ENACTS Intervention for High Blood Pressure (ENACTS Trial)
Recruiting in Palo Alto (17 mi)
+1 other location
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Washington State University
No Placebo Group
Trial Summary
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.
Do I have to stop taking my current medications for the trial?The protocol does not specify if you need to stop taking your current medications. However, since the trial involves participants with hypertension or type 2 diabetes who are already on medication, it seems likely that you can continue your current medications.
Is the ENACTS treatment a promising way to lower high blood pressure?Yes, the ENACTS treatment is promising because it helps improve blood pressure control, as seen in similar interventions that use education and lifestyle changes to manage hypertension effectively.38111314
What safety data is available for the ENACTS treatment for high blood pressure?The provided research does not specifically mention the ENACTS treatment for high blood pressure or its safety data. However, it highlights general safety considerations for antihypertensive therapies, such as the need to choose drugs based on their hemodynamic profile and absence of adverse effects. It also notes that adverse events in blood pressure-lowering treatments have not been systematically surveyed, and that the reporting of harms in hypertension trials is often incomplete. This suggests a need for more comprehensive safety data specific to ENACTS.1791012
What data supports the idea that ENACTS Intervention for High Blood Pressure is an effective treatment?The available research does not provide specific data on the effectiveness of the ENACTS Intervention for High Blood Pressure. Instead, it highlights general challenges in implementing hypertension treatment guidelines and the need for better adherence to these guidelines. For example, one study found that a majority of patients did not achieve blood pressure control, indicating room for improvement in treatment strategies. Another study emphasized the importance of educating patients and healthcare providers to improve outcomes. However, there is no direct comparison or specific data on ENACTS itself.245614
Eligibility Criteria
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
I have been diagnosed with hypertension or type 2 diabetes and take medication for it.
I am 18 years old or older.
I have been diagnosed with hypertension or type 2 diabetes and take medication for it.
Exclusion Criteria
I am on dialysis or receiving treatment for a terminal illness.
Participant Groups
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.
2Treatment groups
Experimental Treatment
Active Control
Group I: Intervention GroupExperimental Treatment1 Intervention
The ENACTS intervention is four peer-facilitated educational classes delivered over 8 weeks focused on hypertension self-management.
Group II: Waitlist GroupActive Control1 Intervention
Usual care and $50 in groceries every other week for 8 weeks.
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
National Recruitment via Facebook and InternetSeattle, WA
Asian Counseling and Referral ServiceSeattle, WA
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Who is running the clinical trial?
Washington State UniversityLead Sponsor
References
Issues with antihypertensive therapy: safety perspectives. [2019]The benefits of treating hypertension have been documented by several long-term studies that have shown a decreased incidence of morbidity and mortality associated with stroke, left ventricular failure, and renal insufficiency. With the large number of antihypertensive drugs currently available, several safety factors need to be considered when initially choosing a regimen so as not to adversely influence the potential benefits of blood pressure control. Antihypertensive agents should be chosen based on their hemodynamic profile, the absence of adverse metabolic effects and subjective side effects, and the presence of beneficial effects on the patients' quality of life. Thiazide diuretics and beta-blocking agents have often been recommended as initial therapy in patients with mild to moderate hypertension. However, thiazide diuretics may be less desirable in certain patients because of their effects on lipids, potassium, and glucose tolerance; beta-blocking agents are not ideal for some patients because of their effects on lipids, exercise tolerance, and overall quality of life. The angiotensin-converting enzyme inhibitors, selective alpha 1-blocking agents, and calcium channel blocking agents may be more appropriate for initial therapy of hypertension in many patients.
Opportunities for improving the quality of hypertension care in a managed care setting. [2019]Hypertension management practices and patient health outcomes in a managed care setting were evaluated. Health-system pharmacists analyzed plan medical and pharmacy claims data for September 1, 1998, to August 31, 1999, to identify hypertensive enrollees (n = 23,316). Reviews of pharmacy claims and medical charts of a sample of hypertensive patients (n = 374) determined blood pressure control status, prevalence of cardiovascular risk factors, and comorbidities. The majority of patients treated for hypertension (66%) did not achieve blood pressure control. Analysis revealed a high prevalence of cardiovascular risk factors among hypertensive patients, with 92.2% of study patients having two or more risk factors. Reviews of 132,512 pharmacy claims revealed that one half of all prescribed therapies were for monotherapy, and 21% of hypertensive patients were prescribed combination therapy with two different agents. Data from a large managed care organization revealed that more than half of all hypertensive patients had inadequate blood pressure control. A quality improvement program for hypertension care that can improve patient health outcomes must educate patients and health care providers about the implications of the disease, identify patients with compelling comorbidities, evaluate pharmacologic regimens, and recommend therapeutic changes when necessary.
Control of cardiovascular risk factors in patients with diabetes and hypertension at urban academic medical centers. [2022]There are national mandates to reduce blood pressure (BP) to
Hypertension treatment in a medicare population: adherence and systolic blood pressure control. [2018]Despite substantial trial evidence that demonstrates the effectiveness of pharmacologic treatment for reducing blood pressure (BP) and cardiovascular events, many patients are nonadherent to their hypertension treatment.
A multifaceted intervention to improve blood pressure control: The Guideline Adherence for Heart Health (GLAD) study. [2021]Although high blood pressure is associated with significant morbidity and mortality, the proportion reaching the goal blood pressures as outlined in the Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, Treatment of High Blood Pressure (JNC 7) is low. We conducted a randomized trial in primary care practices of a multifactorial intervention targeted to improve providers' adherence to hypertension guidelines.
