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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06107283
Other study ID # 8787
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date March 1, 2023
Est. completion date August 17, 2024

Study information

Verified date October 2023
Source University Hospital, Strasbourg, France
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The significant consumption of Benzodiazepines and related drugs in the elderly outside of good practice recommendations is a major issue in the care of the elderly. Adverse effects have been the subject of numerous studies, leading to falls, addictions and even deaths. The general practitioner is often faced with long-term medication intake which is not consistent with a good benefit/risk balance, but stopping or reducing the dosage remains a problem in current practice. The Aftercare and Geriatric Rehabilitation services due to their operation (several weeks of hospitalization) seek to adapt the patient's therapies in order to obtain the most convincing benefit/risk balance possible. A reduction or withdrawal of treatments with Benzodiazepines or related drugs are therefore frequently initiated.


Description:

The aim of this research is to quantify among the patients who benefited from a dosage reduction of Benzodiazepines and related drugs during a stay in the Geriatric Care and Aftercare and Rehabilitation department, the number of patients who had an increase of this treatment within 12 weeks following discharge from hospitalization.


Recruitment information / eligibility

Status Recruiting
Enrollment 150
Est. completion date August 17, 2024
Est. primary completion date August 2024
Accepts healthy volunteers No
Gender All
Age group 75 Years and older
Eligibility Inclusion Criteria: - Major subject (= 75 years old) - Subject discharged from a geriatric Follow-up Care and Rehabilitation service for whom a reduction in the dosage of Benzodiazepines and related drugs was carried out during hospitalization and who returned home (individual or EHPAD) after hospitalization. - Subject not opposing, after information, the reuse of their data for the purposes of this research. Exclusion Criteria: - Subject having expressed opposition to participating in the study. - Subject having treatment with Benzodiazepine to prevent recurrence of epileptic seizures.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
France Gériatrie - Service de Soins de Soins Médicaux et de Réadaptation - CHU de Strasbourg - France Strasbourg

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary The number of patients who had an increase in Benzodiazepines in the 12 weeks following discharge from hospitalization. 12 weeks following discharge from hospitalization.
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