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IDIAP Jordi Gol (Spain) MAJ Il y a 4 ans

Effectiveness and cost-effectiveness of a health coaching intervention to improve the lifestyle of patients with knee osteoarthritis Background and study aims The overall prevalence of osteoarthritis in the Spanish population is 17% and the prevalence of osteoarthritis of the knee is 10.2%. Osteoarthritis of the knee is a condition which affects patients’ social and personal lives and it requires highly specialised care. Most clinical guidelines recommend starting treatment with a non-pharmacological approach which should include weight loss, healthy diet, physical exercise, self-management of pain, educational activities and orthotics. Some studies show that only 10% of the population adopts the healthy lifestyle required for active and healthy ageing and more specifically, for the successful management of osteoarthritis of the knee. While patients are generally aware of what a healthy lifestyle implies, they find it difficult to implement the necessary changes. Health Coaching is a behavioural intervention that assists patients in achieving health goals and behavioural changes, in minimizing unhealthy habits, improving self-management of chronic conditions and increasing quality of life (QOL). The main aim of the study is to assess the effectiveness, cost-effectiveness and cost-utility of an intervention based on Health Coaching with support phone calls on QOL, pain, overweight/obesity and physical activity in patients with osteoarthritis of the knee from primary care centres (PCCs) of Barcelona. Who can participate? Primary care patients with diagnosis of knee osteoarthritis. What does the study involve? The primary health care centres will be randomly allocated to the intervention group or the control group. The intervention group will attend 20 hours of group coaching with follow up and support phone calls. The control group will be managed as per usual. What are the possible benefits and risks of participating? If the intervention shows cost-effectiveness and cost-utility in promoting healthy lifestyles and active ageing, the results will be included in the clinical guidelines for the management of osteoarthritis of the knee. There are no possible risks of participating in the study. Where is the study run from? Primary care centres (PCCs), Barcelona. When is the study starting and how long is it expected to run for? The study is expected to start in early 2014. Who is funding the study? The study is not funded at the moment, but it has been sent to three competitive scientific grants. Who is the main contact? Dr Anna Berenguera

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Department of Health MAJ Il y a 4 ans

Writing to patients to encourage them to report symptoms to their GP Background and study aims Diagnosis of cancer during late stages of the disease and the resultant poor survival is more common in those from disadvantaged backgrounds, among certain ethnic groups, among those suffering from more other health conditions and among those first presenting with cancer to emergency medical services. Other possible factors which may make patients more likely to first present to healthcare services during the late stages of cancer include infrequent contact with their general practice, lack of engagement in cancer screening, and possibly a tendency to use acute or emergency services in preference to primary care. Previous initiatives (such as The Be Clear on Cancer Campaigns) took the form of television and radio advertisements and posters which were aimed at the public in general. For both financial and public health reasons, it is advantageous to target these programs towards those least likely to seek help for symptoms and those most at risk of advanced stage disease at diagnosis. If successful this might then lead to cancer diagnoses being made an earlier point when the cancer is at a more treatable stage. Targeted programs also provide the opportunity to tailor the programs so that it is most likely to appeal to the specific audience. The aim of this study is to find out whether a targeted program aimed at those at risk of presenting with late-stage cancer results in increased engagement with primary care. Who can participate? General Practices from three geographical clusters (London, Manchester and The North of England) have been invited to participate. From their patients they will select approximately seventy who are eligible. These are adults aged between 50 and 84 who have not seen their GP for a year and come from a disadvantaged background; missed their last cancer screening; have a history of using out of hours or emergency services rather than seeing a GP; missed their last appointment for long-term disease management; have low social support; or have ever smoked. What does the study involve? Selected patients are randomly allocated to one of two groups. Those in the first group receive normal care only. Those in the second group receive normal care and also receive a cancer awareness leaflet and letter by post. At the end of six months, patients' usual care teams record the number of and type of consultations attended by all selected patients during that six month period to compare whether there are any significant differences between the amount of patients going to see their GP in the two study groups. What are the possible benefits and risks of participating? Of those patients that are randomly assigned to receive the intervention some may already have symptomatic cancer but have not reported it to a health professional. As a result of the intervention these patients may arrange a consultation with their general practitioner. This in turn could lead to an earlier diagnosis of cancer and result in improved health outcome and a better chance of survival. Some other patients that are randomly assigned to receive the intervention may have symptoms that appear cancerous but are in fact benign or represent a different disease. This group may benefit from being reassured by their doctor that their symptoms are not a cause for concern or alternatively from appropriate treatment. Though both leaflet and letter are designed to re-engage members of hard to reach populations with primary care it is possible that it could generate anxiety in patients. In order to reduce these risks both the leaflet and letter have been written deliberately in a way that aims to minimise anxiety. Where is the study run from? Wolfson Institute of Preventive Medicine (UK) When is the study starting and how long is it expected to run for? June 2016 to December 2017 Who is funding the study? Department of Health (UK) Who is the main contact? Dr Jean-Pierre Laake

