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NCT ID: NCT03248245 Recruiting - Clinical trials for Interprofessional Team Collaboration

Improving Interprofessional Collaboration in Norwegian Primary Schools

Start date: April 1, 2017
Phase: N/A
Study type: Interventional

This study includes designing, implementing and evaluating the effectiveness of process-based measures for improving interprofessional collaboration in Norwegian primary schools (5-7th grades). Focusing on leadership and organizational development, the overarching aim is to improve the use of existing interprofessional competence within schools. The interventions include meetings at municipal-level (strategic), school-level (operative) and class-level (operative), with feedback procedures to ensure communication between and within all levels. Also school internal and school external collaborators are involved at all levels of intervention. In order to avoid contradictory roles, an implementation team is responsible for developing and implementing the intervention, while the research team conduct an independent evaluation. The model will be evaluated by a cluster-randomized design to evaluate the effectiveness of the intervention. The hypothesis is that schools that utilize the process-based intervention (intervention group) will improve their interprofessional team work in a way that enhances the pupil's learning- environment and teachers professional competence, self-efficacy and efficient use of working hours compared to their counterparts in the control group. We anticipate main effects to be found at pupil level, mainly through improved early assessment, intervention and efficient follow-up. The project is a collaboration between four Norwegian municipalities and includes a total of 37 Schools, half of which will be randomized to experimental condition and half to control condition. The project is financed by The Norwegian Directorate for Education and Training with a duration of three years and three months. The project is led by Professor Ira Malmberg-Heimonen. The project is a collaboration between Faculty of Social Sciences and the Work Research Institute (AFI), at Oslo and Akerhus University College of Applied Sciences. Participants in the project are Ira Malmberg-Heimonen (project leader), Anne Grete Tøge, Therese Saltkjel, Knut Fossestøl, Elin Borg and Selma Therese Lyng. Participants in the implementation team are Øyvind Pålshaugen, Hanne Christoffersen and Christian Wittrock, also from Oslo and Akerhus University College of Applied Sciences, in addition to Torbjørn Lund from the Arctic University of Norway

NCT ID: NCT03240523 Recruiting - Uterine Fibroids Clinical Trials

Assess Safety and Efficacy of Vilaprisan in Subjects With Uterine Fibroids Compare to Ulipristal

ASTEROID 5
Start date: July 31, 2017
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to assess the efficacy of vilaprisan in subjects with uterine fibroids compared to ulipristal The secondary objective of this study is to evaluate the efficacy and safety of different treatment regimens of vilaprisan in subjects with uterine fibroids

NCT ID: NCT03239249 Recruiting - Clinical trials for School Drop Out Prevention

The Cluster-randomized Evaluation of the IKO-model

IKO
Start date: March 1, 2016
Phase: N/A
Study type: Interventional

The aim of this study is to analyze whether and how a systemic school-level approach to dropout prevention (the IKO-model), increase the completion rate from upper secondary school. The hypothesis is that schools that implement the model (i.e. randomized to the experimental group), will reduce the amount of students in risk of dropout, compared to their counterparts in schools randomized to the control group. The main expected outcomes in the study are; 1) increased amounts of students in upper secondary education completing their education within the three-year standard length of education, 2) decreased amounts of school-drop out, and 3) reduced values in mediating variables, such as low achievement, course failures, lack of attendance and lack of school-motivation and -effort. Accordingly, implementation quality and fidelity to the model will be assessed, both with quantitative (survey) and qualitative (interviews and observation) data. A total of five counties and 42 upper secondary schools participate in the evaluation project. One of the counties (Akershus County) have developed and piloted the model and function as a mentor in the other four counties (Oppland, Hedmark, Nord-Trøndelag and Hamar). While 20 schools have been randomized to the experimental group, 22 schools have been randomized to the control group. Schools randomized to the control group will work as earlier with school dropout.

NCT ID: NCT03238872 Recruiting - Anxiety Clinical Trials

Trial of Prompt Mental Health Care

Start date: November 9, 2015
Phase: N/A
Study type: Interventional

Anxiety and depression are among the most common mental disorders in the population. Anxiety and depression have significant consequences at the individual, family and community level, and mental illness is estimated to cost the Norwegian society 180 billion Norwegian kroner annually. The majority of this amount is accounted for by anxiety and depression disorders. Meanwhile, access to mental health services to treat these disorders is limited. The proportion of people who do not receive treatment of those who are in need of treatment is estimated to be over 50%. Prompt Mental Health Care (PMHC) is a pilot project initiated in 2012 by the Directorate of Health commissioned by the Ministry of Health, with the goal of increasing access to evidence-based treatment for adults with anxiety disorders and mild-to-moderate levels of depression. The treatment offered is cognitive behavioural therapy and should lead to reduced levels of symptoms of anxiety and depression, improved quality of life and better employability. PMHC is based on the English program "Improving Access to Psychological Therapy (IAPT)", which is established in virtually all health communities in England. The evaluations of IAPT and PMHC have until now been based on relatively weak research designs which make it difficult to know to what extent the initiative really has the desired effect. In this study, PMHC is compared with a control group that receives treatment as usual (often provided by the general practioner) in two PMHC pilot sites (Kristiansand and Sandnes). Participants are randomly assigned to either the PMHC or the control group. The investigators aim to include 1100 clients in the study. The key objectives of this study are to investigate whether PMHC treatment is more effective as compared to treatment in the control group with regard to symptoms of anxiety and depression, work participation, functional status, and mental well-being. Cost-effectiveness of PMHC is also examined.

