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Rationale, design and baseline results of the Treatment Optimisation in Primary care of Heart failure in the Utrecht region (TOPHU) study: a cluster randomised controlled trial.

ABSTRACT: Heart failure (HF) is mainly detected and managed in primary care, but the care is considered suboptimal. We present the rationale, design and baseline results of the Treatment Optimisation in Primary care of Heart failure in the Utrecht region (TOPHU) study. In this study we assess the effect of a single training of GPs in the pharmacological management of patients with HF.A cluster randomised controlled trial. Thirty primary care practices are randomly assigned to care as usual or intervention defined as a single training in the up-titration and management of HF drug therapy according to the heart failure guidelines of the European Society of Cardiology (ESC). Patients with a GP's diagnosis of HF will be re-evaluated by an expert panel of two cardiologists and a GP with expertise in HF to come to a definite diagnosis of HF according to the ESC heart failure guidelines. Those with definite HF will be analysed in this study. Drug use will be measured after six months, health status after twelve months, and heart-related hospital admissions and all-cause mortality after two years.Our cluster randomised trial will show whether a single training of GPs improves the pharmacological management of patients with HF and confers beneficial effects on health status after one year, and cardiac hospital admissions and all-cause mortality after two years of follow-up.ClinicalTrials.gov Identifier NCT01662323.

SUBMITTER: Valk MJ

PROVIDER: S-EPMC4596366 | biostudies-literature | 2015 Oct

REPOSITORIES: biostudies-literature

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Rationale, design and baseline results of the Treatment Optimisation in Primary care of Heart failure in the Utrecht region (TOPHU) study: a cluster randomised controlled trial.

Valk Mark J MJ Hoes Arno W AW Mosterd Arend A Landman Marcel A MA Broekhuizen Berna D L BD Rutten Frans H FH

BMC family practice 20151007

<h4>Background</h4>Heart failure (HF) is mainly detected and managed in primary care, but the care is considered suboptimal. We present the rationale, design and baseline results of the Treatment Optimisation in Primary care of Heart failure in the Utrecht region (TOPHU) study. In this study we assess the effect of a single training of GPs in the pharmacological management of patients with HF.<h4>Methods/design</h4>A cluster randomised controlled trial. Thirty primary care practices are randomly ...[more]

PMID: 26446696

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Project description:BackgroundExposure to unhealthy environments and inadequate child stimulation are main risk factors that affect children's health and wellbeing in low- and middle-income countries. Interventions that simultaneously address several risk factors at the household level have great potential to reduce these negative effects. We present the design and baseline findings of a cluster-randomised controlled trial to evaluate the impact of an integrated home-environmental intervention package and an early child development programme to improve diarrhoea, acute respiratory infections and childhood developmental outcomes in children under 36 months of age living in resource-limited rural Andean Peru.MethodsWe collected baseline data on children's developmental performance, health status and demography as well as microbial contamination in drinking water. In a sub-sample of households, we measured indoor kitchen 24-h air concentration levels of carbon monoxide (CO) and fine particulate matter (PM2.5) and CO for personal exposure.ResultsWe recruited and randomised 317 children from 40 community-clusters to four study arms. At baseline, all arms had similar health and demographic characteristics, and the developmental status of children was comparable between arms. The analysis revealed that more than 25% of mothers completed primary education, a large proportion of children were stunted and diarrhoea prevalence was above 18%. Fifty-two percent of drinking water samples tested positive for thermo-tolerant coliforms and the occurrence of E.coli was evenly distributed between arms. The mean levels of kitchen PM2.5 and CO concentrations were 213 μg/m3 and 4.8 ppm, respectively.ConclusionsThe trial arms are balanced with respect to most baseline characteristics, such as household air and water pollution, and child development. These results ensure the possible estimation of the trial effectiveness. This trial will yield valuable information for assessing synergic, rational and cost-effective benefits of the combination of home-based interventions.Trial registryISRCTN-26548981.

Dataset Information

Rationale, design and baseline results of the Treatment Optimisation in Primary care of Heart failure in the Utrecht region (TOPHU) study: a cluster randomised controlled trial.

Publications

Rationale, design and baseline results of the Treatment Optimisation in Primary care of Heart failure in the Utrecht region (TOPHU) study: a cluster randomised controlled trial.

Similar Datasets

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