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Biogen GmbH MAJ Il y a 4 ans

ZEUS - ZINBRYTA real world use study in Germany Background and study aims Multiple sclerosis (MS) is a chronic (long-term) inflammatory disease of the central nervous system (brain and/or spinal cord). More than 2 million people are affected worldwide. Most MS patients (90%) suffer from relapsing remitting MS, where they have episodes of new or worsening symptoms (e.g., vision problems, numbness, muscle weakness), known as relapses, which then slowly improve. Relapses are often reversible to begin with, but over time there is a slow deterioration of neurological functions. The aim of this study is to collect further data on the effectiveness and safety of the drug daclizumab, which is used to treat relapsing MS. Who can participate? Patients aged 18 and over with relapsing remitting MS who are starting treatment with daclizumab What does the study involve? Participants are followed for up to 60 months after starting treatment or until death, withdrawal, or the participants is considered lost to follow up, whichever occurs first. Follow up is planned regardless of whether treatment with daclizumab is stopped, unless informed consent is withdrawn or a participant joins another study. Assessments are completed and data is collected at the start of the study, 3 and 6 months after starting daclizumab treatment, and every 6 months thereafter for up to 60 months. The proportion of patients who still are on treatment with daclizumab, their reasons for stopping treatment, treatment adherence, relapses, progression of disability and side effects are all measured at each visit. What are the possible benefits and risks of participating? No benefits or risks are expected. Where is the study run from? 160 sites, led by Carl Gustav Carus Management GmbH, university hospital, clinic for neurosciences (Germany) When is the study starting and how long is it expected to run for? December 2016 to June 2023 Who is funding the study? Biogen GmbH (Germany) Who is the main contact? Dr Nadia Spitznagel [email protected]

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University of Concepción MAJ Il y a 4 ans

Efficacy of a positive parental practices promotion program in families of Chilean pre-school children Background and study aims It is generally considered that children’s experiences can help to shape their development. There is a lot of evidence that suggests that early parenting interventions (programs) can significantly enhance parenting skills, as well as parent-child relationships and child wellbeing. A growing number of children show signs of behavioral problems at home and at school. Many studies have shown that this problem behavior in young children can get worse with age, and so it is important that behavioral problems are addressed early on to ensure healthy childhood development. Parenting interventions have been proven to be very successful at improving child behavior. The most effective of these programs are shown to teach parents how to stimulate and encourage good behaviour and appropriately deal with bad behaviors, while avoiding being overly punitive (inflicting punishment) and harsh. This study is looking at a new parenting intervention called the Day UdeC Program, which has been designed at the University of Concepción. The aim of this study is to test whether the Day UdeC Program can help to improve parenting practices and parent-child relationships. Who can participate? Families with pre-school age children (between 2 and 6) who attend educational centres in Concepcion, Chile. What does the study involve? Educational centres are randomly allocated to one of two groups. Parents/guardians of children who attend educational centres in the first group take part in the Day UdeC Program. This involves attending six, weekly sessions which last for around two hours. In these sessions, parents/guardians are taught skills to strengthen their relationship with their children and learn positive discipline strategies (helping the child to develop a conscience so that they behave properly in a loving and supportive way). Those in the second group do not take part in the Day UdeC Program during the study period, but are able to attend the program after all of the study assessments have been completed. At the start of the study and then again after the program ends (8-9 weeks), participants in both groups complete a number of questionnaires in order to test their parenting skills as well as their overall mood. What are the possible benefits and risks of participating? Participants may benefit from being able to improve their parenting skills. There are no risks involved with taking part in this study. Where is the study run from? Educational centers (public and subsidized schools, and centers from JUNJI and Integra Foundation) in Concepcion (Chile) When is the study starting and how long is it expected to run for? March 2015 to October 2016 Who is funding the study? National Commission for Scientific and Technological Research FONDEF Program Ideas (Chile) Who is the main contact? Dr Félix Cova [email protected]