Translation of hypertension treatment guidelines into practice: a review of implementation. [2019]Compared with the history of national guideline development, the science attached to implementation of guidelines is relatively new. Effectiveness of a highly evidence-based guideline, such as the 8th Joint National Committee recommendations on the treatment of high blood pressure, depends on successful translation into clinical practice. Implementation relies on several steps: clear and executable guideline language, audit and feedback attached to education of practitioners charged with carrying out the guidelines, team-based care delivery, credibility of blood pressure measurement, and measures to address therapeutic inertia and medication adherence. An evolving role of the electronic health record and patient empowerment are developments that will further promote implementation of the hypertension guideline. Further research will be needed to assess the efficacy and cost effectiveness of various implementation tools and strategies.
The reporting of harms in randomized controlled trials of hypertension using the CONSORT criteria for harm reporting. [2016]The aim of this study was to assess the quality of reporting of harms in hypertension clinical trials identified from the Cochrane Database using the Consolidated Standards of Reporting Trials (CONSORT) extension for harms reporting. Forty-one hypertension trials were included in the study. On average trials reported less than half of the items recommended by the CONSORT extension for harms (mean 9.83 items; 95% confidence interval = 8.06, 11.60). Trialists need to address the perceived shortcomings in measurement, analysis, and reporting of harms data so that the available trial data can be considered as a balanced and reliable source of evidence.
The physician's role in prescribing physical activity for the prevention and treatment of essential hypertension. [2021]Blood pressure control and prevention of hypertension can be achieved by both pharmacological and lifestyle interventions; one important lifestyle intervention is physical activity. Participation in regular physical activity can modestly lower blood pressure by reducing total peripheral resistance; it can also reduce the risk of developing hypertension and improve morbidity and mortality outcomes. Therefore, physical activity is a recommended intervention for the majority of hypertensive or prehypertensive patients. The precise level of physical activity required to lower blood pressure is unknown; however, in the UK, national minimum physical activity guidelines would seem appropriate for most hypertensives. Current patient physical activity levels can be assessed easily using retrospective recall questionnaires; preparticipation screening and exercise modifications for high-risk patients may reduce the risk of adverse events during subsequent exercise; and identification of a patient's willingness to increase physical activity levels may help to tailor physical activity advice. Health professional counselling or advice on physical activity is currently the most effective researched intervention. Its success can be maximized by delivering physical activity advice and counselling multiple times using different health professionals in person or over the telephone and by offering additional written materials. While the most effective methods for increasing physical activity levels in patients are probably still unclear, physical activity is an advisable intervention for the majority of hypertensive patients.
1-Year outcomes of hypertension management in 13,000 outpatients under practice conditions: prospective 3A registry. [2014]Current data on characteristics and outcomes of patients with high blood pressure (BP) managed under clinical practice conditions are limited.
Effects of blood pressure lowering treatment in hypertension: 8. Outcome reductions vs. discontinuations because of adverse drug events - meta-analyses of randomized trials. [2018]Previous meta-analyses of randomized controlled trials (RCTs) of blood pressure (BP)-lowering treatment provided overwhelming evidence that treatment markedly reduces risk of cardiovascular outcomes in hypertensive patients. However, adverse events associated with BP-lowering treatment have never been surveyed systematically.
Effectiveness of a School-Based Educational Intervention to Improve Hypertension Control Among Schoolteachers: A Cluster-Randomized Controlled Trial. [2022]Background The control of hypertension is low in low- and middle-income countries like India. We evaluated the effects of a nurse-facilitated educational intervention in improving the control rate of hypertension among school teachers in India. Methods and Results This was a cluster-randomized controlled trial involving 92 schools in Kerala, which were randomly assigned equally into a usual care group and an intervention group. Participants were 402 school teachers (mean age, 47 years; men, 29%) identified with hypertension. Participants in both study groups received a leaflet containing details of a healthy lifestyle and the importance of regular intake of antihypertensive medication. In addition, the intervention participants received a nurse-facilitated educational intervention on hypertension control for 3 months. The primary outcome was hypertension control. Key secondary outcomes included systolic blood pressure, diastolic blood pressure, and the proportion of participants taking antihypertensive medications. For the primary outcome, we used mixed-effects logistic regression models. Two months after a 3-month educational intervention, a greater proportion of intervention participants (49.0%) achieved hypertension control than the usual care participants (38.2%), with an odds ratio of 1.89 (95% CI, 1.06-3.35), after adjusting for baseline hypertension control. The odds of taking antihypertensive medications were 1.6 times higher in the intervention group compared with the usual care group (odds ratio, 1.62; 95% CI, 1.08-2.45). The reduction in mean systolic blood pressure was significantly greater in the intervention group by 4.2 mm Hg (95% CI, -7.2 to -1.1) than in the usual care group. Conclusions A nurse-facilitated educational intervention was effective in improving the control and treatment rates of hypertension as well as reducing systolic blood pressure among schoolteachers with hypertension. Registration URL: https://www.ctri.nic.in; Unique Identifier: CTRI/2018/01/011402.
Trends in blood pressure diagnosis, treatment, and control among VA nursing home residents, 2007-2018. [2023]Inadequate treatment of high blood pressure (BP) can lead to preventable adverse events in nursing home residents, while excessive treatment can lead to associated harms.
Implementing a home-based virtual hypertension programme-a pilot feasibility study. [2023]Implementing a health system-based hypertension programme may lower blood pressure (BP).
What BP target is appropriate for pregnant patients with mild chronic hypertension? [2023]Active treatment to a lower blood pressure goal (