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University of Nottingham (UK) MAJ Il y a 4 ans

Evaluation of adjustment groups for people with Multiple Sclerosis Background and study aims? Psychological problems affect the way people cope with their disability. Depression and anxiety are common in people with multiple sclerosis (MS). Improving psychological outcomes may improve quality of life. In addition it could reduce demands on other NHS services. Although drug treatments are available, these are not appropriate for everyone. Psychological treatments may provide an alternative, but there are few high quality randomised controlled trials investigating these for people with MS. Such trials are needed in order to determine whether psychological services should be developed further. The purpose of this study was to find out whether attending group treatment sessions, which offer ways to cope with anxiety and depression, was helpful. We developed a group programme and the feedback from people who attended the groups in our pilot study was very positive. We then wished to conduct a larger study to find out whether these groups should be provided as part of routine clinical practice. The plan was to find out whether the mood of people who were offered a group treatment was better than those who were not offered the treatment and to assess the costs to the NHS of providing the service. Who can participate? People with MS who were known to the MS service in Nottingham What does the study involve? We invited people with MS to complete questionnaires about their mood. Those who had low mood, according to their questionnaire scores, were invited to take part in the study. People were allocated on the basis of chance to attend group treatment sessions or to go on a waiting list. Group A: Everyone was offered 6 fortnightly, group treatment sessions. The sessions lasted about 2 hours, with breaks, and each session had a topic of the day, such as: worry, gloom, relationships, problem solving, and the future. Group B. These people were not offered the group treatment until after the study was completed. They received all other clinical services as usual. At the end of the programme, everyone, both those who attended the group and those who did not, was asked to complete questionnaires. These included measures of mood, quality of life and the impact of MS on their lives to determine the effects of the treatment. These questionnaires were repeated 3 months later to determine whether any benefits were maintained. We also collected information on the costs of providing the service. What are the possible benefits and risks of participating? Participants may have had psychological treatment which would not otherwise have been available. There were no known risks associated with participating in this study. Where is the study run from? The MS service in Nottingham. When is the study starting and how long is it expected to run for? The study started in June 2008 and finished in September 2009 Who is funding the study? Multiple Sclerosis Society (UK) Who is the main contact? Professor Nadina Lincoln [email protected]

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University Hospital Birmingham NHS Foundation Trust MAJ Il y a 4 ans

Drug eluting balloon venoplasty in arterio-­venous fistula stenosis Background and study aims Chronic kidney disease (CKD) is a long-term condition where the kidneys do not work properly. In a healthy person, the kidneys are responsible for filtering out the waste products and excess water in the blood, and converting them into urine. In patients suffering from CKD, the kidneys are unable to do this, and so the body is unable to get rid of the waste products building up in the blood. Haemodialysis is one of the most common treatments for CKD patients, and involves diverting the blood into an external machine so that it can be “cleaned”, before being returned to the body. It requires direct access to the circulatory system (blood stream) and the best option for this is a by creating an arterio-venous fistula (AVF), which is made by surgically joining an artery and a vein in the arm. AVFs have a limited lifespan, and over time can become narrowed (stenosed) or blocked (thrombosed). The fistula can be used for haemodialysis again if it is “re-opened”. This is done by inflating a small balloon inside the fistula to flatten any blockages against the artery wall (fistuloplasty). In many cases however, the fistula re-narrows and becomes blocked again (restenosis). New techniques have been developed where the balloon used in the fistuloplasty is coated in a drug, such as Paclitaxel (drug-eluting balloon, DEB). This drug slows the growth of new smooth muscle cells in the vessel wall that may lead to re-narrowing (restenosis). The aim of this study is to find out whether a DEB is more effective than standard balloons (with no drug coating) at slowing down and preventing restenosis. Who can participate? Adults who have a narrowed AVF, which has been in use for at least 1 month. What does the study involve? Participants are randomly allocated to one of two groups. Participants in the first group receive the standard fistuloplasty procedure, in which a plain balloon is inflated until the fistula becomes wide enough to become usable. Participants in the second group receive the standard fistuloplasty procedure, in which a balloon coated in a drug called paclitaxel is used. Participants attend follow-up appointments 3, 6 and 12 months after their operation so that the openness (patency) of the fistula can be monitored. What are the possible benefits and risks of participating? Not provided at time of registration Where is the study run from? Queen Elizabeth Hospital, Birmingham (UK) When is the study starting and how long is it expected to run for? January 2016 to October 2018 Who is funding the study? Boston Scientific Corporation (USA) Who is the main contact? Mrs Nicola Anderson

