Research Exploring Physical Activity in Care Homes (REACH): study protocol for a randomised controlled trial
This study is the final stage of a programme of research to develop and preliminarily test an evidence-based intervention designed to enhance opportunities for movement amongst care home residents, thereby increasing levels of physical activity.Methods/designThis is a cluster randomised feasibility trial, aiming to recruit at least 8 –12 residents at each of 12 residential care homes across Yorkshire, UK. Care homes will be randomly allocated on a 1:1 basis to receive either the intervention alongside usual care, or to continue to provide usual care alone. Assessment will be undertaken with participating residents at bas...
Source: Trials - April 19, 2017 Category: Research Source Type: clinical trials

A randomised controlled trial to determine the clinical and cost effectiveness of thulium laser transurethral vaporesection of the prostate (ThuVARP) versus transurethral resection of the prostate (TURP) in the National Health Service (NHS) – the UNBLOCS trial: a study protocol for a randomised controlled trial
DiscussionThe general population has an increased life expectancy. As men get older their prostates enlarge, potentially causing BPO, which often requires surgery. Therefore, as the population ages, more prostate operations are needed to relieve obstruction. There is hence sustained interest in the condition and increasing need to find safer techniques than TURP. Various laser techniques have become available but none are widely used in the NHS because of lengthy training required for surgeons or inferior performance on clinical outcomes. Promising initial evidence from one RCT shows that ThuVARP has equivalent clinical ef...
Source: Trials - April 17, 2017 Category: Research Source Type: clinical trials

Manubrium-limited ministernotomy versus conventional sternotomy for aortic valve replacement (MAVRIC): study protocol for a randomised controlled trial
DiscussionThis is the first trial to examine aortic valve replacement via manubrium-limited ministernotomy versus conventional sternotomy when comparing red blood cell transfusion rates following surgery. Surgical trials present significant challenges; strengths of this trial include a rigorous research design, standardised surgery performed by experienced consultant cardiothoracic surgeons, an agreed anaesthetic regimen, patient blinding and consultant-led patient recruitment. The MAVRIC trial will demonstrate that complex surgical trials can be delivered to exemplary standards and provide the community with the knowledge...
Source: Trials - January 27, 2017 Category: Research Source Type: clinical trials

Effectiveness and cost-effectiveness of a very brief physical activity intervention delivered in NHS Health Checks (VBI Trial): study protocol for a randomised controlled trial
Discussion The VBI trial will provide evidence on the effectiveness and cost-effectiveness of the Step It Up intervention delivered during NHS Health Checks and will inform policy decisions about introducing very brief interventions into routine primary care practice. Trial registration ISRCTN Registry, ISRCTN72691150. Registered on 17 July 2014. (Source: Trials)
Source: Trials - June 26, 2016 Category: Research Source Type: clinical trials

Antibiotic treatment for intermittent bladder catheterisation with once daily prophylaxis (the AnTIC study): Study protocol for a randomised controlled trial
Discussion This trial was commissioned and funded by the United Kingdom National Health Service following prioritisation of the research question by the National Institute for Health and Care Excellence. Trial registration ISRCTN67145101 EUDRACT2013-002556-32. Registered on 25 October 2013. (Source: Trials)
Source: Trials - June 3, 2016 Category: Research Source Type: clinical trials

The CORE Service Improvement Programme for mental health crisis resolution teams: study protocol for a cluster-randomised controlled trial
Discussion Our trial will show whether a theoretically underpinned and clearly defined package of resources are effective in supporting service improvement and improving outcomes for mental health crisis resolution teams. Trial registration Current Controlled Trials ISRCTN47185233 (Source: Trials)
Source: Trials - March 21, 2016 Category: Research Source Type: clinical trials

A behavioural change package to prevent hand dermatitis in nurses working in the national health service (the SCIN trial): study protocol for a cluster randomised controlled trial
Discussion This trial will assess the clinical and cost effectiveness of an intervention to prevent hand dermatitis in nurses in the United Kigdom. Trial registration ISRCTN53303171: date of registration, 21 June 2013. (Source: Trials)
Source: Trials - March 17, 2016 Category: Research Source Type: clinical trials

Negotiating excess treatment costs in a clinical research trial: the good, the bad and the innovative
Abstract Barriers to recovering the excess treatment costs associated with health research from local organisations in the United Kingdom can increase research costs, delay completion of high- quality studies and risk disenfranchising health trusts and patients from participation. The authors demonstrate how the process for recovering excess treatment costs at a local National Health Service (NHS) trust level in a multicentre study was inconsistent and resulted in excess effort and cost to the research budget. An innovative example of how an organisation acting as a broker between commissioners and re...
Source: Trials - February 9, 2016 Category: Research Source Type: clinical trials

Bypass versus angio plasty in severe ischaemia of the leg - 2 (BASIL-2) trial: study protocol for a randomised controlled trial
Discussion The BASIL-2 trial is designed to be pragmatic and represent current practice within the United Kingdom. Patients with severe limb ischaemia can only be randomised into the trial where clinical equipose exists. The advent of hybrid operating procedures should not be a barrier to randomisation, should a patient require inflow correction prior to tibial revascularisation. Trial registration ISRCTN:27728689 Date of registration: 12 May 2014. (Source: Trials)
Source: Trials - January 6, 2016 Category: Research Source Type: clinical trials