Clinical trial NCT03937180: Blended Care for the Discontinuation of Benzodiazepine Use
Official title: The Effectiveness of a Blended Care Program for the Discontinuation of Benzodiazepines Use for Sleeping Problems in Primary Care: a Clustered Randomized Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Benzodiazepine Dependence
Benzodiazepine Dependent
Benzodiazepine Withdrawal
Keywords: benzodiazepines
blended care
Lead sponsor: KU Leuven
Sponsor class: OTHER
Collaborators: name: Belgium Health Care Knowledge Centre
name: Universiteit Antwerpen
name: University Ghent
name: Vrije Universiteit Brussel
name: Université Libre de Bruxelles
name: Université de Liège
First posted: 2019-05-03
Enrollment: 924
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: cluster randomized controlled trial
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Patients aged 18 and older capable of giving informed consent,
* Having his/her Global Medical File managed by one of the participating general practitioners
* Receiving prescriptions of (z-)BZDs from participating GP for use on a daily basis
* Reporting daily intake (≥ 80% of days) of (z-)BZDs in the last 6 months for a primary indication of sleeping problems

Exclusion Criteria:

* Presence of any severe psychiatric and neurologic condition that in the judgment of the treating GP implies a contraindication for (z-)BZD withdrawal
* Presence of terminal illness
* Any cases where stopping of (z-)BZDs might be harmful
* Unwillingness or inability to provide informed consent
* Not having e-literacy (being familiar with email and internet use)
* Patients with a substance use disorder (other than (z-)BZD) will also be excluded from the study because in these cases there is often a sub-therapeutic (z-)BZD dependence and/or comorbid psychological/psychiatric comorbid conditions requiring specialist care.

Primary outcomes:
measure: Proportion of patients that discontinued (z-)BZD use at 12 months assessed by toxicological screening
timeFrame: 12 months
Secondary outcomes:
measure: Proportion of patients that discontinued (z-)BZD use at 6 months assessed by toxicological screening
timeFrame: 6 months
measure: EQ-5D-3L assessed at week 6, 12, 26 and 52
timeFrame: 12 months
measure: Proportion of patients with self-reported discontinuation of (z-)BZD use assessed at week 6, 12, 26 and 52
timeFrame: 12 months
measure: The number of defined daily doses (DDD) of (z-)BZD prescribed in the preceding interval assessed at week 6, 12, 26 and 52
timeFrame: 12 months
Other outcomes:
Locations:
city: Broechem
country: Belgium
facility: Leysen Bert
state: Antwerpen
city: Hoboken
country: Belgium
facility: Asselman Valerie
state: Antwerpen
city: Mechelen
country: Belgium
facility: Van Tongelen Sofie
state: Antwerpen
city: Jette
country: Belgium
facility: Thomas Pol
state: Brussel
city: Saint-Gilles
country: Belgium
facility: Maquet Elisabeth
state: Brussel
city: Schaerbeek
country: Belgium
facility: Fauquert Benjamin
state: Brussel
city: Uccle
country: Belgium
facility: Uhry Franck
state: Brussel
city: Vilvoorde
country: Belgium
facility: Vansintejan Johan
state: Brussel
city: Woluwe St Pierre
country: Belgium
facility: Bedoret Virginie
state: Brussel
city: Chatelineau
country: Belgium
facility: Catinus Pierric
state: Henegouwen
city: Berchem
country: Belgium
facility: Vanderstraeten Katrien
state: Kluisbergen
city: Beverst
country: Belgium
facility: Ceulemans Steven
