Informative Exhibition for Deprescribing Benzodiazepines | NCT06467019

Studies
Informative Exhibition for Deprescribing Benzodiazepines

NCT06467019

Sponsor

Consorci Sanitari de l'Alt Penedès i Garraf

Status

Recruiting

Last Update Posted

Jun 26, 2025Actual

Enrollment

6,410Estimated

Phase

Not provided

Conditions

Benzodiazepine-Related Disorders

Interventions

Informative Session

Countries

Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 13, 2024Actual

Primary Completion Date

Jul 2026Estimated

Completion Date

Jul 2026Estimated

First Submitted Date

Jun 14, 2024

First Submission Date that Met QC Criteria

Jun 14, 2024

First Posted Date

Jun 20, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 23, 2025

Last Update Posted Date

Jun 26, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

6,410Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Informative Session	Other	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Chronic treatment with benzodiazepines	Percentage of patients treated chronically with benzodiazepines, based on electronic prescription data.	1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

99 Years

Standard Ages

AdultOlder Adult

Study Population

Community population assigned to a primary care center.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Jordi Milozzi, MD	Contact	+34 938 10 30 03		jmilozzi@csapg.cat
Noemí Casaponsa	Contact	+34 938960025	43197	recerca@csapg.cat

Overall Officials

Name	Affiliation	Role
Jordi Milozzi, MD	Centro de Salud Vilanova i la Geltrú 3 Baix A Mar-CSAPG	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Centro de Salud Vilanova i la Geltrú 3 Baix A Mar	Recruiting	Vilanova i la Geltrú	Barcelona		Spain

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

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).

Types

Study Protocol
Informed Consent Form (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.

URL

Not provided