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Found 3 Actively Recruiting clinical trials
Actively Recruiting
Researchers are evaluating a structured multidisciplinary approach called iABC to improve the management of elderly patients with atrial fibrillation AF who have multiple long-term health conditions. This study aims to compare the iABC approach with usual clinical care to see if it leads to better clinical outcomes and quality of life. The iABC strategy focuses on three key areas preventing stroke with appropriate anticoagulation, improving symptom control, and optimizing treatment of related heart and other health conditions. The trial is conducted across several European countries including Bulgaria, Denmark, Italy, Romania, Serbia, and Spain. The study is designed as a cluster randomized trial where participating centers are assigned either to implement the iABC platform or continue their usual care practices. The iABC platform combines an educational program, a healthy diet and physical activity plan, guideline-based medication management, and regular patient reassessments. Doctors using iABC can monitor patient data and provide personalized advice on treatments and lifestyle throughout the study. Centers in the control group will manage patients according to their local standard care guidelines. Participants will be followed for at least 12 months to assess the impact of iABC on outcomes such as unplanned hospitalizations, stroke and cardiovascular events, physical activity levels, patient engagement, and medication adherence. The study includes regular data collection to monitor these factors and assess adherence to the iABC care pathway. This approach aims to provide clear evidence about whether a holistic, integrated care model can improve health and quality of life in older adults with AF and multiple health issues.
Actively Recruiting
Healthy Volunteer
Researchers are evaluating Projecte Benestar, an immersive virtual reality educational program designed to support emotional well-being, self-care, mindfulness, emotional regulation, and self-compassion among healthcare workers. This multicenter randomized controlled trial focuses on reducing emotional exhaustion in healthcare professionals, measured by the Maslach Burnout Inventory. The study includes active clinical and non-clinical staff from various healthcare settings who voluntarily agree to participate. Participants are randomly assigned to two groups. One group receives the virtual reality program immediately, consisting of eight individual sessions delivered through autonomous headsets. Each session lasts 9 to 15 minutes and covers mindfulness, breathing exercises, body scan, emotional regulation, the RAIN technique, self-compassion, and integration. Sessions may be spread over 8 weeks with one session per week or an intensive 4-week schedule with two sessions weekly. The other group continues usual activities for about 6 months before receiving the same program, allowing comparison between immediate and delayed intervention. Participants complete sessions seated in a quiet institutional space with technical support available if needed. Data collection includes baseline, after the first intervention, at 6 months, after delayed intervention, and at 12 months, assessing emotional exhaustion, depersonalization, personal accomplishment, work engagement, usability, satisfaction, adherence, and tolerability. The main outcome is the change in emotional exhaustion scores, with follow-up over time to monitor progress and safety. Total study duration extends up to 12 months per participant.
Actively Recruiting
Healthy Volunteer
This research aims to evaluate the preventive effect of placing an onlay mesh compared to using a standard fascial closure device at the umbilical trocar site to prevent incisional hernia after laparoscopic surgery. The study focuses on adult patients undergoing elective laparoscopic cholecystectomy, with or without exploration of the common bile duct. The trial is a two-center randomized controlled study designed to address the high prevalence of incisional hernia after laparoscopy, which can be as high as 30%, and to improve closure techniques using imaging methods for accurate diagnosis. Participants will be randomly assigned to one of two groups. In the prosthesis group, after suturing the aponeurosis, a lightweight, large-pore mesh made of PVDF monofilament will be placed onlay over the incision and fixed with cyanoacrylate glue. In the control group, the aponeurosis will be closed using the standard suturing technique without mesh. Both procedures take place after the laparoscopic cholecystectomy is performed. Follow-up includes an abdominal ultrasound scan focused on aponeurosis defects at the trocar sites at 12 months post-surgery to detect hernia occurrence. During the study, adverse events will be monitored and classified according to the Clavien Dindo classification. Participants will be assessed with ultrasound imaging at 12 months to reduce underdiagnosis of incisional hernia. Data analysis will include statistical comparisons between groups to evaluate the effectiveness of the mesh in preventing hernias. The minimum follow-up period is 12 months, and economic impact and perioperative complications within 30 days will also be reviewed.