Study of the Reduction of the Prescriptions of Benzodiazepines and Related (BZD)

October 24, 2023 updated by: University Hospital, Strasbourg, France

Study of the Reduction of the Prescriptions of Benzodiazepines and Related After the Discharge of a Service of Follow-up Care and Geriatric Rehabilitation

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.

Study Overview

Status

Recruiting

Conditions

Detailed 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.

Study Type

Observational

Enrollment (Estimated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Strasbourg, France, 67091
        • Recruiting
        • Gériatrie - Service de Soins de Soins Médicaux et de Réadaptation - CHU de Strasbourg - France
        • Contact:
        • Principal Investigator:
          • Alexandre BOUSSUGE, MD
        • Contact:
        • Principal Investigator:
          • Pierre WURTZ, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Major subject (≥ 75 years old) 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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The number of patients who had an increase in Benzodiazepines in the 12 weeks following discharge from hospitalization.
Time Frame: 12 weeks following discharge from hospitalization.
12 weeks following discharge from hospitalization.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Strasbourg, France

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2023

Primary Completion (Estimated)

August 1, 2024

Study Completion (Estimated)

August 17, 2024

Study Registration Dates

First Submitted

October 24, 2023

First Submitted That Met QC Criteria

October 24, 2023

First Posted (Actual)

October 30, 2023

Study Record Updates

Last Update Posted (Actual)

October 30, 2023

Last Update Submitted That Met QC Criteria

October 24, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 8787

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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