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Centre for Health Science (UK) MAJ Il y a 4 ans

Effects of intravascular contrast media on platelet function in patients undergoing coronary angiography Background and study aims Thousands of patients each year require a test called a coronary angiogram. This test uses X-rays and dye (contrast) to provide cardiologists with detailed pictures of the heart arteries. There are several types of X-ray dyes used but all have the ability to cause harm and there is a small risk associated with an angiogram procedure. The two most commonly used dyes are Omnipaque and Vispaque. These is no agreement as to which is best and many centres (such as Raigmore) use both. Heart attacks and strokes are more likely if patients have ‘sticky’ blood. The purpose of this study is to find out the effects of these two dyes on the stickiness of blood. This may help doctors in the future decide which is the best dye in which patients. Who can participate? Patients who are undergoing a coronary angiogram can participate. What does the study involve? This study involves giving blood samples. This will require two blood samples taken at the start and the end of the procedure from an artery and a vein (a total of four blood samples). As you will have a small tube in both the artery and the vein as a normal part of your procedure, this will not involve any additional needles. After you have given these blood samples, the blood will be taken to the laboratory. You will not undergo any further procedures as part of this study and participation in this study will in no way change the treatment you receive. What are the possible benefits and risks of participating? There are no benefits to you taking part in this study. However, the information we get might help improve the future studies and treatment of heart patients. This study involves only the taking of an extra blood sample and no additional needles or procedures and therefore we would not expect any risk to the study participants. Where is the study run from? The study is being run by the NHS (UK) and University of the Highlands and Islands (UK). When is the study starting and how long is it expected to run for? March 2011 to March 2013. Who is funding the study? Funding for this study is from NHS Highland endowments, UK. Who is the main contact? Prof. Stephen Leslie [email protected]

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University of Southampton (UK) MAJ Il y a 4 ans

Can we enhance the social communication skills of preschool children with Autism Spectrum Conditions through play? Background and study aims Research indicates that children with Autism Spectrum Conditions (ASCs) can be taught to play via appropriate intervention, and that this may also improve their social communication skills. However, research in this area is currently lacking. We are interested in exploring whether the social interactions of preschool children with social communication difficulties can be enhanced by developing their play skills. Who can participate? Preschool children attending a Children's Centre preschool in Hampshire can attend. Children do not need to have a diagnosis of an ASC, but do need to have a funded special educational needs place at preschool relating to their social communication difficulties. What does the study involve? After consent is given, a researcher visits the child at their preschool setting to conduct some assessments. Children will then be randomly selected to either receive a short individual play intervention each day for two weeks at preschool, or to continue their preschool as usual for two weeks. The intervention, called Identiplay, lasts for 10 minutes each day and will be delivered by the child’s usual key worker. Identiplay teaches play and has been used with many preschool children with social communication needs across Hampshire. After these two weeks the researcher will visit the participant at preschool again and repeat the assessments. After a further six weeks this will be repeated. What are the possible benefits and risks of taking part? You would be helping us to understand the links between play and social communication skills in individuals with ASCs. There are no risks involved in taking part. Where is the study run from? University of Southampton (UK). When is the study starting and how long is it expected to run for? From September 2011 to March 2012. Who is funding the study? University of Southampton (UK). Who is the main contact? Miss Chloe Allen [email protected]

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VAKJP / Association of psychoanalytic child- and adolescent-psychotherapists in Germany MAJ Il y a 4 ans

