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https://www.readbyqxmd.com/read/28526087/a-multimodal-day-treatment-program-for-multi-problem-young-adults-study-protocol-for-a-randomized-controlled-trial
#1
Marie-Jolette A Luijks, Floor Bevaart, Josjan Zijlmans, Laura van Duin, Reshmi Marhe, Theo A H Doreleijers, Henning Tiemeier, Jessica J Asscher, Arne Popma
BACKGROUND: Effective interventions for young adults with severe, multiple problems - such as psychosocial and psychiatric problems, delinquency, unemployment and substance use - are scarce but urgently needed in order to support an adequate transition to adulthood. A multimodal day treatment program called "New Opportunities" (in Dutch: "De Nieuwe Kans"; DNK) was specifically developed to target multi-problem young adults in The Netherlands. The aim of this study protocol is to describe the design of a randomized controlled trial (RCT) in clinical practice to examine the effectiveness of DNK in comparison with care as usual (CAU)...
May 19, 2017: Trials
https://www.readbyqxmd.com/read/28526046/balloon-versus-stenting-in-severe-ischaemia-of-the-leg-3-basil-3-study-protocol-for-a-randomised-controlled-trial
#2
Benjamin D Hunt, Matthew A Popplewell, Huw Davies, Lewis Meecham, Hugh Jarrett, Gareth Bate, Margaret Grant, Smitaa Patel, Catherine Hewitt, Lazaros Andronis, Jonathan J Deeks, Andrew Bradbury
BACKGROUND: Severe limb ischaemia (SLI) is defined as the presence of rest pain and/or tissue loss secondary to lower extremity atherosclerotic peripheral arterial disease. The superficial femoral and popliteal arteries are the most commonly diseased vessels in such patients and are being increasingly treated using endovascular revascularisation techniques. However, it is currently unknown whether drug-eluting stents and drug-coated balloons confer additional clinical benefits over more established techniques using plain balloons and bare metal stents, or whether they represent a cost-effective use of NHS resources...
May 19, 2017: Trials
https://www.readbyqxmd.com/read/28521838/does-the-use-of-the-informed-healthcare-choices-ihc-primary-school-resources-improve-the-ability-of-grade-5-children-in-uganda-to-assess-the-trustworthiness-of-claims-about-the-effects-of-treatments-protocol-for-a-cluster-randomised-trial
#3
Allen Nsangi, Daniel Semakula, Andrew D Oxman, Matthew Oxman, Sarah Rosenbaum, Astrid Austvoll-Dahlgren, Laetitia Nyirazinyoye, Margaret Kaseje, Iain Chalmers, Atle Fretheim, Nelson K Sewankambo
BACKGROUND: The ability to appraise claims about the benefits and harms of treatments is crucial for informed health care decision-making. This research aims to enable children in East African primary schools (the clusters) to acquire and retain skills that can help them make informed health care choices by improving their ability to obtain, process and understand health information. The trial will evaluate (at the individual participant level) whether specially designed learning resources can teach children some of the key concepts relevant to appraising claims about the benefits and harms of health care interventions (treatments)...
May 18, 2017: Trials
https://www.readbyqxmd.com/read/28521831/the-sitless-project-exercise-referral-schemes-enhanced-by-self-management-strategies-to-battle-sedentary-behaviour-in-older-adults-study-protocol-for-a-randomised-controlled-trial
#4
Maria Giné-Garriga, Laura Coll-Planas, Míriam Guerra, Àlex Domingo, Marta Roqué, Paolo Caserotti, Michael Denkinger, Dietrich Rothenbacher, Mark A Tully, Frank Kee, Emma McIntosh, Carme Martín-Borràs, Guillermo R Oviedo, Javier Jerez-Roig, Marta Santiago, Oriol Sansano, Guillermo Varela, Mathias Skjødt, Katharina Wirth, Dhayana Dallmeier, Jochen Klenk, Jason J Wilson, Nicole E Blackburn, Manuela Deidda, Guillaume Lefebvre, Denise González, Antoni Salvà
BACKGROUND: Older adults are the fastest growing segment of the world's population. Recent evidence indicates that excessive sitting time is harmful to health, independent of meeting the recommended moderate to vigorous physical activity (PA) guidelines. The SITLESS project aims to determine whether exercise referral schemes (ERS) can be enhanced by self-management strategies (SMSs) to reduce sedentary behaviour (SB), increase PA and improve health, quality of life and function in the long term, as well as psychosocial outcomes in community-dwelling older European citizens from four countries, within a three-armed pragmatic randomised controlled trial, compared with ERS alone and also with general recommendations about PA...
