Effectiveness of a Community Intervention in the Chronic Use of Benzodiazepines: (BENZOSTOPJUNTOS)

Not Applicable

Completed

• Conditions: Inappropriate Prescribing
• Interventions: Behavioral: Intervention for reducing benzodiazepines long-term use.

• Registration Number: NCT06209827
• Lead Sponsor: Andalusian Health Service

Brief Summary

This study aimed to assess the effectiveness of a comprehensive, multicomponent intervention utilizing education and support for Benzodiazepines withdrawal compared to standard care.

Detailed Description

The excessive use of benzodiazepines (BZDs) presents significant health concerns and high healthcare costs, particularly in Spain, where usage rates are among the highest globally. In Andalusian, over a 10% of the population use BZDs long-term, prompting the need for safe and effective reduction strategies.

This study aimed to assess the effectiveness of a comprehensive, multicomponent intervention utilizing education and support for BZD withdrawal compared to standard care.

The intervention involved educational discussions, consultations with health professionals, and letters supported by multiple scientific societies.

Study Timeline

• Study Start: 2018-01-01
• Primary Completion: 2021-12-31
• Study Completion: 2021-12-31
• Status Verified: 2024-01
• Study First Submitted: 2024-01-06
• Study First Submitted QC: 2024-01-16
• Study First Posted: 2024-01-18
• Last Update Submitted: 2024-01-31
• Last Update Posted: 2024-02-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 472

Inclusion Criteria

• users of health centre's with more than 4 weeks of benzodiazepines use.
• users of health centre's over 18 years of age.

Exclusion Criteria

• users of health centre's with mental disorder.
• users of health centre's terminal.
• users of health centre's with alcohol dependence.
• users of health centre's with dementia.
• users of health centre's who had intellectual disabilities.
• users of health centre's unable to cooperate with the questionnaires.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention for reducing benzodiazepines long-term use.	Intervention for reducing benzodiazepines long-term use.	It included the multiple components as follows: (i) an exchange discussion with the patient describing the advantages, disadvantages and alternatives of benzodiazepines use and a tapering protocol with the support of educational material, (ii) the offer of a brief, if necessary, consultation with the family doctor, and (iii) a letter addressed to the patient supported by scientific societies.

Primary Outcome Measures

Name	Time	Method
Number of dispensing of benzodiazepines.	3.5 years	Number of dispensing of benzodiazepines, measured at the level of the participant.

Secondary Outcome Measures

Name	Time	Method
Knowledge	6 months	Knowledge: Empower questionary, measured at the level of the participant.
Life Quality	6 months	Quality of life:Functional Status Measurement Sheets by coop World Organisation of Family Doctors (COOP/ WONCA): The six COOP-WONCA Charts are described by vignettes and measured at the level of the participant: physical fitness, feelings, daily activities, social activities, change in health and overall health.; WONCA: World Organisation of Family Doctors

Trial Locations

Locations (1)

Ingrid Ferrer López; 🇪🇸 Sevilla, Spain