Search results for "Randomised"
showing 10 items of 44 documents
2014
Published version of an article from the journal: Food & Nutrition Research. Also available from the publisher: http://dx.doi.org/10.3402/fnr.v58.23194 Open Access
Case Management for Depression by Health Care Assistants in Small Primary Care Practices
2009
BACKGROUND: Case management by health care assistants in small primary care practices provides unclear benefit for improving depression symptoms. OBJECTIVE: To determine whether case management provided by health care assistants in small primary care practices is more effective than usual care in improving depression symptoms and process of care for patients with major depression. DESIGN: Cluster randomized, controlled trial. A central automated system generated the randomization scheme, which was stratified by urban and rural practices; allocation sequence was concealed until groups were assigned. SETTING: 74 small primary care practices in Germany from April 2005 to September 2007. PATIEN…
Importance of proper conduct of clinical trials
2021
Factors associated with non-participation and dropout among cancer patients in a cluster-randomised controlled trial
2017
We investigated the impact of demographic and disease related factors on non-participation and dropout in a cluster-randomised behavioural trial in cancer patients with measurements taken between hospitalisation and 6 months thereafter. The percentages of non-participation and dropout were documented at each time point. Factors considered to be potentially related with non-participation and dropout were as follows: age, sex, marital status, education, income, employment status, tumour site and stage of disease. Of 1,338 eligible patients, 24% declined participation at baseline. Non-participation was higher in older patients (Odds Ratio [OR] 2.1, CI: 0.6-0.9) and those with advanced disease …
Multicentric randomised study of
2017
Introduction Population-based eradication of Helicobacter pylori has been suggested to be cost-effective and is recommended by international guidelines. However, the potential adverse effects of widespread antibiotic use that this would entail have not been sufficiently studied. An alternative way to decrease gastric cancer mortality is by non-invasive search for precancerous lesions, in particular gastric atrophy; pepsinogen tests are the best currently available alternative. The primary objective of GISTAR is to determine whether H pylori eradication combined with pepsinogen testing reduces mortality from gastric cancer among 40–64-year-old individuals. The secondary objectives include ev…
Plaque removal efficacy of power and manual toothbrushes: a comparative study
2009
The aim of this study was to compare the plaque removal efficacy of a new oscillating/rotating/pulsating toothbrush [Oral-B® Professional Care® 8500 (PC 8500)] with two manual toothbrushes [Oral-B® CrossAction™ Vitalizer (CAV) and Oral-B® Indicator™ (IND), respectively]. The safety of the PC 8500 was also assessed. The study was a single-use, observer-masked, randomised 3×3 Latin square crossover design balanced for carryover effects. The enrolled subjects (n=66) refrained from brushing for 23–25 h before each clinical examination. Plaque scores were recorded before and after brushing with the allocated toothbrush using the Turesky et al. modification of the Quigley and Hein plaque index. T…
A randomised clinical trial (RCT) of a symbiotic mixture in patients with irritable bowel syndrome (IBS): effects on symptoms, colonic transit and qu…
2012
Purpose The aim of this study is to test in a double-blinded, randomised placebo-controlled study the effects of a commercially available multi-strain symbiotic mixture on symptoms, colonic transit and quality of life in irritable bowel syndrome (IBS) patients who meet Rome III criteria. Background There is only one other double-blinded RCT on a single-strain symbiotic mixture in IBS. Methods This is a double-blinded, randomised placebo-controlled study of a symbiotic mixture (Probinul, 5 g bid) over 4 weeks after 2 weeks of run-in. The primary endpoints were global satisfactory relief of abdominal flatulence and bloating. Responders were patients who reported at least 50 % of the weeks of …
Efficacy and cost-effectiveness of a blended cognitive behavioral therapy for depression in Spanish primary health care:Study protocol for a randomis…
2018
Background: Data from primary health care in Spain show a high prevalence of the major depressive disorder. Blended treatment (combination of face-to-face and online components) seems to be a very promising tool for the optimization and dissemination of psychological treatments in a cost-effective form. Although there is growing data that confirm the advantages of blended therapies, few studies have analyzed their application in regular clinical practice. The objective of the present paper is to describe the protocol for a clinical study aimed at exploring the clinical and cost-effectiveness of a blended cognitive behavioral therapy (b-CBT) for depression, compared to treatment as usual (TA…
Protocol for developing a mental imagery intervention: a randomised controlled trial testing a novel implementation imagery e-health intervention to …
2019
IntroductionDrowning due to driving into floodwater accounts for a significant proportion of all deaths by drowning. Despite awareness campaigns such as 'If it's flooded, forget it', people continue to drive into floodwater. This causes loss of life, risk to rescuers and damage to vehicles. The aim of this study was to develop and evaluate an online e-health intervention to promote safe driving behaviour during flood events.Methods and analysisThe study will use a 2×3 randomised controlled trial in which participants are randomised into one of two conditions: (1) education about the risks of driving into floodwater or (2) education about the risks of driving into floodwater plus a theory-ba…
Evaluation of training in guideline-oriented biopsychosocial management of low back pain in occupational health services:Protocol of a cluster random…
2021
Background To prevent low back pain (LBP) from developing into a prolonged disabling condition, clinical guidelines advocate early stage assessment, risk‐screening, and tailored interventions. Occupational health services recommend guideline‐oriented biopsychosocial screening and individualized assessment and management. However, it is not known whether training a limited number of health care professionals improves the management process. The primary objective of this study is to investigate whether training in the biopsychosocial practice model is effective in reducing disability. Furthermore, we aim to evaluate health‐economic impacts of the training intervention in comparison to usual m…