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  • A Digital Health Intervention to Promote Self-management in Patients with Chronic Obstructive Pulmonary Disease

    This project is designed to explore aspects of acceptability and possible uncertainties associated with implementing the PDB-app as part of self-management in patients with COPD. Both quantitative and qualitative data will be collected and analysed. 50-60 patients with COPD and 15-30 physiotherapists in primary health care will be recruited. A feasibility study will be conducted and evaluated after 8-week intervention and at 6-month follow-up, using a pre-post design. Intervention: The physiotherapists will be responsible for providing the patients with training on the use of the PDB-app. Based on clinical assessment, the patients will receive a tailored treatment plan within the app. Patients are expected to engage with the tailored PDB-treatment for 8 weeks with follow-up after 6 months. If necessarily, adjustments to the treatment plan will be made throughout the intervention period. Follow-up of patients will occur digitally and physically. A qualitative interview study will be conducted with semi-structured interviews after 8 weeks of intervention for a deeper understanding of the patients' and physiotherapists' experiences with the PDB-app. Separate focus groups will be conducted with the patients and the physiotherapists. The investigators will also conduct video-recorded physiotherapy sessions at two time points during the intervention. The first one during the initial session, and then again between 3 to 6 weeks during the 8-week intervention. Subsequently, in-depth interviews, using Interpersonal Process Recall (IPR), will be conducted, with the researcher and physiotherapist, and with the researcher and patient. By using IPR interviews, video-assisted recall will help research participants access underlying experiences of their recent clinical interactions and put them into words. This means that the interaction between patient, physiotherapist and the PDB-app, experienced and recalled in the interview, relates to concrete events of the specific session. Targeting physiotherapists, the investigators aim to do a long-term follow up 6 months after the intervention and explore their experiences with having participated in IPR interviews and as participants in the study in general. How and to what degree has the IPR interview sessions and the experiences from participating in this project impacted on their clinical practice, perception of role, identity and lifeworld? The investigators will conduct individual semi-structured qualitative interviews with all the physiotherapists from the IPR interviews. Criteria for success: - At least 80% of the patients complete the intervention and the questionnaires after 8-weeks - At least 80% of the patients' complete questionnaires at 6-month follow-up - At least 90% of physiotherapists complete the study period - No adverse events by using the PDB-app - Patient satisfaction score measured with CSQ-8 ≥20 (indicate good satisfaction)

    Phase

    N/A

    Span

    313 weeks

    Sponsor

    Western Norway University of Applied Sciences

    Bergen

    Recruiting

  • The Norwegian Immunotherapy in Multiple Myeloma Study

    Phase

    N/A

    Span

    672 weeks

    Sponsor

    St. Olavs Hospital

    Bergen

    Recruiting

  • EUthyroid2: the Next Step Towards the Elimination of Iodine Deficiency and Preventable Iodine-related Disorders in Europe

    BACKGROUND: Iodine deficiency (ID) is a leading risk factor for the development of thyroid disorders, of which in particular women are affected. During pregnancy, ID can increase the risk of developmental disorders in the offspring, however, it is considered as one of the most preventable causes of mental impairment in children. Therefore, the EUthyroid2 project aims to contribute to the prevention of ID and associated symptom and disease burden in adolescence and young women in Europe and beyond. AIM: An educational intervention is to be developed, implemented in ambulatory care settings and evaluated to effectively raise awareness for the risks of ID among young women (18-24 years) in three European countries (Norway, Poland, UK) as well as Bangladesh and Pakistan. METHODS: A cluster-randomised controlled trial is to be conducted in each of the five countries. 10 clusters per country (5 intervention group clusters and 5 control group clusters) are planned to achieve a final sample size of 200 study participants per implementing country with one baseline (before the intervention) and two follow-up measurements (2-4 weeks and 6-8 months after the intervention). In all, 1000 participants are to be recruited and data for all measurement points collected. Due to differences in the healthcare systems, the ambulatory care units, where the intervention will be implemented, may vary across the countries. Before recruiting the women, the healthcare professionals who carry out the intervention will receive a specially designed training program. To assure the intervention's functionality and effectiveness, recommendations for the development of complex interventions, appropriate theories and frameworks will be considered and a context analysis will be conducted. The primary outcome of the study is iodine awareness and knowledge measured by a newly developed questionnaire. Other outcomes includes measurement of iodine status (urinary iodine concentration), intake of dietary iodine sources (measured by a food frequency questionnaire), and iodine related behaviours. Sociodemographic characteristics and general dietary habits will also be measured. Descriptive analyses for all variables will be performed. Intervention groups will be compared to control groups over time to test effectiveness. Subgroup and country-specific analyses will also be computed. A process evaluation will be conducted to evaluate the implementation process with a convergent parallel mixed methods design. For this, healthcare professionals in the ambulatory care settings and the women who received the intervention will be invited to participate in an online survey. Further, ca. 20-30 semi-structured interviews will be conducted with women and healthcare professionals. CONCLUSION / OUTLOOK: The project results may support health authorities across countries to implement effective measures to reduce ID and associated risks. This may sustainably reduce the disease burden induced by ID for young women, pregnant women and their offspring.