state: Limburg
city: Beverst
country: Belgium
facility: Coolen Antoon
state: Limburg
city: Beverst
country: Belgium
facility: Geskens Valérie
state: Limburg
city: Ham
country: Belgium
facility: Fransis Jan
state: Limburg
city: Hasselt
country: Belgium
facility: Stulens Jan
state: Limburg
city: Hasselt
country: Belgium
facility: Thys Eline
state: Limburg
city: Hasselt
country: Belgium
facility: Vernyns Sander
state: Limburg
city: Maaseik
country: Belgium
facility: Beenders Wim
state: Limburg
city: Zolder
country: Belgium
facility: Vanleeuw Ben
state: Limburg
city: Boncelles
country: Belgium
facility: Kang Thida
state: Luik
city: Hodeige
country: Belgium
facility: Deleu Gabriel
state: Luik
city: Liège
country: Belgium
facility: Andre Jean-François
state: Luik
city: Liège
country: Belgium
facility: Rousseau Cecile
state: Luik
city: Neupré
country: Belgium
facility: Steyaert Elodie
state: Luik
city: Ougree
country: Belgium
facility: Debry Jean-Yves
state: Luik
city: Tilff
country: Belgium
facility: Evrard Antoine
state: Luik
city: Trois-Ponts
country: Belgium
facility: Parada Alberto
state: Luik
city: Waimes
country: Belgium
facility: Cohnen Ingrid
state: Luik
city: Libin
country: Belgium
facility: Germay Arlette
state: Luxemburg
city: Libin
country: Belgium
facility: Gueibe France
state: Luxemburg
city: Saint-Hubert
country: Belgium
facility: De Vleeschouwer Oriane
state: Luxemburg
city: Saint-Hubert
country: Belgium
facility: Vanschepdael Céline
state: Luxemburg
city: Andenne
country: Belgium
facility: Mattart Jacques
state: Namen
city: Namur
country: Belgium
facility: Lafontaine Jean Baptiste
state: Namen
city: Aalter
country: Belgium
facility: Kerckvoorde Lien
state: Oost-Vlaanderen
city: Asper
country: Belgium
facility: Mahieu Inge
state: Oost-Vlaanderen
city: Assenede
country: Belgium
facility: Cuelenaere Maarten
state: Oost-Vlaanderen
city: Borsbeke
country: Belgium
facility: De Sadeleer Jo
state: Oost-Vlaanderen
city: Herzele
country: Belgium
facility: Degrave Stijn
state: Oost-Vlaanderen
city: Kaprijke
country: Belgium
facility: De Muynck Kim
state: Oost-Vlaanderen
city: Lebbeke
country: Belgium
facility: Van Marcke Maarten
state: Oost-Vlaanderen
city: Nevele
country: Belgium
facility: Joos Ellen
state: Oost-Vlaanderen
city: Nevele
country: Belgium
facility: Everaert Leen
state: Oost-Vlaanderen
city: Sint-Martens-Latem
country: Belgium
facility: Vermeulen Sofie
state: Oost-Vlaanderen
city: Zulte
country: Belgium
facility: Heyerick Maaike
state: Oost-Vlaanderen
city: Kessel-Lo
country: Belgium
facility: Lemlijn Nathalie
state: Vlaams-Brabant
city: Linkebeek
country: Belgium
facility: Heijmans Stephane
state: Vlaams-Brabant
city: Nivelles
country: Belgium
facility: Pening Maud
state: Waals-Brabant
city: Ottignies
country: Belgium
facility: Lens Marie
state: Waals-Brabant
city: Wavre
country: Belgium
facility: Massaux Godelieve
state: Waals-Brabant
city: Jabbeke
country: Belgium
facility: De Vlieghere Marieke
state: West-Vlaanderen
city: Koksijde
country: Belgium
facility: Caenepeel Laurens
state: West-Vlaanderen
city: Lissewege
country: Belgium
facility: Delvaux Nicolas
state: West-Vlaanderen
city: Lissewege
country: Belgium
facility: Knockaert Iris
state: West-Vlaanderen
city: Moorslede
country: Belgium
facility: Demeyere Tijs
state: West-Vlaanderen
city: Sijsele
country: Belgium
facility: Vandenameele Steffi
state: West-Vlaanderen
city: Aalst
country: Belgium
facility: De Sutter Inge
