ENACTS Intervention for High Blood Pressure

(ENACTS Trial)

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

270 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

Our Specific Aims are: 1. At the individual level, to compare within-person change in BP and secondary outcomes between the intervention and control groups. 2. At the family level, to evaluate ENACTS' effects on BP and secondary outcomes as within-person change in family members who provide primary support, and as mean change in other adult family members who are not directly engaged in the intervention. 3. At the policy level, to evaluate the intervention's ability to influence grocery store policy on clearly identifying foods that are low in sodium or high in potassium, some of which might not be easily identified with existing labels (e.g., fresh produce). ENACTS combines empirically supported elements of existing programs, thus increasing its probability of success. It aligns with the American Heart Association's call for multilevel prevention.

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.

Is the ENACTS Intervention for High Blood Pressure safe for humans?

The safety of blood pressure treatments, including those similar to ENACTS, has been studied, but there are concerns about side effects like impacts on lipids (fats in the blood), potassium, and glucose tolerance. It's important to choose treatments carefully to avoid these issues and ensure they don't negatively affect quality of life. ^{1 2 3 4 5}

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]

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]

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]

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]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Issues with antihypertensive therapy: safety perspectives. [2019]

2. Netherlands 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. [2018]

3. England pubmed.ncbi.nlm.nih.gov

The reporting of harms in randomized controlled trials of hypertension using the CONSORT criteria for harm reporting. [2016]

4. United States pubmed.ncbi.nlm.nih.gov

Trends in blood pressure diagnosis, treatment, and control among VA nursing home residents, 2007-2018. [2023]

5. Netherlands pubmed.ncbi.nlm.nih.gov

1-Year outcomes of hypertension management in 13,000 outpatients under practice conditions: prospective 3A registry. [2014]