May 18, 2017: Trials
https://www.readbyqxmd.com/read/28521796/effects-of-nurse-telesupport-on-transition-between-specialized-and-primary-care-in-diabetic-patients-study-protocol-for-a-randomized-controlled-trial
#5
Ana Marina Moreira, Roberta Marobin, Dimitris Varvaki Rados, Camila Bergonsi de Farias, Sabrina Coelli, Bárbara Luiza Bernardi, Lívia de Almeida Faller, Laura Ferraz Dos Santos, Ana Maria Matzenbacher, Natan Katz, Erno Harzheim, Sandra Pinho Silveiro
BACKGROUND: According to the Global Diabetes Plan, a unified health system with preventive and educational strategies is essential to proper diabetes care and primary settings should be the main site of care. In Brazil, there is limited access to outpatient hospital diabetes services, while primary-care diabetes support is underutilized. Telemedicine can be a useful adjunct to support discharge of stable patients with type 2 diabetes to the primary care setting. In this paper, we present a randomized controlled trial (RCT) protocol designed to evaluate the effects of telehealth support for stable type 2 diabetes patients discharged from hospital outpatient diabetes clinics...
May 18, 2017: Trials
https://www.readbyqxmd.com/read/28514964/help-problems-in-executing-a-pragmatic-randomized-stepped-wedge-trial-on-the-hospital-elder-life-program-to-prevent-delirium-in-older-patients
#6
Noor Heim, Henk F van Stel, Roelof G Ettema, Roos C van der Mast, Sharon K Inouye, Marieke J Schuurmans
BACKGROUND: A pragmatic, stepped wedge trial design can be an appealing design to evaluate complex interventions in real-life settings. However, there are certain pitfalls that need to be considered. This paper reports on the experiences and lessons learned from the conduct of a cluster randomized, stepped wedge trial evaluating the effect of the Hospital Elder Life Program (HELP) in a Dutch hospital setting to prevent older patients from developing delirium. METHODS: We evaluated our trial which was conducted in eight departments in two hospitals in hospitalized patients aged 70 years or older who were at risk for delirium by reflecting on the assumptions that we had and on what we intended to accomplish when we started, as compared to what we actually realized in the different phases of our study...
May 17, 2017: Trials
https://www.readbyqxmd.com/read/28506285/centralised-versus-local-measurement-of-glycated-haemoglobin-in-clinical-trial-settings-a-comment-on-arch-et-al-trials-2016
#7
LETTER
Sudip Chatterjee, Richeek Pradhan
Arch and colleagues in their 24 October 2016 paper in Trials focus on the issue of centralised versus local measurement of glycated haemoglobin (HbA1c) in clinical trial settings. Resolution of the debate is important: while local HbA1c measurement is less costly, and would thereby ease the stretched funding situations for clinical trials worldwide, it cannot be implemented at the expense of clinically unacceptable disparities between centralised and localised measurements. Arch and colleagues favour centralised measurement in their paper's conclusion...
