NCT06467019

Brief Summary

The goal of this trial is to determine if an interactive and informative exhibition in the waiting room of a Primary Care Clinic can reduce the use of benzodiazepines in adults. The main question it aims to answer is: • Does an interactive and informative exhibition reduce the number of participants using benzodiazepines? Researchers will compare benzodiazepine consumption before and after the interactive and informative exhibition implementation at study center. Participants will receive an informative and interactive exhibition on the risks of chronic benzodiazepine use. A single informative session on the same topic will be conducted for health professionals.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
6,410

participants targeted

Target at P75+ for all trials

Timeline
2mo left

Started Jun 2024

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress93%
Jun 2024Jul 2026

Study Start

First participant enrolled

June 13, 2024

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

June 14, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 20, 2024

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Last Updated

June 26, 2025

Status Verified

June 1, 2025

Enrollment Period

2 years

First QC Date

June 14, 2024

Last Update Submit

June 23, 2025

Conditions

Keywords

BenzodiazepinesDeprescriptions

Outcome Measures

Primary Outcomes (1)

  • Chronic treatment with benzodiazepines

    Percentage of patients treated chronically with benzodiazepines, based on electronic prescription data.

    1 year

Study Arms (2)

Before intervention

This group will consist of patients who attended the primary care center before the implementation of the intervention.

After intervention

This group will consist of patients who will attend the primary care center after the implementation of the intervention.

Other: Informative Session

Interventions

The intervention consists of implementing an interactive exhibition on the risks of chronic benzodiazepine treatment in the waiting room of a primary care center. Additionally, the health professionals at the center will receive a single informative session on the same topic.

After intervention

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Community population assigned to a primary care center.

You may qualify if:

  • Men and women between 18 and 99 years of age.
  • Attended at the Baix-a-Mar Primary Care Center during the study period.

You may not qualify if:

  • Severe mental health disease
  • Displaced patients or those who do not have an assigned doctor at the center.
  • Participation in another study involving an experimental intervention during the period of the present study that affects benzodiazepine prescription.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centro de Salud Vilanova i la Geltrú 3 Baix A Mar

Vilanova i la Geltrú, Barcelona, Spain

RECRUITING

Study Officials

  • Jordi Milozzi, MD

    Centro de Salud Vilanova i la Geltrú 3 Baix A Mar-CSAPG

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jordi Milozzi, MD

CONTACT

Noemí Casaponsa

CONTACT

Study Design

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

Study Record Dates

First Submitted

June 14, 2024

First Posted

June 20, 2024

Study Start

June 13, 2024

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

July 1, 2026

Last Updated

June 26, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will share

IPD (without personal identification data) could be shared by requirement from other researchers after the end of the study, and only for research purposes and previous approval of promotor center of the study (CSAPG). Anyway, Spanish and European Union legal policy about data protection will strictly be followed (IPD will not be transferred outside European Union).

Shared Documents
STUDY PROTOCOL, ICF
Time Frame
After publication of main results of the study.
Access Criteria
IPD will be shared only for scientific research purposes and following the Spanish and European Union normative law about data protection. The requirements will be directed to the IP of the study. The IP will evaluate the request to verify and evaluate the data that is requested and the purposes for which it is requested. Next, the IP will transfer the request to the promotor center the study for the final decision.

Locations