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Determining the Feasibility of Ambulance-Based Randomised Controlled Trials in Patients with Ultra-Acute Stroke: Study Protocol for the “Rapid Intervention with GTN in Hypertensive Stroke Trial” (RIGHT, ISRCTN66434824)
Published 2012-01-01“…RIGHT is an ambulance based, single-blind, randomised controlled trial with blinded-outcome assessment. …”
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The effect of psychosocial stimulation on the development, nutrition, and treatment outcomes of hospitalised children with severe acute malnutrition in Southern Ethiopia: a cluster randomised control trial: EPSoSAMC study
Published 2025-01-01“…The study aimed to examine the effects of psychosocial stimulation on the development, nutrition, and treatment outcomes of hospitalised SAM children. A cluster-randomised controlled trial was conducted among health facilities that provide inpatient care for children with SAM in Silti Zone, Ethiopia. …”
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Effects of community family doctors-led intervention for self-management and medication adherence in type 2 diabetes mellitus patients: study protocol of a cluster randomised controlled trial
Published 2022-07-01“…This protocol describes a planned randomised controlled trial to evaluate the effectiveness of a family doctor-led intervention model for diabetes self-management and medication adherence in type 2 diabetes mellitus patients.Methods and analysis This is a Standard Protocol Items: Recommendations for Interventional Trials-compliant cluster randomised controlled trial. …”
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HER-SAFE study design: an open-label, randomised controlled trial to investigate the safety of withdrawal of pharmacological treatment for recovered HER2-targeted therapy-related cardiac dysfunction
Published 2025-02-01“…The need to continue HFT in ‘recovered’ HER2 CTRCD following completion of HER2 therapy is unclear and there are potential significant impacts on patient’s quality of life (QoL). The Randomised Controlled Trial for the Safety of Withdrawal of Pharmacological Treatment for Recovered HER2 Targeted Therapy Related Cardiac Dysfunction (HER-SAFE) aims to evaluate whether HFT can be safely withdrawn in non-high cardiovascular (CV) risk patients with ‘recovered’ HER2 CTRCD.Methods and analysis This is a multicentre, open-label randomised controlled trial investigating whether withdrawal of HFT is non-inferior to continuation in non-high CV risk, breast cancer survivors with recovered HER2 CTRCD after cancer treatment completion. …”
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Alpha-2-adrenergic receptor agonists for the prevention of delirium and cognitive decline after open heart surgery (ALPHA2PREVENT): protocol for a multicentre randomised controlled trial
Published 2022-06-01“…We aim to study whether repurposing of clonidine can represent a novel treatment option for delirium, and the possible effects of dexmedetomidine and clonidine on long-term cognitive trajectories, motor activity patterns and biomarkers of neuronal injury, and whether these effects are associated with frailty status.Methods and analysis This five-centre, double-blind randomised controlled trial will include 900 cardiac surgery patients aged 70+ years. …”
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Accepting your Body after Cancer (ABC), a group-based online intervention for women treated for breast cancer: study protocol for a feasibility randomised controlled trial
Published 2025-01-01“…Therefore, we aim to establish the feasibility of conducting a fully powered randomised controlled trial to evaluate online delivery of ABC.Methods and analysis 120 women who have received treatment for breast cancer and are experiencing body image concerns will be randomised equally to either the ABC or standard care control group. …”
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Rehabilitation using virtual gaming for Hospital and hOMe-Based training for the Upper limb in acute and subacute Stroke (RHOMBUS II): results of a feasibility randomised controlled trial
Published 2025-01-01“…Recruitment, training and support were manageable and completion of data was good, indicating that a future randomised controlled trial would be feasible.Trial registration number ISRCTN11440079.…”
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Understanding recruitment to a perioperative randomised controlled trial: protocol for a mixed-methods substudy nested within a feasibility trial of octreotide infusion during liver transplantation
Published 2022-07-01“…Introduction Recruitment to perioperative randomised controlled trials is known to be challenging. Qualitative methods offer insight into barriers and enablers to participation. …”
