the uncontrolled hypertension control rate and might be a feasible, acceptable, and effective ...

3. ahajournals.org ahajournals.org/doi/10.1161/HYPERTENSIONAHA.120.15946

Health Care Delivery Interventions for Hypertension ... Five studies demonstrated the effectiveness of integrating community health workers into care workflows leading to reduction in BP and high ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT03483662

Implementation of Multifaceted Patient-Centered Treatment ... This study will generate urgently needed data on effective and adoptable intervention strategies aimed at eliminating health disparities and reducing the BP- ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10302854/

Effectiveness evaluation of a hypertension management ... Results showed that 53.4% of patients had controlled hypertension pre-intervention (September 2016-September 2018); 57.3% had controlled hypertension at the end ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05937685

NCT05937685 | Reducing Blood Pressure in Patients With ... The goal of this clinical trial is to test if this team based program is better at helping people reduce their blood pressure than usual care for people with ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8034801/

Guideline-Driven Management of Hypertension: An Evidence ... In adults with hypertension, control of BP with antihypertensive medication reduces the risk of CVD and all-cause mortality. Thus, hypertension is one of the ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT03541174

NCT03541174 | A Research Study to Show the Effect of ... The goal of this clinical trial is to show the blood pressure lowering effect of aprocitentan, a new drug, when added to other anti-hypertensive drugs.

9. ahajournals.org ahajournals.org/doi/10.1161/JAHA.121.024975

BP MAP A Pragmatic Cluster Randomized Trial In this randomized trial, 2 methods of implementing a quality improvement intervention in 24 safety net clinics led to modest improvements in BP control.