Clinical Research Directory
Browse clinical research sites, groups, and studies.
Improving Patient Safety by Supporting Older Adults in Managing Sleep Problems.
Sponsor: Insel Gruppe AG, University Hospital Bern
Summary
Among older adults (≥65 years), use of sleeping pills, such as benzodiazepines and other sedative-hypnotics, to treat sleep problems is common. While sleeping pills are effective in the first few weeks of use, their effect diminishes significantly after that. Especially older adults are susceptible to significant adverse effects of sleep pills, yet stopping sleeping pills remains challenging. BE-SAFE aims to conduct a randomised study testing a patient-centred intervention to reduce sleeping pill use and to improve patient safety and quality of care focusing on implementation aspects. The intervention addresses knowledge and practice gaps related to discontinuation of sleeping pills in older adults with sleep problems.
Official title: Implementing a Patient-centred and Evidence-based Intervention to Reduce BEnzodiazepine and Sedative-hypnotic Use to Improve Patient SAFEty and Quality of Care (BE-SAFE)
Key Details
Gender
All
Age Range
65 Years - Any
Study Type
INTERVENTIONAL
Enrollment
470
Start Date
2024-11-18
Completion Date
2026-02-01
Last Updated
2025-09-30
Healthy Volunteers
No
Interventions
Specific tapering plan for sleep medication, educational and cognitive behavioural therapy elements
The intervention consists of a patient-centred intervention to help patients in deprescribing BSHs and better managing their sleep problems. The material used consists of training modules, brochures, and self-monitoring tools. There are materials for physicians and for patients.
Locations (6)
Centre Hospitalier Universitaire CHU UCL Namur
Yvoir, Belgium
National and Kapodistrian University of Athens
Athens, Greece
Oslo University Hospital
Nydalen, Norway
Institute of Psychiatry and Neurology
Warsaw, Poland
Universitat Autònoma de Barcelona
Barcelona, Spain
Department of General Internal Medicine, University Hospital Bern (Inselspital)
Bern, Switzerland