May 15, 2017: Trials
https://www.readbyqxmd.com/read/28506284/the-invest-project-investigating-the-use-of-evidence-synthesis-in-the-design-and-analysis-of-clinical-trials
#8
Gemma L Clayton, Isabelle L Smith, Julian P T Higgins, Borislava Mihaylova, Benjamin Thorpe, Robert Cicero, Kusal Lokuge, Julia R Forman, Jayne F Tierney, Ian R White, Linda D Sharples, Hayley E Jones
BACKGROUND: When designing and analysing clinical trials, using previous relevant information, perhaps in the form of evidence syntheses, can reduce research waste. We conducted the INVEST (INVestigating the use of Evidence Synthesis in the design and analysis of clinical Trials) survey to summarise the current use of evidence synthesis in trial design and analysis, to capture opinions of trialists and methodologists on such use, and to understand any barriers. METHODS: Our sampling frame was all delegates attending the International Clinical Trials Methodology Conference in November 2015...
May 15, 2017: Trials
https://www.readbyqxmd.com/read/28506281/a-telephonic-mindfulness-based-intervention-for-persons-with-sickle-cell-disease-study-protocol-for-a-randomized-controlled-trial
#9
Hants Williams, Susan Silva, Leigh Ann Simmons, Paula Tanabe
BACKGROUND: One of the most difficult symptoms for persons with sickle cell disease (SCD) to manage is chronic pain. Chronic pain impacts approximately one-third of persons with SCD and is associated with increased pain intensity, pain behavior, and frequency and duration of hospital visits. A promising category of nonpharmacological interventions for managing both physical and affective components of pain are mindfulness-based interventions (MBIs). METHODS/DESIGN: The primary aim of this study is to conduct a randomized controlled study to evaluate the acceptability and feasibility, as well as to determine the preliminary efficacy, of a telephonic MBI for adults with SCD who have chronic pain...
May 15, 2017: Trials
https://www.readbyqxmd.com/read/28499440/a-feasibility-randomised-controlled-trial-of-extended-brief-intervention-for-alcohol-misuse-in-adults-with-mild-to-moderate-intellectual-disabilities-living-in-the-community-the-ebi-ld-study
#10
Christos Kouimtsidis, Alessandro Bosco, Katrina Scior, Gianluca Baio, Rachael Hunter, Vittoria Pezzoni, Eileen Mcnamara, Angela Hassiotis
BACKGROUND: Extended brief interventions (EBIs) are effective in targeting alcohol misuse in the general population. However, little is known of the effects of EBI in adults with intellectual (also known as learning) disabilities. In this feasibility trial we compared EBI with usual care for alcohol misuse in adults with mild to moderate Intellectual Disability (ID). METHODS: The study took place in three community ID networks of services in England. Participants aged 18-65 years with reported alcohol problems, a score ≥8 on the Alcohol Use Disorder Identification Test (AUDIT), and IQ <70 (+/5%CI) were recruited and were randomly allocated to either EBI (five weekly sessions and one follow-up at 8 weeks) and usual care or usual care alone...
May 12, 2017: Trials
https://www.readbyqxmd.com/read/28494802/reducing-depressive-symptomatology-with-a-smartphone-app-study-protocol-for-a-randomized-placebo-controlled-trial
#11
Cezar Giosan, Oana Cobeanu, Cristina Mogoaşe, Aurora Szentagotai, Vlad Mureşan, Rareș Boian
BACKGROUND: Depression has become one of the leading contributors to the global disease burden. Evidence-based treatments for depression are available, but access to them is still limited in some instances. As technology has become more integrated into mental health care, computerized cognitive behavioral therapy (CBT) protocols have become available and have been recently transposed to mobile environments (e.g., smartphones) in the form of "apps." Preliminary research on some depression apps has shown promising results in reducing subthreshold or mild to moderate depressive symptoms...