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Cluster randomised controlled trial on the effects of long-term home-based exercise for patients with chronic obstructive pulmonary disease with recent exacerbation: research protocol of the COPDtoParis Project
Published 2025-01-01“…This study aims to investigate the effects, experiences and acceptability of long-term home-based cycling for patients with COPD post exacerbation.Methods and analyses This cluster randomised controlled trial will recruit hospitalised patients with COPD following hospitalisation following exacerbation of COPD. …”
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Effect of eHealth-delivered exercise programmes on balance in people aged 65 years and over living in the community: a systematic review and meta-analysis of randomised controlled trials
Published 2022-06-01“…This systematic review and meta-analysis synthesised the evidence and evaluated the effect of eHealth-delivered exercise programmes compared with control on balance in community-dwelling people aged ≥65 years.Methods Nine databases including MEDLINE, CINAHL and Embase, were searched from inception to January 2022 to identify randomised controlled trials evaluating eHealth-delivered exercise programmes for community-dwelling people aged ≥65 years, published in English that included a balance outcome. …”
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Barriers and facilitators of loaded self-managed exercises and physical activity in people with patellofemoral pain: understanding the feasibility of delivering a multicentred randomised controlled trial, a UK qualitative study
Published 2019-06-01“…The purpose of this study was to explore potential barriers and facilitators with patients and physiotherapists with patellofemoral pain involved in a feasibility randomised controlled trial (RCT) study. The trial investigated a loaded self-managed exercise intervention, which included education and advice on physical activity versus usual physiotherapy as the control.Design Qualitative study, embedded within a mixed-methods design, using semi-structured interviews.Setting A UK National Health Service physiotherapy clinic in a large teaching hospital.Participants Purposively sampled 20 participants within a feasibility RCT study; 10 patients with a diagnosis of patellofemoral pain, aged between 18 and 40 years, and 10 physiotherapists delivering the interventions.Results In respect to barriers and facilitators, the five overlapping themes that emerged from the data were: (1) locus of control; (2) belief and attitude to pain; (3) treatment expectations and preference; (4) participants’ engagement with the loaded self-managed exercises and (5) physiotherapists’ clinical development. …”
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Comprehensive self-tracking of blood glucose and lifestyle with a mobile application in the management of gestational diabetes: a study protocol for a randomised controlled trial (eMOM GDM study)
Published 2022-11-01“…The principal aim of this study is to evaluate the effects of comprehensive and real-time self-tracking with eMOM GDM mobile application (app) on glucose levels in women with GDM, and more broadly, on different other maternal and neonatal outcomes.Methods and analysis This randomised controlled trial is carried out in Helsinki metropolitan area. …”
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It’s safe to move! A protocol for a randomised controlled trial investigating the effect of a video designed to increase people’s confidence becoming more active despite back pain
Published 2022-07-01“…This trial aims to investigate the effectiveness of a public health campaign to increase people’s confidence in becoming more active despite low back pain in comparison with no intervention.Methods and analysis This is an online randomised controlled trial with two intervention groups and one control group in a 1:1:1 allocation. …”
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Trabeculectomy versus stepwise treatment for breaking the attack of acute primary angle closure in patients with long attack duration: study design and protocol for a multicentre randomised controlled trial (LAAAC)
Published 2025-02-01“…Since prompt and effective treatment is pivotal in preserving visual function as well as avoiding APAC-induced blindness, direct trabeculectomy may largely benefit long-attacking patients with APAC in China.Purpose The Long-Attacking Acute Angle Closure study aims to compare long-term visual function and safety after different initial treatment strategies: direct surgery (trabeculectomy) or stepwise protocol for patients with APAC with attack duration longer than 72 hours.Methods and analysis This is a pragmatic, multicentre, randomised controlled trial targeting Chinese patients with APAC duration longer than 72 hours. …”
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