What question did this study set out to answer?

To evaluate whether a combined intervention of medication self-titration, home blood pressure monitoring, and lifestyle changes reduces systolic blood pressure in patients with uncontrolled hypertension.

April 1, 2020MedicineOpen Access

Effectiveness of a multifactorial intervention, consisting of self-management of antihypertensive medication, self-measurement of blood pressure, hypocaloric and low sodium diet, and physical exercise, in patients with uncontrolled hypertension taking 2 or more antihypertensive drugs

Q: What is the clinical evidence from this study?

Study design: RCT. Population: Uncontrolled hypertension (n=424). Intervention: Multifactorial intervention (self-management of medication, self-measurement of BP, DASH diet, physical exercise) vs. Regular clinical practice. Primary outcome: Systolic blood pressure at 12 months.

View Full Paper

Ask AI

Bookmark

Key result

This is a study protocol for a cluster-randomized trial evaluating a multifactorial intervention for uncontrolled hypertension; no results are available yet.

Why the study?

Fewer than half of patients receiving pharmacological treatment for hypertension achieve adequate blood pressure control, largely due to therapeutic inertia, poor treatment adherence, and unhealthy lifestyles.

Does a multifactorial intervention (self-management, diet, exercise) reduce systolic blood pressure at 12 months in patients with uncontrolled hypertension taking 2 or more antihypertensive drugs?

Population

424 primary care patients taking 2 or more antihypertensive drugs with blood pressure of at least 130/80 on 24-h ABPM

Comparison

Multifactorial intervention vs regular clinical practice

Design

Multicentre parallel 2-arm single-blind (outcome assessor) cluster-randomized clinical trial

Follow-up

12 months

Authors

FVFabián Unda VillafuerteGovern de les Illes Balears JCJoan Llobera CànavesHealth Research Institute of the Balearic Islands PLPatricia LorenteEstación Experimental de Aula Dei

Discussion

Member takes

Implication

This trial protocol outlines a cluster-randomized study to evaluate whether a multifactorial lifestyle and self-management intervention improves blood pressure control in patients with uncontrolled hypertension on multiple medications.

Key Points

To evaluate whether a combined intervention of medication self-titration, home blood pressure monitoring, and lifestyle changes reduces systolic blood pressure in patients with uncontrolled hypertension.
Multicenter, parallel, two-arm, single-blind, cluster-randomized clinical trial conducted across primary care centers.
Recruited 424 patients receiving two or more antihypertensive medications with 24-hour ambulatory blood pressure measurements of at least 130/80 mm Hg.
Intervention arm receives training in medication self-management, self-measurement of blood pressure, a hypocaloric and low-sodium diet, and exercise, compared to usual care over 12 months.
Primary endpoint data are pending completion of the trial; the primary outcome measure is change in systolic blood pressure at 12 months.
Secondary endpoints being tracked include blood pressure control below 140/90 mm Hg, medication adherence, EuroQol 5D quality of life, healthcare costs, and cardiovascular risk scores.

Study Design

Type

RCT (n=424)

Blinding

Single-blind

Randomization

Cluster-randomized

Multicenter

Yes

Structured PICO

Does a multifactorial intervention (self-management, diet, exercise) reduce systolic blood pressure at 12 months in patients with uncontrolled hypertension taking 2 or more antihypertensive drugs?

Population

A planned cluster-randomized trial of 424 patients aged 35-75 with uncontrolled hypertension on 2 or more antihypertensive drugs, followed for 12 months.

Intervention

Multifactorial intervention consisting of self-management of antihypertensive medication, self-measurement of blood pressure, hypocaloric and low sodium diet, and physical exercise

Comparator

Regular clinical practice

Outcome

Systolic blood pressure at 12 monthssurrogate

Cite This Study

Villafuerte et al. (2020) conducted an RCT in Uncontrolled hypertension (n=424). Multifactorial intervention (self-management of medication, self-measurement of BP, DASH diet, physical exercise) vs. Regular clinical practice was evaluated on Systolic blood pressure at 12 months. This is a study protocol for a cluster-randomized trial evaluating a multifactorial intervention for uncontrolled hypertension; no results are available yet.

synapsesocial.com/papers/6a9d86ef34685bd7702a096a https://doi.org/10.1097/md.0000000000019769

Topics

Hypertension management

View Full Paper

Ask AI

Bookmark

Effectiveness of a multifactorial intervention, consisting of self-management of antihypertensive medication, self-measurement of blood pressure, hypocaloric and low sodium diet, and physical exercise, in patients with uncontrolled hypertension taking 2 or more antihypertensive drugs

Discussion

Member takes

Implication

Key Points

Study Design

Structured PICO

Cite This Study

Topics

Effectiveness of a multifactorial intervention, consisting of self-management of antihypertensive medication, self-measurement of blood pressure, hypocaloric and low sodium diet, and physical exercise, in patients with uncontrolled hypertension taking 2 or more antihypertensive drugs

Discussion

Member takes

Implication

Key Points

Study Design

Structured PICO

Cite This Study

Also Consider

Topics

Also Consider