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

Evaluating how best to train classroom teachers to deliver mindfulness training competently in school settings Background and study aims This study has a number of aims. First it is examining the feasibility of recruiting and training teachers in a mindfulness curriculum. For example it is considering questions such as how many teachers/schools need to be contacted to achieve a given number of teachers consenting to participate in a study of teacher training, and how many of those teachers who consent end up completing training and going on to deliver the curriculum in their school? Understanding these feasibility issues is important in planning for a future study that will involve training teachers to deliver a mindfulness curriculum prior to examining the impact of this curriculum on young people. The study is also exploring how best to train secondary school teachers to teach a mindfulness curriculum to their pupils. To do so the study will compare four different training routes. We will compare the training routes in terms of the levels of competency teachers achieve and their associated costs (both in terms of financial cost and time). An additional aim is to examine the impact of personal mindfulness training on teacher wellbeing, in particular levels of perceived stress and wellbeing. The study will compare the impact of face-to-face and self-help personal mindfulness training on these measures. Who can participate? Teachers currently teaching in a mainstream secondary school in England. What does the study involve? At the start of the study, participating teachers are asked to complete online questionnaires. Participating schools are randomly assigned to one of four training routes. The first training route is the one that teachers currently follow if they want to train to teach mindfulness to their pupils. In this training route teachers first complete an 8-week face-to-face personal mindfulness training and then follow a four-day syllabus training. This training route is quite time consuming and expensive and we do not know the levels of competency achieved by teachers following this training route. Therefore this study compares this training route with three alternative, lower intensity training routes. These routes comprise: face-to-face personal mindfulness training combined with a briefer, one-day syllabus training; self-help personal mindfulness training combined with 4-day syllabus training; and lastly self-help mindfulness training combined with 1-day syllabus training (the lowest intensity training route). Teachers are told what training they will receive and are provided with the materials they need, including, if relevant, access to a class and mindfulness instructor. Usually face-to-face mindfulness training takes place in the teachers’ school or in some cases at a nearby school. Once teachers have completed their personal mindfulness training they are asked to complete an online assessment. Following this assessment they are informed of the syllabus training they will receive (either 1 day or 4 day training) and go on to receive this training. Following completion of syllabus training teachers complete a final online assessment. They then return to their schools and plan to deliver the curriculum. They video record all their classes and submit these for assessment of teaching competency. What are the possible benefits and risks of participating? All participating teachers will benefit from receiving free high quality training in personal mindfulness and in the delivery of the .b mindfulness in schools curriculum. Schools will benefit because training is provided free of charge and money is available to pay for supply cover whilst teachers are out of school receiving training, so they will improve the training of members of their workforce at no cost. All participating teachers receive a £100 book voucher on submission of their training videos. Additionally each participating school will receive a £250 voucher at the end of the study. There are no known risks of taking part in the study. However, the training does involve a significant time commitment as teachers are asked to practice mindfulness exercises 6 days a week and also to engage in other course-related activities. Finally teachers are required to complete questionnaires on four occasions during the study and then to video themselves teaching the .b curriculum. Where is the study run from? The study is run from University of Oxford (UK) and takes place in a number of schools based in Oxford (UK) When is the study starting and how long is it expected to run for? June 2015 to March 2018 Who is funding the study? Wellcome Trust (UK) (Grant reference: 104908/Z/14/z) Who is the main contact? Dr Catherine Crane

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