Arendal

Researchers are evaluating a complex intervention to improve advance care planning ACP for severely ill elderly people living at home who are acutely admitted to hospital. This cluster randomized study involves twelve Norwegian geriatric hospital units and aims to enhance patient and family involvement in treatment decisions, improve quality of life, and support ethical and legal care planning. The project also explores barriers and facilitators to implementing ACP at clinical, health service, and governmental levels, including economic analyses. The intervention group receives a comprehensive support program that includes leadership commitment, training for staff, implementation teams, ACP coordinators, and practical tools such as guidelines and documentation templates. The control group receives no implementation support during the trial but will be offered the program afterward. The study period includes baseline, 9-month, and 18-month assessments for the intervention group and baseline and 18-month assessments for the control group. Participants will undergo questionnaires and interviews with patients, relatives, clinicians, and staff at multiple time points before, during, and after the implementation. Data from patient records and national health registers will be collected to assess the fidelity of ACP implementation, clinical outcomes, communication quality, and cost-effectiveness. The trial runs until December 2026 and includes various measures to evaluate the impact of the support program on ACP delivery and related outcomes.

Massive rotator cuff tears affect about 12% of adults aged 60 or older, with 40% of these injuries classified as massive. These tears cause significant pain and have limited treatment options. This research investigates a new surgical treatment involving a biodegradable balloon spacer for patients with massive rotator cuff tears. The study is a randomized controlled trial comparing the new treatment with standard arthroscopic surgery. Participants undergo arthroscopic debridement and biceps tenotomy, then are randomly assigned to either receive the biodegradable subacromial spacer or not. Before randomization, the surgeon assesses if the patient is a candidate for partial suture to balance the groups. Post-surgery, patients follow a rehabilitation plan including immobilization, gradual shoulder mobilization, and progressive weight lifting over 12 weeks. During the study, participants are evaluated using the Constant score before surgery and repeatedly up to 10 years after. Additional assessments include shoulder X-rays, pain scales VAS, quality of life questionnaires Eq-5D, and the WORC index at various intervals. The study uses double-blinding for patients and physiotherapists, with the surgeon aware of group assignment but not involved in testing. Follow-up visits and functional tests will monitor outcomes and safety over time.

Researchers are evaluating whether D-serine, a co-agonist of the N-methyl-D-aspartate receptor NMDAR, can improve symptoms and slow progression in Parkinsons disease PD. This randomized, double-blind, placebo-controlled trial involves 100 participants diagnosed with PD within the past 5 years. The study aims to measure changes in clinical severity using the Movement Disorder Society Unified Parkinsons Disease Rating Scale MDS-UPDRS, along with dopaminergic brain activity and cognitive function. Participants will be randomly assigned to two groups that receive both D-serine and placebo during different study periods over 58 weeks. D-serine dosing starts with 2 capsules of 500 mg twice daily in the first week and increases to 4 capsules twice daily thereafter, while placebo capsules are given similarly. After the intervention phase, a 12-week washout period will follow where the study drug is stopped, with a final visit 12 weeks after discontinuation. During the study, participants will undergo clinical evaluations including rating scales and questionnaires, cognitive testing, blood sampling, and dopamine transporter imaging via SPECT scans. Researchers will closely monitor motor and non-motor symptoms, brain dopamine function, and cognitive changes. The trial includes a screening and treatment optimization phase before randomization to ensure stable Parkinsons treatment. This study may provide important insights into D-serines potential effects on Parkinsons disease progression.

