Trials
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Randomized Controlled Trial Multicenter Study
Evaluation of a tailored intervention to improve management of overweight and obesity in primary care: study protocol of a cluster randomised controlled trial.
In the UK around 22% of men and 24% of women are obese, and there are varying but worrying levels in other European countries. Obesity is a chronic condition that carries an important health risk. National guidelines, for use in England, on the management of people who are overweight or obese have been published by the National Institute for Health and Clinical Excellence (NICE, 2006). NICE recommendations for primary care teams are: determine the degree of overweight and obesity; assess lifestyle, comorbidities and willingness to change; offer multicomponent management of overweight and obesity; referral to external services when appropriate. This study investigates a tailored intervention to improve the implementation of these recommendations by primary care teams. ⋯ Although often recommended, the methods of tailoring implementation interventions to account for the determinants of practice are not well developed. This study is part of a programme of studies seeking to develop the methods of tailored implementation.
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Randomized Controlled Trial Multicenter Study Comparative Study
The drooling reduction intervention trial (DRI): a single blind trial comparing the efficacy of glycopyrronium and hyoscine on drooling in children with neurodisability.
Drooling saliva is a common problem in children with neurodevelopmental disorders. The negative consequences of drooling include skin breakdown, dehydration, and damage to clothing and equipment. Children and families often suffer social embarrassment due to drooling. There is no evidence about the relative effectiveness, side effect profiles or patient acceptability of the two medications most commonly used to reduce drooling - glycopyrronium and hyoscine. Consequently, there is no consensus or guideline to aid clinical decisions about which drug to use, and at what dose. ⋯ Current Controlled Trials: ISRCTN75287237.EUDRACT: 2013-000863-94.Medicines and Healthcare products Regulatory Agency (MHRA): 17136/0264/001-0003.
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Randomized Controlled Trial Multicenter Study
HPTN 071 (PopART): rationale and design of a cluster-randomised trial of the population impact of an HIV combination prevention intervention including universal testing and treatment - a study protocol for a cluster randomised trial.
Effective interventions to reduce HIV incidence in sub-Saharan Africa are urgently needed. Mathematical modelling and the HIV Prevention Trials Network (HPTN) 052 trial results suggest that universal HIV testing combined with immediate antiretroviral treatment (ART) should substantially reduce incidence and may eliminate HIV as a public health problem. We describe the rationale and design of a trial to evaluate this hypothesis. ⋯ Trial results, combined with modelling and cost data, will provide short-term and long-term estimates of cost-effectiveness of UTT interventions. Importantly, the three-arm design will enable assessment of how much could be achieved by optimal delivery of current policies and the costs and benefits of extending this to UTT.
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Randomized Controlled Trial Multicenter Study Comparative Study
The By-Band study: gastric bypass or adjustable gastric band surgery to treat morbid obesity: study protocol for a multi-centre randomised controlled trial with an internal pilot phase.
The prevalence of severe and complex obesity is increasing worldwide and surgery may offer an effective and lasting treatment. Laparoscopic adjustable gastric band and Roux-en-Y gastric bypass surgery are the two main surgical procedures performed. ⋯ By-Band is the first pragmatic study to compare the two most commonly performed bariatric surgical procedures for severe and complex obesity. The design will enable and empower surgeons to learn to recruit and participate in a randomised study. Early evidence shows that timely recruitment is possible.
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Randomized Controlled Trial Multicenter Study
Pilot trial of Stop Delirium! (PiTStop)--a complex intervention to prevent delirium in care homes for older people: study protocol for a cluster randomised controlled trial.
Delirium (or acute confusion) is a serious illness common in older people, in which a person's thinking and perceptions may be affected. Reducing delirium is important because of the considerable distress it causes, and the poor outcomes associated with it, such as increased admissions to hospital, falls, mortality and costs to the National Health Service (NHS). Preventing delirium is possible using multicomponent interventions; successful interventions in hospitals have reduced it by one-third. However, there is little research to guide practice in care homes, where it is common because of the clustering of known risk factors (older age, frailty, and dementia). In previous work we developed a multicomponent intervention to prevent delirium in care homes, called Stop Delirium! The intervention was based upon evidence from the research literature relating to the prevention of delirium and on strategies to change professional practice. Before starting a large costly trial of Stop Delirium!, this pilot study will test and help improve the design and feasibility of the trial protocol. ⋯ This pilot study will refine methods for the definitive trial. The lessons learnt will also contribute to implementing National Institute for Health and Clinical Excellence (NICE) delirium guidelines, which recommend multicomponent interventions for delirium prevention.