Trials

http://www.trialsjournal.com/

List of Papers (Total 4,046)

STICKS study – Short-sTretch Inelastic Compression bandage in Knee Swelling following total knee arthroplasty – a feasibility study

Background Postoperative knee swelling is common and impairs early postoperative function following total knee arthroplasty. It was hypothesised that the use of a short-stretch, inelastic compression bandage would reduce knee swelling and improve pain and early function. The aim of this study was to provide preliminary data and test feasibility with a view to informing a larger, ...

Publishing protocols for trials of complex interventions before trial completion – potential pitfalls, solutions and the need for public debate

Background Open Science is ‘the movement to make scientific research, data and dissemination accessible to all levels of an inquiring society’. In the spirit of the Open Science movement, advance publication of protocols for clinical trials is now being advocated by BioMed Central, BMJ Open and others. Simultaneously, participants are becoming increasingly active in their pursuit ...

The effect of a novel probiotic on metabolic biomarkers in adults with prediabetes and recently diagnosed type 2 diabetes mellitus: study protocol for a randomized controlled trial

Background Shifts in the gastrointestinal microbiome have been shown to contribute to the progression of metabolic diseases including prediabetes and type 2 diabetes mellitus. Research suggests that in-vivo modulation of the gut microbiome by specific probiotic microorganisms may improve insulin sensitivity and blood sugar management, preventing or delaying the development of type ...

Prophylactic Melatonin for Delirium in Intensive Care (Pro-MEDIC): study protocol for a randomised controlled trial

Background Delirium is an acute state of brain dysfunction characterised by fluctuating inattention and cognitive disturbances, usually due to illness. It occurs commonly in the intensive care unit (ICU), and it is associated with greater morbidity and mortality. It is likely that disturbances of sleep and of the day-night cycle play a significant role. Melatonin is a naturally ...

Efficacy and safety of Lian-Ju-Gan-Mao capsules for treating the common cold with wind-heat syndrome: study protocol for a randomized controlled trial

Background The common cold is a common and frequent respiratory disease mainly caused by viral infection of the upper respiratory tract. Chinese herbal medicine has been increasingly prescribed to treat the common cold; however, there is a lack of evidence to support the wide utility of this regimen. This protocol describes an ongoing phase II randomized controlled clinical trial, ...

The efficacy of prospective memory rehabilitation plus metacognitive skills training for adults with traumatic brain injury: study protocol for a randomized controlled trial

Background Impairment of prospective memory (PM) is common following traumatic brain injury (TBI) and negatively impacts on independent living. Compensatory approaches to PM rehabilitation have been found to minimize the impact of PM impairment in adults with TBI; however, poor self-awareness after TBI poses a major barrier to the generalization of compensatory strategies in daily ...

Fenofibrate in the management of AbdoMinal aortic anEurysm (FAME): study protocol for a randomised controlled trial

Background Abdominal aortic aneurysm (AAA) is a slowly progressive destructive process of the main abdominal artery. Experimental studies indicate that fibrates exert beneficial effects on AAAs by mechanisms involving both serum lipid modification and favourable changes to the AAA wall. Methods/design Fenofibrate in the management of AbdoMinal aortic anEurysm (FAME) is a ...

Attention training for infants at familial risk of ADHD (INTERSTAARS): study protocol for a randomised controlled trial

Background Attention deficit hyperactivity disorder (ADHD) is a prevalent neurodevelopmental disorder that can negatively impact on an individual’s quality of life. It is pathophysiologically complex and heterogeneous with different neuropsychological processes being impaired in different individuals. Executive function deficits, including those affecting attention, working memory ...

Using a smartphone app to reduce cognitive vulnerability and mild depressive symptoms: Study protocol of an exploratory randomized controlled trial

Background Depression is a major challenge worldwide, with significant increasing personal, economic, and societal costs. Although empirically supported treatments have been developed, they are not always available for patients in routine clinical care. Therefore, we need effective and widely accessible strategies to prevent the onset of the very first depressive symptoms. Mental ...

A survey of facilitators and barriers to recruitment to the MAGNETIC trial

Background Recruitment to randomised controlled trials with children is challenging. It is imperative to understand the factors that boost or hinder recruitment of children to clinical trials. We conducted a survey of facilitators and barriers to recruitment to the MAGNETIC trial, using a previously developed web-based tool. Methods MAGNETIC is a multicentre randomised trial of ...

Pressure RElieving Support SUrfaces: a Randomised Evaluation 2 (PRESSURE 2): study protocol for a randomised controlled trial

Background Pressure ulcers represent a major burden to patients, carers and the healthcare system, affecting approximately 1 in 17 hospital and 1 in 20 community patients. They impact greatly on an individual’s functional status and health-related quality of life. The mainstay of pressure ulcer prevention practice is the provision of pressure redistribution support surfaces and ...

A transdiagnostic sleep and circadian treatment to improve severe mental illness outcomes in a community setting: study protocol for a randomized controlled trial

Background Severe mental illness (SMI) is common, chronic and difficult to treat. Sleep and circadian dysfunctions are prominent correlates of SMI, yet have been minimally studied in ways that reflect the complexity of the sleep problems experienced. Prior treatment studies have been disorder-focused—they have treated a specific sleep problem in a specific diagnostic group. ...

