NCT06107283

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2023

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

October 24, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 30, 2023

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2024

Completed
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 17, 2024

Completed
Last Updated

October 30, 2023

Status Verified

October 1, 2023

Enrollment Period

1.4 years

First QC Date

October 24, 2023

Last Update Submit

October 24, 2023

Conditions

Keywords

Depression in Old AgeBenzodiazepines drugsGeriatrics

Outcome Measures

Primary Outcomes (1)

  • The number of patients who had an increase in Benzodiazepines in the 12 weeks following discharge from hospitalization.

    12 weeks following discharge from hospitalization.

Eligibility Criteria

Age75 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • Subject having expressed opposition to participating in the study.
  • Subject having treatment with Benzodiazepine to prevent recurrence of epileptic seizures.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gériatrie - Service de Soins de Soins Médicaux et de Réadaptation - CHU de Strasbourg - France

Strasbourg, 67091, France

RECRUITING

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 24, 2023

First Posted

October 30, 2023

Study Start

March 1, 2023

Primary Completion

August 1, 2024

Study Completion

August 17, 2024

Last Updated

October 30, 2023

Record last verified: 2023-10

Locations