NCT03937180: Big Bird

Blended Care for the Discontinuation of Benzodiazepine Use

Completed NA Last updated 15 July 2022

What this trial tests

NA trial testing Blended care in Benzodiazepine Dependence in 924 participants. Completed in 2 August 2021.

Timeline

24 June 2019

Primary endpoint
30 July 2021

2 August 2021

Quick facts

Lead sponsor	Kristien Coteur
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	924
Start date	24 June 2019
Primary completion	30 July 2021
Estimated completion	2 August 2021
Sites	110 locations across Belgium

Drugs / interventions tested

• Blended care
• Usual care

Conditions studied

• Benzodiazepine Dependence — all drugs for Benzodiazepine Dependence →
• Benzodiazepine Dependent — all drugs for Benzodiazepine Dependent →
• Benzodiazepine Withdrawal — all drugs for Benzodiazepine Withdrawal →

Sponsor

Kristien Coteur

Who can join

18 and older, any sex, with Benzodiazepine Dependence or Benzodiazepine Dependent. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study aims to compare two strategies performed by GPs to help patients taking benzodiazepines on a daily basis for at least six months to discontinue their use. The first strategy consists of the usual or standard support provided by the GP, which often starts with a discontinuation advice or letter, the second is blended support where face-to-face consultations with the GP are alternated with web-based self-learning by the patient.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Blended care to discontinue benzodiazepine receptor agonists use in patients with chronic insomnia disorder: a pragmatic cluster randomized controlled trial in primary care.
   Coteur K, Henrard G, Schoenmakers B, Laenen A, et al · · 2023 · cited 13× · PMID 36413221 · DOI 10.1093/sleep/zsac278
2. Effectiveness of a blended care programme for the discontinuation of benzodiazepine use for sleeping problems in primary care: study protocol of a cluster randomised trial, the Big Bird trial.
   Coteur K, Van Nuland M, Vanmeerbeek M, Henrard G, et al · · 2020 · cited 6× · PMID 32075832 · DOI 10.1136/bmjopen-2019-033688
3. Implementing Blended Care to Discontinue Benzodiazepine Receptor Agonist Use for Insomnia: Process Evaluation of a Pragmatic Cluster Randomized Controlled Trial.
   Coteur K, Van Nuland M, Schoenmakers B, Anthierens S, et al · · 2023 · cited 5× · PMID 37027198 · DOI 10.2196/43738
4. Fostering clinical research in general practice and family medicine. Selected abstracts from the 93rd EGPRN conference Halle, Germany, 14–17 October 2021 : All abstracts of the conference can be found at the EGPRN website https://www.egprn.org/page/conference-abstracts
   · 2023