Researchers are evaluating a new digital application called HeartCheck designed to support long-term follow-up care for patients who have survived an acute myocardial infarction AMI or undergone percutaneous coronary intervention PCI for stable coronary artery disease. The study aims to see if this app can help improve patients control of cardiovascular risk factors and their adherence to prescribed medications. The trial uses a randomized controlled design to compare the apps impact with usual care. Participants in the study will be randomly assigned to one of two groups one group will use the HeartCheck app, which provides education, regular reminders, and clear goals for secondary prevention of heart disease. The other group will receive standard follow-up care from their hospital and general practitioner. The study begins in April 2026 and is expected to end in December 2029. During the study, participants will be monitored for at least 12 months after joining. Researchers will track how well patients meet four evidence-based goals related to risk factor control and medication adherence. The study will collect data on participants progress and use of the app or standard care to assess the effectiveness of this digital follow-up approach in supporting heart health after AMI or PCI.

Researchers are evaluating the effects of vicadrostat combined with empagliflozin in adults who have type 2 diabetes, high blood pressure, and cardiovascular disease but no history of heart failure. The study aims to assess whether this combination can help reduce cardiovascular risks compared to a placebo with empagliflozin. This Phase III trial involves adults with these conditions who are already receiving treatment for them. Participants are randomly assigned to one of two groups. One group takes vicadrostat and empagliflozin tablets daily, while the other group takes placebo tablets that look like vicadrostat but have no active medicine, alongside empagliflozin. Treatment lasts from two and a half years up to four years and three months. All participants continue their usual medications for diabetes, blood pressure, and heart disease during the study. Throughout the study, lasting up to four years and three months, participants visit the study site regularly for health checks and blood samples. Doctors monitor cardiovascular events and any side effects experienced. The main outcome measured is the time until the first cardiovascular death or heart failure event. Other health indicators like blood pressure and kidney function are also tracked to understand the effects of the treatment combination.

Researchers are evaluating two psychological treatment approaches for young people aged 16 to 25 who experience symptoms of depression, anxiety, stress, or difficulties in relationships. This study compares group-based Acceptance and Commitment Therapy ACT with treatment as usual TAU, which is typically individual psychotherapy. The goal is to determine if the group-based ACT is as effective or more effective than standard individual therapy in helping young people with mental health challenges. The study uses a randomized controlled design to systematically compare outcomes between these two treatments. The group-based ACT intervention involves a structured program where participants meet regularly in groups of up to 10, guided by trained therapists. The therapy focuses on increasing psychological flexibility by fostering acceptance, mindfulness, values clarification, and committed action. The TAU group receives standard individual psychotherapy tailored to their clinical needs and usual care practices. Both treatments are delivered within routine clinical mental health services. Treatment sessions are manualized for ACT to ensure consistency, and the TAU treatment varies based on clinical judgment. Participants complete assessments at several points before treatment, during treatment at 6 weeks, post-treatment at 12 weeks, and follow-ups at 6 and 12 months. Evaluations include self-report questionnaires and clinician interviews measuring symptoms of depression, anxiety, psychological distress, quality of life, functioning, and psychological flexibility. Ecological momentary assessment is also used via a digital platform to track daily changes during treatment. Safety is monitored, and participants may leave the study at any time. The total participation spans up to one year to monitor long-term effects and changes.

Researchers are evaluating if patients with acute heart failure can achieve the same level of heart failure medication management through digital follow-up at home compared to traditional hospital visits, based on the STRONG-HF strategy. This study addresses the challenge of low use of recommended heart failure therapies despite evidence showing they reduce mortality, aiming to improve care delivery by testing remote medication up-titration and follow-up. The trial builds on the STRONG-HF trials success, which showed better outcomes with early medication adjustment and follow-up in specialized clinics but faced barriers due to frequent hospital visits. Participants will be randomly assigned to one of two groups one receiving follow-up and heart failure medication management at home via telecommunication led by specialized nurses, including home visits at 1, 2, 3, and 6 weeks plus a primary care physician visit around week 2 the other group receiving follow-up and medication management at hospital outpatient clinics on the same schedule. Both groups follow the STRONG-HF intensive care strategy with early and rapid medication up-titration to at least half the maximum tolerated doses at discharge and then to maximum tolerated doses after 2 weeks, with safety visits at weeks 1, 3, and 6. During the 90-day study period, participants will be monitored for medication doses, heart function via echocardiography, blood tests including NT-proBNP, quality of life assessments, self-care, and patient satisfaction. Readmissions and survival will be tracked for up to 24 months. Follow-up visits occur weekly during the first 6 weeks, and researchers will assess treatment adherence, adverse events, and healthcare costs. This approach aims to reduce the burden on patients and healthcare systems while maintaining effective heart failure care.