May 12, 2017: Trials
https://www.readbyqxmd.com/read/28494790/erratum-to-keratinocyte-growth-factor-in-acute-lung-injury-to-reduce-pulmonary-dysfunction-a-randomised-placebo-controlled-trial-kare-study-protocol
#12
Laurence J M Cross, Cecilia M O'Kane, Cliona McDowell, Jospeh J Elborn, Michael A Matthay, Daniel F McAuley
No abstract text is available yet for this article.
May 11, 2017: Trials
https://www.readbyqxmd.com/read/28490349/cognitive-behavioural-therapy-for-the-management-of-inflammatory-bowel-disease-fatigue-with-a-nested-qualitative-element-study-protocol-for-a-randomised-controlled-trial
#13
Micol Artom, Wladyslawa Czuber-Dochan, Jackie Sturt, Christine Norton
BACKGROUND: Fatigue is one of the most prevalent and burdensome symptoms for patients with inflammatory bowel disease (IBD). Although fatigue increases during periods of inflammation, for some patients it persists when disease is in remission. Compared to other long-term conditions where fatigue has been extensively researched, optimal management of fatigue in patients with IBD is unknown and fatigue has rarely been the primary outcome in intervention studies. To date, interventions for the management of IBD-fatigue are sparse, have short-term effects and have not been implemented within the existing health system...
May 11, 2017: Trials
https://www.readbyqxmd.com/read/28482864/the-effect-of-pre-and-post-operative-physical-activity-on-recovery-after-colorectal-cancer-surgery-physsurg-c-study-protocol-for-a-randomised-controlled-trial
#14
Aron Onerup, Eva Angenete, David Bock, Mats Börjesson, Monika Fagevik Olsén, Elin Grybäck Gillheimer, Stefan Skullman, Sven-Egron Thörn, Eva Haglind, Hanna Nilsson
BACKGROUND: Surgery for colorectal cancer is associated with a high risk of post-operative adverse events, re-operations and a prolonged post-operative recovery. Previously, the effect of prehabilitation (pre-operative physical activity) has been studied for different types of surgery, including colorectal surgery. However, the trials on colorectal surgery have been of limited methodological quality and size. The aim of this trial is to compare the effect of a combined pre- and post-operative intervention of moderate aerobic physical activity and inspiratory muscle training (IMT) with standard care on post-operative recovery after surgery for colorectal cancer...
May 8, 2017: Trials
https://www.readbyqxmd.com/read/28476148/the-effectiveness-of-a-supported-self-management-task-shifting-intervention-for-adult-depression-in-vietnam-communities-study-protocol-for-a-randomized-controlled-trial
#15
Jill Murphy, Charles H Goldsmith, Wayne Jones, Pham Thi Oanh, Vu Cong Nguyen
BACKGROUND: Depressive disorders are one of the leading causes of disease and disability worldwide. In Vietnam, although epidemiological evidence suggests that depression rates are on par with global averages, services for depression are very limited. In a feasibility study that was implemented from 2013 to 2015, we found that a Supported Self-management (SSM) intervention showed promising results for adults with depression in the community in Vietnam. This paper describes the Mental Health in Adults and Children: Frugal Innovations (MAC-FI) trial protocol that will assess the effectiveness of the SSM intervention, delivered by primary care and social workers, to community-based populations of adults with depression in eight Vietnamese provinces...
May 5, 2017: Trials
https://www.readbyqxmd.com/read/28476136/effect-of-supervised-exercise-in-groups-on-psychological-well-being-among-pregnant-women-at-risk-of-depression-the-ewe-study-study-protocol-for-a-randomized-controlled-trial
#16
Lotte Broberg, Mette Backhausen, Peter Damm, Per Bech, Ann Tabor, Hanne Kristine Hegaard
BACKGROUND: Pregnant women with depression and/or anxiety prior to pregnancy are at higher risk of preterm birth, breastfeeding problems, postpartum depression, and disruption of the mother-infant attachment. It is well documented that exercise improves psychological well-being in nonpregnant subjects with symptoms of depression. However, in only a few small studies have researchers examined the effect of exercise on symptoms of depression among pregnant women. We hypothesize that physiotherapist-supervised group exercise for pregnant women at risk of antenatal depression increases their psychological well-being...