NCT ID: NCT03231202 Recruiting - Wounds and Injuries Clinical Trials

Splenic Injury Embolization - the Question About NOM (SInE Qua NOM)

Start date: July 1, 2017
Phase: N/A
Study type: Interventional

The primary objective is to compare the failure rate due to splenic bleeding between the patients undergoing pre-emptive splenic arterial embolization (SAE) as part of non-operative management (NOM) and the patients not undergoing SAE. We hypothesize that the use of pre-emptive SAE will decrease the delayed bleeding rate and increase the success rate of NOM.

NCT ID: NCT03221634 Not yet recruiting - Multiple Myeloma Clinical Trials

Efficacy and Safety Study of Pembrolizumab (MK-3475) in Combination With Daratumumab in Participants With Relapsed Refractory Multiple Myeloma (MK-3475-668/KEYNOTE-668)

Start date: August 1, 2017
Phase: Phase 2
Study type: Interventional

The purpose of this study is to assess the efficacy and safety of pembrolizumab (MK-3475) in combination with daratumumab in participants with relapsed refractory multiple myeloma (rrMM). The primary outcome measure for this study is the assessment of Objective Response Rate (ORR) in participants with rrMM.

NCT ID: NCT03220425 Completed - Clinical trials for Diabetes Mellitus, Type 1

Evaluation of the Efficacy and Safety of Insulin Detemir Compared With That of NPH Insulin in Subjects With Type 1 Diabetes.

Start date: February 1, 2001
Phase: Phase 3
Study type: Interventional

The aim of this trial is to evaluate the efficacy and safety of insulin detemir using the 2400 nmol/mL formulation to optimise dosing in subjects with type 1 diabetes on a basal (once daily)-bolus regimen.

NCT ID: NCT03220373 Recruiting - Clinical trials for Substance Use Disorder (SUD)

Predicting Dropout and Outcome From Neuropsychological Functions in SUD Patients

Start date: March 7, 2017
Phase: N/A
Study type: Observational [Patient Registry]

The aim of this project is to gain a more specific understanding of how different cognitive profiles predict residential treatment drop-out, treatment retention and post-treatment outcome in a population with Substance Use Disorder.

NCT ID: NCT03215342 Not yet recruiting - Brain Injuries Clinical Trials

Cognitive Rehabilitation in Pediatric Acquired Brain Injury

CORE-pABI
Start date: September 2017
Phase: N/A
Study type: Interventional

Acquired brain injury (e.g., traumatic brain injury, brain tumour, brain infections) is one of the leading causes of death and disability for children and adolescents. Importantly, injuries affecting the brain in childhood or adolescence appear during a time of development when the brain is particularly vulnerable. Thus, pediatric acquired brain injury does not only impact cognitive functions at the time of injury or onset of disease, but also cognitive functions that are yet to develop. Changes in cognitive function, and in particular executive dysfunction due to acquired brain injury, cause significant real-life disability, yet solid evidence in support of executive functioning interventions for children and adolescents is lacking. In the present study different group-based cognitive rehabilitation interventions will be compared. The aim of the study is to investigate if a group-based "brain training" intervention is able to improve executive function in children and adolescents after acquired brain injury. Efficacy will be assessed immediately after intervention, but also six months after the intervention. The project is in line with international research efforts aimed at establishing more knowledge about how children and adolescents with brain injuries respond to cognitive rehabilitation.

NCT ID: NCT03212118 Not yet recruiting - Sick Leave Clinical Trials

Effects of Motivational Interviewing for Long-term Sick Absence

Start date: August 14, 2017
Phase: N/A
Study type: Interventional

Long-term sickness absence has considerable impact on social functioning, families involved, the employer, and society as a whole. Preventing long-term sickness absence and increase the likelihood of return to work (RTW) are critical concerns for industrialized countries across the world. Motivational factors contributing to RTW and maintenance of work participation are therefore of importance to explore in order to get the person back to work after long-term sick leave. Motivational interviewing (MI) is an empirically validated psychological approach that may be particularly useful in a RTW context. Even though MI has been widely studied and is considered a flexible intervention strategy in different domains, its effectiveness in improving RTW has not yet been studied. The aim of this study is to evaluate whether MI provided by trained caseworkers at The Norwegian Labour and Welfare Administration (NAV) to sick-listed users with unselected diagnoses facilitates RTW compared with follow-up as usual.