Bailleul

Researchers are evaluating the safety of the SECURIDRAP4 SELFIA4 bedding system in adults with disorientation, cognitive impairment, or behavior disorders. This interventional, multicenter, prospective, and non-comparative clinical investigation takes place in nursing homes and hospitals in France. It was initiated following the market withdrawal of the first version of the product and is conducted to confirm the safety of the second version as recommended by the ASNM. Participants will use the SECURIDRAP4 SELFIA4 restraint system for 15 consecutive nights as part of their usual care. An independent assessor will monitor the proper use of the bedding system during this period to ensure compliance with safety conditions. The study focuses on adverse events linked to the product, user errors, patient bedridden status, healthcare team satisfaction, and the learning curve for proper use. During the 15-night follow-up, patients will be closely observed, and data on adverse events and user-related safety issues will be collected. Healthcare teams will provide feedback on time savings, comfort, well-being, and respect for patient dignity. The study tracks the rate of patients remaining bedridden each night and monitors the staffs ability to learn the proper use of the SECURIDRAP4 SELFIA4 system. The total participation duration is 15 nights with minimal risks and constraints.

People with mental disorders tend to smoke more than the general population, which contributes to a significant reduction in their life expectancy by 10 to 20 years, mainly due to heart and lung diseases such as bronchial cancers. Despite this, smoking cessation efforts tailored for psychiatric patients are limited, as smoking is often overlooked or accepted in mental health care settings. This study aims to assess a smoking cessation program called Tabapsy designed with input from mental health users, professionals, and general practitioners, focusing on adult patients receiving outpatient psychiatric care. The Tabapsy intervention includes a campaign promoting smoking cessation within psychiatric medical psychological centers CMPs and a series of supportive activities. These activities involve an initial information meeting to boost motivation, an assessment workshop to evaluate nicotine dependence and create personalized quitting plans, five thematic workshops covering nicotine replacement, emotional management, weight control, physical activity, and manual tasks, and peer support groups for shared experiences. A dedicated facilitator will lead these sessions, supported by an online resource website. The study compares the intervention against usual care in a national cluster-randomized trial involving psychiatric sectors. Participants who smoke regularly and consent will complete questionnaires via a web app at the start, 3 months, and 6 months, with additional surveys for those in the intervention group. The questionnaires cover smoking habits, dependence, motivation, cessation aid use, mental and physical well-being, and knowledge about tobacco. The main outcome is smoking cessation lasting at least 7 days at 3 months. Secondary outcomes include cost-effectiveness, implementation, quit attempts, and satisfaction. A total of 6,250 participants will be enrolled over 12 months across 22 sectors.