    Phase

    N/A

    Span

    59 weeks

    Sponsor

    EUthyroid

    Bergen

    Recruiting

    Healthy Volunteers

  • Electronic Cardiac Rehabilitation (eCardiacRehab) Feasibility Study

    Phase

    N/A

    Span

    565 weeks

    Sponsor

    Haukeland University Hospital

    Bergen

    Recruiting

  • Improving Diagnostics and Care After First Seizure

    Phase

    N/A

    Span

    209 weeks

    Sponsor

    Haukeland University Hospital

    Bergen

    Recruiting

  • Effects of Delayed School Start Times on Sleep, Mental Health, and Academic Performance Among Norwegian Adolescents

    The current study is a randomized controlled study investigating whether later school start times on Mondays and Tuesdays have positive impact on high school students' sleep patterns, mental health, and daytime functioning. 1st year high school students are randomly assigned to classes starting either two hours later on Mondays and one hour later on Tuesday and ordinary school start times (8:15 ± 15 min) for the rest of the week, or to classes starting at regularly school start times (8:15 ± 15 min.) all weekdays. The students will be invited to respond to a web-based survey assessing sleep, mental health, and daytime functioning by the beginning and end of the school year. Official school grades and school absence data will be collected through the county administration for consenting students. Cognitive tests and objective sleep record through Somnofy are planned for a subgroup by the end of the 2024-25 school year. The study will last for two school years and involve two different cohorts of 1st year high school students.

    Phase

    N/A

    Span

    98 weeks

    Sponsor

    University of Bergen

    Bergen, Vestland

    Recruiting

    Healthy Volunteers

  • Feasibility Trial of a Guided Internet-delivered Intervention for Adolescents with ADHD

    ADHD is one of the most prevalent diagnoses in childhood. Treatment guidelines recommend inclusion of psychological support, however, there are currently few psychological treatment options for adolescents with ADHD. The current study investigates the feasibility and preliminary effects of therapist-guided digital treatment for adolescents with ADHD using qualitative and quantitative methods. The project uses the person-based approach (PBA) as methodological framework, which is an evidence-based method for developing user-centered and effective behavior change interventions. The study seeks the examine the intervention within five feasibility domains that includes the following research questions 1. Recruitment 1A. How long does it take to recruit 60 adolescents with ADHD? 1B. Is the target group represented in the sample? 2. Adherence 2A. Does a minimum of 50% complete the intervention? 2B. What characterizes the adolescents who complete the intervention? (predictor) 2C. What characterizes the adolescents who dropout of the intervention? (predictor) 3. Credibility 3A. Will at least 70% of the adolescents recommend the program to a friend with similar challenges? 4. Satisfaction 4A. How satisfied are the adolescents with the intervention? 4B. What are the adolescents' experiences with the intervention? (qualitative feedback) 5. Preliminary clinical outcomes 5A. Will a moderate effect (d = 0.5) on outcomes related to everyday functioning, quality of life and ADHD symptoms be found? 5B. Will more than 40% of the participants experience reliable clinical change (RCI) on the primary clinical outcomes? 5C. Will less than 10% of the participants experience negative clinical effects, defined as a negative RCI? Youth between the ages of 13 to 16 years and their parents will be invited to participate in this study. The participants will be recruited via child and youth psychiatric outpatient clinics. Eligible participants get access to an online information consent form which is signed digitally using the Norwegian electronic identification system BankID. Data will be collected using self-report questionnaires administrated online at pre-, during, post- and 3- and 6-months follow-up. The investigators will also conduct semi-structured phone interviews to explore the patients' in-depth experience of the digital treatment. The interviews of approximately 16 adolescents will be conducted 2 to 4 weeks after finishing the treatment. The investigators will strive to have two groups, one with participants that completed the treatment, and one with dropouts.

    Phase

    N/A

    Span

    67 weeks

    Sponsor

    Haukeland University Hospital

    Bergen

    Recruiting

  • Comparison of Hemanext ONE® System and Conventional Red Blood Cell Transfusion

    The primary objective is to evaluate whether the total number of hypoxically stored red blood cell (RBCs) units per unit of time transfused in patients with haematologic malignancies, requiring chronic blood transfusion therapy, is non-inferior to the total number of units of conventionally stored RBCs per unit of time transfused. Secondary objectives include the following: 1. Analysis of volume of blood transfused 2. Analysis of number of transfusion events throughout the study period 3. Key laboratory assessments (hemoglobin and hematocrit) and average hemoglobin increment after transfusions of hypoxically stored RBCs compared to that with conventionally stored RBCs 4. Evaluation of Quality of Life (QoL) 5. Change in serum ferritin 6. Safety assessment

    Phase

    N/A

    Span

    107 weeks

    Sponsor

    Hemanext

    Bergen

    Recruiting

  • Personalized Training for People With Rare Neuromuscular Disorders

    Phase

    N/A

    Span

    212 weeks

    Sponsor

    Oslo University Hospital

    Bergen

    Recruiting

  • Feasibility of a Life Coping Program: a Study Protocol

    Feasibility and acceptability of the intervention Life Coping Program will be evaluated in an uncontrolled open-label trial using quantitative measures. Sixty children or adolescents with chronic illness or severe medical condition will be recruited along with one associated caregiver. Feasibility will be assessed by tracking attendance and participation in different parts of the intervention. Acceptability of the intervention will be assessed using patient reported experience measures (PREM). Health related quality of life (HrQoL) and level of physical activity will be measured using the Kidscreen 27 and Actigraph GT3X+ monitor, respectively, at baseline and post-intervention. The study is based on the British Medical Research Council's (MRC) framework for developing and evaluating complex interventions, and will explore innovative treatment strategies that could potentially improve current clinical outcomes and reduce the need for ongoing healthcare follow-up. The findings from this feasibility study will lay the groundwork for a future definitive randomized controlled trial in accordance with the MRC framework for developing and evaluating complex interventions.

    Phase

    N/A

    Span

    109 weeks

    Sponsor

    Haukeland University Hospital

    Bergen, Vestland

    Recruiting

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