RecruitingNot ApplicableNCT06584513

Improving Patient Safety by Supporting Older Adults in Managing Sleep Problems.

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)


Sponsor

Insel Gruppe AG, University Hospital Bern

Enrollment

470 participants

Start Date

Nov 18, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying Specific tapering plan for sleep medication, educational and cognitive behavioural therapy elements for people with benzodiazepines deprescribing and sleep problems. The study is currently recruiting participants at 6 locations. People eligible for this study include aged 65 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERSpecific 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

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NCT06584513


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