Improving Patient Safety by Supporting Older Adults in Managing Sleep Problems.
Condition(s) studied
Investigational drug(s) / intervention(s)
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.
Study 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.
Eligibility
Primary outcome measure(s)
- BSH discontinuation — 12 months after enrollment
Number of patients with BSH discontinuation according to self-/informal carer-disclosure. Discontinuation is defined as the intake of a maximum of one tablet within the previous 14 days. - Quality of sleep — 12 months after enrollment
Quality of sleep measured by the Insomnia Severity Index (ISI). The questionnaire consists of 7 questions, answers range from 0-4 points, which are added up to get a total score. The higher the total score, the more severe level of insomnia.
Trial sites (6)
| Facility | City | Region | Status |
|---|---|---|---|
| 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 |
More Insel Gruppe AG, University Hospital Bern trials in Spain
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06584513 on ClinicalTrials.gov ↗ ← All trials in Spain