city: Alken
country: Belgium
facility: Maenen Arjen
city: Ans
country: Belgium
facility: Janssen Marie-Eve
city: Antwerpen
country: Belgium
facility: Cramm Myrjam
city: Antwerpen
country: Belgium
facility: Maus Katelijne
city: Barvaux
country: Belgium
facility: Debanterlé Stéphane
city: Bastogne
country: Belgium
facility: Bourcy Gaelle
city: Bastogne
country: Belgium
facility: Deckers Clementine B
city: Berchem
country: Belgium
facility: Vercruysse Klaas
city: Beringen
country: Belgium
facility: Balligand Elie
city: Beveren
country: Belgium
facility: De Wilde Kristien
city: Beverlo
country: Belgium
facility: Maes Marc
city: Boechout
country: Belgium
facility: Van De Plas Flip
city: Boortmeerbeek
country: Belgium
facility: Haemels Maria-Magdalena
city: Brugge
country: Belgium
facility: Cloetens Hanne
city: Brugge
country: Belgium
facility: Maryssael Mia
city: Damme
country: Belgium
facility: Freson Micheline
city: Gozée
country: Belgium
facility: De Meulemeester Marc
city: Halle
country: Belgium
facility: Van Rossem Inès
city: Hannut
country: Belgium
facility: Compes Annick
city: Heers
country: Belgium
facility: (Mingneau Jannick) Bourguignon Sofie
city: Herentals
country: Belgium
facility: De Walsche Bram
city: Hove
country: Belgium
facility: Van Immerseel Ilke
city: Kortrijk
country: Belgium
facility: Devolder Tyrone
city: Kortrijk
country: Belgium
facility: Maertens Katrien
city: Kortrijk
country: Belgium
facility: Vanderbauwhede Stefanie
city: Lauwe
country: Belgium
facility: Staelens Toon
city: Lauwe
country: Belgium
facility: Van Der Auwera Jolien
city: Linkebeek
country: Belgium
facility: Maury Olivier
city: Liège
country: Belgium
facility: Marganne Anneline
city: Liège
country: Belgium
facility: Lambert Fabienne
city: Marche-en-Famenne
country: Belgium
facility: Saintmar Hélène
city: Mechelen
country: Belgium
facility: Moeremans Paul
city: Merchtem
country: Belgium
facility: Heyvaert Goedele
city: Merelbeke
country: Belgium
facility: Muylaert Peter
city: Mol
country: Belgium
facility: Peetermans Luc
city: Mol
country: Belgium
facility: Wuyts Tinne
city: Monceau-sur-Sambre
country: Belgium
facility: Pierard Virginie
city: Mont-sur-Marchienne
country: Belgium
facility: Grosjean Joël
city: Mortsel
country: Belgium
facility: Andries Laura
city: Oudenaarde
country: Belgium
facility: De Groote Jaron
city: Putte
country: Belgium
facility: Steeno Pieter
city: Roeselare
country: Belgium
facility: Lemiengre Marieke
city: Sambreville
country: Belgium
facility: Cardon Philippe
city: Spa
country: Belgium
facility: Meuris Michel
city: Tienen
country: Belgium
facility: De Neef Sara
city: Turnhout
country: Belgium
facility: Op De Beeck Sabine
city: Wanze
country: Belgium
facility: Froidcoeur Xavier
city: Wanze
country: Belgium
facility: Tilquin Marlene
city: Watervliet
country: Belgium
facility: Janssen Reinhilde
city: Weelde
country: Belgium
facility: Bayens Kris
city: Weelde
country: Belgium
facility: Klaasen Geert
city: Zottegem
country: Belgium
facility: Hertegonne Nele
Study officials:
affiliation: KU Leuven
name: Catharina Matheï
role: STUDY_CHAIR
References:
citation: Coteur K, Van Nuland M, Vanmeerbeek M, Henrard G, Anthierens S, Van den Broeck K, De Sutter A, Creupelandt H, Devroey D, Van Overmeire R, Offermans AM, Kacenelenbogen N, Laenen A, Mathei C. 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. BMJ Open. 2020 Feb 18;10(2):e033688. doi: 10.1136/bmjopen-2019-033688.