Treating bulimia nervosa in female adolescents with either cognitive-behavioral therapy (CBT) or psychodynamic therapy (PDT) Background and study aims Bulimia nervosa is an eating disorder, where a person overeats (binges) and then tries to remove the food quickly by vomiting or using laxatives (purges). Bulimia is considered a mental health condition and is linked to low self-esteem, obsession with weight and food, depression and self-harm. Bulimia can affect anyone but it is more common in women and especially in teenage girls. The common way of treating bulimia nervosa is through cognitive behavioral therapy (CBT) a type of talking therapy which works on changing thoughts and behavior. However other treatments such as psychodynamic therapy (PDT), a type of talking therapy focusing on the emotional state, feelings and perceptions, could help treat the bulimia just as well or even better. However, there are no studies showing how well these treatments work with teenagers and young adults. The aim of this study is to compare these two treatments to see how well they help teenage girls reduce eating disorder symptoms and improve their mental health. Who can participate? Females aged 14-20 years old who are diagnosed with bulimia nervosa. What does the study involve? Participants are randomly allocated to one of two groups to receive 60 sessions of treatment over 12 months. Those in the first group receive CBT. This involves five phases that explore reasons for the disorder, educate about mental health, promote healthy behaviors and relationships, discuss fears about weight, eating and body shape, trains on social skills, problem solving and preventing relapsing. Those in the second group receive PDT. This involves three phases that helps participants understand the disorder affects their mind and emotional state, increasing awareness of emotional and social meanings of the symptoms, and helps apply strategies learned in the program to difficult situations. Participants are followed up 6 and 12 months after the intervention to assess their symptoms and overall mental health. What are the possible benefits and risks of participating? Participants may benefit from a reduction in eating disorder symptoms. There are no direct risks of participating. Where is the study run from? Department of Psychiatry University Hospital of Heidelberg (Germany) When is the study starting and how long is it expected to run for? May 2006 to July 2013 Who is funding the study? Association of psychoanalytic child- and adolescent-psychotherapists (Germany) Who is the main contact? Dr Annette Stefini [email protected]

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University Hospitals Bristol NHS Foundation Trust (UK) MAJ Il y a 4 ans

Outcome monitoring after cardiac surgery Background and study aims After cardiac (heart) surgery, patients routinely have a follow-up appointment six weeks after discharge. After this appointment the patient is usually referred back to the care of their general practitioner (GP) and no longer receives care from, nor is followed up by, the cardiac surgery team. This study will involve patients being monitored in the long-term after cardiac surgery (for example, to find out how many patients experience major adverse cardiac events). These data will allow audit of cardiac surgery services and provide data to investigate risk factors for poor outcomes. Who can participate? Patients aged 18 or over who have had cardiac surgery at the Bristol Heart Institute. What does the study involve? We propose to collect consent from potential participants to access their data collected in NHS databases (used for clinical care) and from Hospital Episode Statistics (HES). We are particularly interested in outcomes such as stroke or heart attack that occur after surgery. Participants will be given a choice of participating electronically or via post. If participants choose to receive postal newsletters, it will be made clear that they are providing their consent to outsource sending an annual newsletter to a mailing company. We will also ask participants to complete a questionnaire relevant to the surgery they have received and/or a quality of life questionnaire at 3 months and 12 months after the surgery. There will also be a nested study to investigate whether the presentation style and format of the paper information leaflets provided to potential participants has an effect on the consent rates to the study. Participants will be randomly allocated to receive the information in three different formats, one of which is used routinely, the other two representing new styles. The content of each format will be the same. Participants will not be informed about this nested study. What are the possible benefits and risks of participating? The main benefit to society is the provision of high quality evidence to identify areas where research may benefit patient care and inform the design of such studies. Future patients and the NHS may benefit from such research. Participants may perceive a benefit from continued contact from the centre where they had their heart surgery. This is an observational study that will not change the participants’ standard care. There are therefore no risks resulting from the study to participant safety. The main risk is reminding participants of a time that was stressful and perhaps difficult for them; however, in our experience the majority of participants do appreciate the additional follow-up. There are no risks or anticipated benefits to participants as a result of the nested study. Where is the study run from? The study is run from the Clinical Trials and Evaluation Unit Bristol, University of Bristol, and based in the Bristol Heart Institute, University Hospitals Bristol NHS Trust (UK) When is the study starting and how long is it expected to run for? January 2015 to January 2016. Who is funding the study? National Institute for Health Research (UK) Who is the main contact? Dr Lucy Culliford

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