May 5, 2017: Trials
https://www.readbyqxmd.com/read/28476133/improving-practice-guidelines-for-the-treatment-of-denture-related-erythematous-stomatitis-a-study-protocol-for-a-randomized-controlled-trial
#17
Raphael F de Souza, Muhammad Faheem Khiyani, Carolina A L Chaves, Jocelyne Feine, Jean Barbeau, Ramón Fuentes, Eduardo Borie, Luciana C Crizostomo, Claudia H Silva-Lovato, Pierre Rompre, Elham Emami
BACKGROUND: Denture-related erythematous stomatitis (DES) is a chronic biofilm-mediated disease, affecting one in every three complete denture wearers. Antifungals are the treatment most commonly prescribed by oral health professionals, based on the belief that colonization by Candida spp. is the main cause of DES. However, high recurrence rates and adverse effects are commonly observed, prompting the need for practice guidelines regarding treatment. Results from our pilot study demonstrate that palatal brushing can reduce the palatal inflammation and potentially associated Candida carriage without any need for antifungal therapy...
May 5, 2017: Trials
https://www.readbyqxmd.com/read/28472974/benefit-of-dual-chamber-pacing-with-closed-loop-stimulation-in-tilt-induced-cardio-inhibitory-reflex-syncope-biosync-trial-study-protocol-for-a-randomized-controlled-trial
#18
Michele Brignole, Marco Tomaino, Arnaud Aerts, Fabrizio Ammirati, Félix Alejandro Ayala-Parades, Jean-Claude Deharo, Attilio Del Rosso, Mohamed H Hamdan, Maurizio Lunati, Angel Moya, Alessio Gargaro
BACKGROUND: The efficacy of dual-chamber cardiac pacing in neuro-mediated reflex syncope with a cardio-inhibitory response to the Tilt-Table test (TT) has not been definitively assessed so far. The lack of reproducibility of results from previous studies may be partially explained by discrepancies in subject selection and some weaknesses in design and methods. The European Society of Cardiology (ESC) has set a class IIb indication to pacemaker implantation in this population recommending further research...
May 4, 2017: Trials
https://www.readbyqxmd.com/read/28468678/sequence-balance-minimisation-minimising-with-unequal-treatment-allocations
#19
Vichithranie W Madurasinghe
BACKGROUND: Minimisation ensures excellent balance between groups for several prognostic factors, even in small samples. However, its use with unequal allocation ratios has been problematic. This paper describes a new minimisation scheme named sequence balance minimisation for unequal treatment allocations. METHODS: Treatment- and factor-balancing properties were assessed in simulation studies for two- and three-arm trials with 1:2 and 1:2:3 allocation ratios. Sample sizes were set 30, 60 and 120...
May 3, 2017: Trials
https://www.readbyqxmd.com/read/28468642/the-ciprus-study-a-nurse-led-psychological-treatment-for-patients-with-undifferentiated-somatoform-disorder-in-primary-care-study-protocol-for-a-randomised-controlled-trial
#20
Kate Sitnikova, Stephanie S Leone, Lyonne N L Zonneveld, Harm W J van Marwijk, Judith E Bosmans, Johannes C van der Wouden, Henriëtte E van der Horst
BACKGROUND: Up to a third of patients presenting medically unexplained physical symptoms in primary care may have a somatoform disorder, of which undifferentiated somatoform disorder (USD) is the most common type. Psychological interventions can reduce symptoms associated with USD and improve functioning. Previous research has either been conducted in secondary care or interventions have been provided by general practitioners (GPs) or psychologists in primary care. As efficiency and cost-effectiveness are imperative in primary care, it is important to investigate whether nurse-led interventions are effective as well...
May 3, 2017: Trials
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