Researchers are studying infectious keratitis, a serious eye infection that can cause vision loss and blindness. The study aims to improve diagnosis by identifying the specific type of infectionwhether bacterial, viral, fungal, or parasiticso that treatment can be targeted more accurately. This approach hopes to reduce misdiagnosis and unnecessary treatments that may worsen vision over time. The study uses advanced, non-invasive diagnostic methods including in vivo confocal microscopy IVCM to observe the cornea cells and identify microbes in real-time. Tear film samples will also be collected to analyze molecular signals and cytokine patterns associated with different infections. These diagnostic tools are being evaluated to see if they can better match clinical outcomes and potentially lead to faster, more precise care. Participants suspected of having infectious keratitis will undergo eye examinations with IVCM and provide tear samples for analysis. Researchers will measure the specificity of IVCM findings and cytokine profiles for different microbial infections over an 18-month period. This observational study does not involve treatment interventions but focuses on diagnosis, with follow-up assessments to monitor disease progression and response over time.

Researchers are studying children and adolescents aged 2.5 to 18 years with Fetal Alcohol Spectrum Disorders FASD to explore the benefits of a standardized intervention program for parents and professionals. This program aims to improve understanding of neurodevelopmental disabilities, reduce behavioral problems, and enhance self-regulation in affected children by providing psychoeducation and parent training. The study focuses on how better parental knowledge and skills can support children with FASD and improve their outcomes. The intervention consists of an eight-session program lasting about two months, including six interactive digital psychoeducational sessions. Topics covered include general information about FASD, intervention strategies for schools and kindergartens, daily living activities, coping with self-regulation deficits, executive functions, social development, social guidance, and managing challenging behavior. Families act as their own controls by comparing assessments before and after the intervention. Participants will be assessed over up to ten months using several tools, including the Childrens Global Assessment Scale CGAS and Family Empowerment Scale FES as primary outcomes. Secondary assessments include behavior inventories, social responsiveness, executive function, and parenting stress. The study collects data on family empowerment, parenting skills, child behavior, and professional knowledge to evaluate changes after the intervention. The total participation time extends through the intervention and follow-up assessments.

Researchers are investigating whether fecal occult blood testing FIT is as effective as colonoscopy for monitoring patients after removal of colorectal polyps. Colorectal cancer, the third most common cancer worldwide, often develops from benign polyps. Colonoscopy with polyp removal lowers cancer risk, but many surveillance colonoscopies find no high-risk issues, leading to unnecessary procedures that are burdensome and resource-intensive. This trial aims to see if FIT can reduce the need for colonoscopy while maintaining patient safety and surveillance quality. Participants in this randomized trial will be assigned to one of two groups standard colonoscopy surveillance or fecal blood testing. Those in the FIT group will only undergo colonoscopy if their test detects blood. This approach may reduce colonoscopy use by over 50%, lower costs, and decrease patient discomfort, complications, and overdiagnosis. The study evaluates these methods over a long term, with primary outcomes assessed 12 years after randomization. During the study, participants will be monitored for colorectal cancer incidence and mortality, advanced neoplasia occurrence, colonoscopy findings, adherence to surveillance, cost-effectiveness, adverse events, and environmental impact. Follow-up includes evaluations at 3 and 12 years, with safety checks 30 days post-colonoscopy. The trial spans up to 12 years of participation, allowing comprehensive assessment of both surveillance strategies.