KCE-17016: Effizienz eines gemischten Behandlungsprogramms zur Reduzierung der Benzodiazepin-Einnahme bei Schlafstörungen in der Primärversorgung: eine randomisierte Cluster-Studie - Big-Bird-Studie

Zusammenfassung (Niederländisch oder Französisch oder Englisch)

 

Trial Description

 

Title

The effectiveness of a blended care program for the discontinuation of benzodiazepines use for sleeping problems in primary care: a clustered randomized trial (KCE-17016)

Participants (P)

Patients in primary care with chronic benzodiazepine (BZD) use for primarily sleeping indication

Intervention (I)

An interactive e-learning programme delivered through a secured web-based platform for patients and general practitioners (GPs), blended with face-to-face contacts between the involved GP and patient. The e-tool provides psycho-education about sleep and sleeping disorders, sleeping medication and its associated risks, non-pharmacological alternatives and tapering of (z-)BZD.

Control (C)

Patients will receive ‘usual care’ left at the discretion of the treating GP. GPs are expected to follow the Belgian guidelines as described in the most recent online version of “Anxiety, stress and sleeping problems A toolbox for general practitioners.” or “Sleeping pills and sedatives. How to assist your patients in the search for other solutions?” which are available both in French and Dutch. The recommended approach proposed in this toolbox typically involves education of the patient about the harmful effects of chronic (z-)BZD use and the alternatives, and advice to discontinue (z-)BZD use.

Outcome (O)

Proportion of patients that discontinued (z-)BZD use at 12 months assessed by toxicological screening

Trial Design

Cluster randomised trial at level of GP practice

Sample Size

1182 patients

Trial duration

20 months (FPI-CSR)

Budget

€2.2 million (incl. VAT)

Start date (FPI)

Q2 2019

Status

Closed to recruitment - in follow up

Study report expected

Q1 2021

 

Trial team

Sponsor

UZ Leuven

Chief Investigator

Prof. Dr. Catharina Matheï

Academic Centre for General Practice, KU Leuven

Trial coordinator

Kristien Coteur

Participating investigators

120 GPs
Dokument
Protocol click here
Report

Q2 2021

Publication

Q3 2021

Verweise

Clinicaltrials.gov: NCT03937180

Big Bird trial webpage 

FINANZIERUNGSSCHEMA

Investigator-led workstream 2017