Fostering Effective Early Learning (FEEL) through a professional development programme for early childhood educators to improve professional practice and child outcomes in the year before formal schooling: study protocol for a cluster randomised controlled trial

Background A substantial research base documents the benefits of attendance at high-quality early childhood education and care (ECEC) for positive behavioural and learning outcomes. Research has also found that the quality of many young children’s experiences and opportunities in ECEC depends on the skills, dispositions and understandings of the early childhood adult educators. ...

The effect of community groups and mobile phone messages on the prevention and control of diabetes in rural Bangladesh: study protocol for a three-arm cluster randomised controlled trial

Background Increasing rates of type 2 diabetes mellitus place a substantial burden on health care services, communities, families and individuals living with the disease or at risk of developing it. Estimates of the combined prevalence of intermediate hyperglycaemia and diabetes in Bangladesh vary, and can be as high as 30% of the adult population. Despite such high prevalence, ...

Aiming to Improve Readmissions Through InteGrated Hospital Transitions (AIRTIGHT): study protocol for a randomized controlled trial

Background Hospital readmissions remain highly prevalent despite being the target of policies and financial penalties. Evidence comparing the effectiveness and costs of interventions to reduce readmissions is lacking, leaving healthcare systems with little guidance on how to improve quality and avoid costly penalties. Effective interventions likely need to bridge inpatient and ...

The incidence of training responsiveness to cardiorespiratory fitness and cardiometabolic measurements following individualized and standardized exercise prescription: study protocol for a randomized controlled trial

Background There is individual variability to cardiorespiratory fitness (CRF) training, but the underlying cause is not well understood. Traditionally, a standardized approach to exercise prescription has utilized relative percentages of maximal heart rate, heart rate reserve (HRR), maximal oxygen uptake (VO 2 max), or VO 2 reserve to establish exercise intensity. However, this ...

Detailed statistical analysis plan for a cluster randomised controlled trial of the Healthy Lifestyles Programme (HeLP), a novel school-based intervention to prevent obesity in school children

Background The Healthy Lifestyles Programme (HeLP) trial is being conducted to determine whether a novel school-based intervention is effective and cost-effective in preventing obesity in 9–10 year-old children. This article describes the detailed statistical analysis plan for the HeLP trial, including an amendment (and rationale for amendment) made to originally planned ...

Fast-track surgery after gynaecological oncological surgery: study protocol for a prospective randomised controlled trial

Background Fast-track surgery (FTS), also known as enhanced recovery after surgery, is a multidisciplinary approach to accelerate recovery, reduce complications, minimise hospital stay without increasing readmission rates, and reduce health care costs, all without compromising patient safety. The advantages of FTS in abdominal surgery most likely extend to gynaecological surgery, ...

Increasing engagement with, and effectiveness of, an online CBT-based stress management intervention for employees through the use of an online facilitated bulletin board: study protocol for a pilot randomised controlled trial

Background The evidence for the benefits of online cognitive behaviour therapy (CBT)-based programmes delivered in a clinical context is clear, but this evidence does not translate to online CBT-based stress management programmes delivered within a workplace context. One of the challenges to the delivery of online interventions is programme engagement; this challenge is even more ...

Using re-randomization to increase the recruitment rate in clinical trials – an assessment of three clinical areas

Background Patient recruitment in clinical trials is often challenging, and as a result, many trials are stopped early due to insufficient recruitment. The re-randomization design allows patients to be re-enrolled and re-randomized for each new treatment episode that they experience. Because it allows multiple enrollments for each patient, this design has been proposed as a way to ...

Impact of communication strategies to increase knowledge, acceptability, and uptake of a new Woman’s Condom in urban Lusaka, Zambia: study protocol for a randomized controlled trial

Background Globally, 220 million women experience an unmet need for family planning. A newly designed female condom, the Woman’s Condom (WC), has been developed featuring an improved design. It is the first dual-protection, female-initiated contraceptive that is a premium, higher price point product. However, market availability alone will not increase uptake. In February 2016 the ...

‘Walk This Way’ – a pilot of a health coaching intervention to reduce sedentary behaviour and increase low intensity exercise in people with serious mental illness: study protocol for a randomised controlled trial

Background People with serious mental illness (SMI) (psychosis, bipolar disorder and major depressive disorder) experience a considerable risk of premature mortality because of cardiovascular disease. Recent research has demonstrated that this population spends almost 13 h per day being sedentary. Sedentary behaviour is an independent risk factor for cardiovascular disease and ...

The effect of bundling medication-assisted treatment for opioid addiction with mHealth: study protocol for a randomized clinical trial

Background Opioid dependence has devastating and increasingly widespread consequences and costs, and the most common outcome of treatment is early relapse. People who inject opioids are also at disproportionate risk for contracting the human immunodeficiency virus (HIV) and hepatitis C virus (HCV). This study tests an approach that has been shown to improve recovery rates: ...

Early skin-to-skin contact or incubator for very preterm infants: study protocol for a randomized controlled trial

Background Skin-to-skin care immediately following delivery is a common practice for term infants and has been shown to improve cardiorespiratory stability, facilitate early bonding, and promote breastfeeding. Since 2007, the use of skin-to-skin care has been practiced for preterm infants from 32 weeks of gestation in the delivery room at St. Olav’s University Hospital. In the ...

The magnitude and temporal changes of response in the placebo arm of surgical randomized controlled trials: a systematic review and meta-analysis

Background Understanding changes in the placebo arm is essential for correct design and interpretation of randomized controlled trials (RCTs). It is assumed that placebo response, defined as the total improvement in the placebo arm of surgical trials, is large; however, its precise magnitude and properties remain to be characterized. To the best of our knowledge, the temporal ...