Trials
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Randomized Controlled Trial Multicenter Study
'Huang Qi Elixir' for proteinuria in patients with diabetic nephropathy: a study protocol for a randomized controlled pilot trial.
Diabetic nephropathy (DN) is the major complication of diabetes; proteinuria is the hall mark of DN. Currently, the treatment for proteinuria is mainly limited to angiotensin converting enzyme (ACE) inhibitors or angiotensin II receptor blockers (ARBs). According to Traditional Chinese Medicine (TCM) theory, Chinese medicinals 'securing essence and tonifying the kidney' may be appropriate for proteinuria. The most promising Chinese medicinals and formulae are introduced in the present study to form a potent formula for DN proteinuria. To make oral administration convenient, the formula will be processed in the form of granules. ⋯ It is notable that most published clinical trials which assessed the efficacy of TCM on DN were of poor methodology and, therefore, their results have been invalidated. It is necessary to carry out well-designed clinical trials to provide sound evidence. The present trial is a study with potentially great value, for it will provide the parameters for future randomized, placebo-controlled, clinical trials with large sample sizes.
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Randomized Controlled Trial Multicenter Study
'Help for Hay Fever', a goal-focused intervention for people with intermittent allergic rhinitis, delivered in Scottish community pharmacies: study protocol for a pilot cluster randomized controlled trial.
Despite the availability of evidence-based guidelines for managing allergic rhinitis in primary care, management of the condition in the United Kingdom (UK) remains sub-optimal. Its high prevalence and negative effects on quality of life, school performance, productivity and co-morbid respiratory conditions (in particular, asthma), and high health and societal costs, make this a priority for developing novel models of care. Recent Australian research demonstrated the potential of a community pharmacy-based 'goal-focused' intervention to help people with intermittent allergic rhinitis to self-manage their condition better, reduce symptom severity and improve quality of life. In this pilot study we will assess the transferability of the goal-focused intervention to a UK context, the suitability of the intervention materials, procedures and outcome measures and collect data to inform a future definitive UK randomized controlled trial (RCT). ⋯ This work will lay the foundations for a definitive RCT of a community pharmacy-based 'goal-focused' self-management intervention for people with intermittent allergic rhinitis. Results of the pilot trial are expected to be available in April 2013.
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Randomized Controlled Trial Multicenter Study
The impact of supported telemetric monitoring in people with type 2 diabetes: study protocol for a randomised controlled trial.
Diabetes prevalence is increasing and current methods of management are unsustainable. Effective approaches to supporting self-management are required. The aim of this randomized controlled trial is to establish whether supported telemetric monitoring of glycemic control and blood pressure results in reductions in glycosylated hemoglobin (HbA1c; the primary outcome of a measure of long-term glycemic control) and secondary outcomes of blood pressure and weight among people with poorly controlled diabetes compared to a control group receiving usual care. ⋯ Design: multi-center, randomized controlled trial with embedded qualitative study. Setting: primary care in Lothian, Kent, Glasgow and Borders regions in the UK. Participants: people with type 2 diabetes and confirmed HbA1c>7.5% (58 mmol/mol). Intervention/comparison: randomization to intervention or control groups will be performed by the Edinburgh Clinical Trials Unit. Participants in the intervention group will be shown how to use blood glucose and blood pressure monitors and weighing scales which use Bluetooth wireless technology to transmit readings via modem to a remote server. These participants will be asked to provide at least twice weekly measurements of morning and evening blood glucose and weekly measurements of weight and blood pressure. Measurements will be checked at least weekly by practice nurses who will contact the patients to adjust therapy according to guidelines and reinforce lifestyle advice. Participants in the control group will receive usual care. All participants will receive an individual education session. Follow-up: measurements will be performed at practices 9 months after randomization by research nurses blinded to allocation. The primary outcome measure is HbA1c and secondary outcomes measure are daytime systolic and diastolic blood pressure, weight and cost per quality-adjusted life year. Analysis: intention-to-treat analyses will be performed. The sample size of 320 participants allows for 20% drop-out and has 80% power at 5% significance to detect a 0.5% absolute (6 mmol/mol) fall in HbA1c in the intervention group. The qualitative study will explore the experiences of patients and professionals using the intervention.
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Randomized Controlled Trial Multicenter Study
RApid Primary care Initiation of Drug treatment for Transient Ischaemic Attack (RAPID-TIA): study protocol for a pilot randomised controlled trial.
People who have a transient ischaemic attack (TIA) or minor stroke are at high risk of a recurrent stroke, particularly in the first week after the event. Early initiation of secondary prevention drugs is associated with an 80% reduction in risk of stroke recurrence. This raises the question as to whether these drugs should be given before being seen by a specialist--that is, in primary care or in the emergency department. The aims of the RAPID-TIA pilot trial are to determine the feasibility of a randomised controlled trial, to analyse cost effectiveness and to ask: Should general practitioners and emergency doctors (primary care physicians) initiate secondary preventative measures in addition to aspirin in people they see with suspected TIA or minor stroke at the time of referral to a specialist? ⋯ This pilot study will be used to estimate key parameters that are needed to design the main study and to estimate the accuracy of primary care diagnosis of TIA. The planned follow-on trial will have important implications for the initial management of people with suspected TIA.
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Randomized Controlled Trial Multicenter Study
Improving stroke prevention in patients with atrial fibrillation.
Patients with atrial fibrillation (AF) are at increased risk for stroke. Antithrombotic treatment reduces this risk. Antithrombotic treatment consists of either administration of oral anticoagulants (OAC) or the provision of an antiplatelet drug. International guidelines provide advice on the preferred treatment, thereby balancing the risks and benefits of OAC. However, adherence to these guidelines is reported to be as low as 50%. There is paucity in research on why adherence rates are low. Recent studies have shown decision support systems can improve guideline adherence. We investigate the use of a clinical decision support system to improve guideline adherence among general practitioners (GPs) treating patients with AF and study reasons for guideline non-adherence. ⋯ This paper describes the protocol for a cluster randomized trial to study the effects of a clinical decision support system in patients with atrial fibrillation. The system is characterized by a non-interruptive presentation and real-time messages that are updated after each relevant action the GP performs.