Blended Care for the Discontinuation of Benzodiazepine Use

Benzodiazepine Dependence Clinical Trial

— Big Bird  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03937180
• Other study ID #: S61194
• Secondary ID: KCE-17016
• Status: Completed
• Phase: N/A
• Start date: June 24, 2019
• Est. completion date: August 2, 2021

Study information

• Verified date: July 2022
• Source: KU Leuven
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 924
• Est. completion date: August 2, 2021
• Est. primary completion date: July 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Benzodiazepine Dependence
• Benzodiazepine Dependent
• Benzodiazepine Withdrawal

Intervention

Behavioral:
• Blended care
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.
• Usual care
General practitioners offering usual care 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 both available in French and Dutch.

Locations

Country	Name	City	State
Belgium	De Sutter Inge	Aalst
Belgium	Kerckvoorde Lien	Aalter	Oost-Vlaanderen
Belgium	Maenen Arjen	Alken
Belgium	Mattart Jacques	Andenne	Namen
Belgium	Janssen Marie-Eve	Ans
Belgium	Cramm Myrjam	Antwerpen
Belgium	Maus Katelijne	Antwerpen
Belgium	Mahieu Inge	Asper	Oost-Vlaanderen
Belgium	Cuelenaere Maarten	Assenede	Oost-Vlaanderen
Belgium	Debanterlé Stéphane	Barvaux
Belgium	Bourcy Gaelle	Bastogne
Belgium	Deckers Clementine B	Bastogne
Belgium	Vanderstraeten Katrien	Berchem	Kluisbergen
Belgium	Vercruysse Klaas	Berchem
Belgium	Balligand Elie	Beringen
Belgium	De Wilde Kristien	Beveren
Belgium	Maes Marc	Beverlo
Belgium	Ceulemans Steven	Beverst	Limburg
Belgium	Coolen Antoon	Beverst	Limburg
Belgium	Geskens Valérie	Beverst	Limburg
Belgium	Van De Plas Flip	Boechout
Belgium	Kang Thida	Boncelles	Luik
Belgium	Haemels Maria-Magdalena	Boortmeerbeek
Belgium	De Sadeleer Jo	Borsbeke	Oost-Vlaanderen
Belgium	Leysen Bert	Broechem	Antwerpen
Belgium	Cloetens Hanne	Brugge
Belgium	Maryssael Mia	Brugge
Belgium	Catinus Pierric	Chatelineau	Henegouwen
Belgium	Freson Micheline	Damme
Belgium	De Meulemeester Marc	Gozée
Belgium	Van Rossem Inès	Halle
Belgium	Fransis Jan	Ham	Limburg
Belgium	Compes Annick	Hannut
Belgium	Stulens Jan	Hasselt	Limburg
Belgium	Thys Eline	Hasselt	Limburg
Belgium	Vernyns Sander	Hasselt	Limburg
Belgium	(Mingneau Jannick) Bourguignon Sofie	Heers
Belgium	De Walsche Bram	Herentals
Belgium	Degrave Stijn	Herzele	Oost-Vlaanderen
Belgium	Asselman Valerie	Hoboken	Antwerpen
Belgium	Deleu Gabriel	Hodeige	Luik
Belgium	Van Immerseel Ilke	Hove
Belgium	De Vlieghere Marieke	Jabbeke	West-Vlaanderen
Belgium	Thomas Pol	Jette	Brussel
Belgium	De Muynck Kim	Kaprijke	Oost-Vlaanderen
Belgium	Lemlijn Nathalie	Kessel-Lo	Vlaams-Brabant
Belgium	Caenepeel Laurens	Koksijde	West-Vlaanderen
Belgium	Devolder Tyrone	Kortrijk
Belgium	Maertens Katrien	Kortrijk
Belgium	Vanderbauwhede Stefanie	Kortrijk
Belgium	Staelens Toon	Lauwe
Belgium	Van Der Auwera Jolien	Lauwe
Belgium	Van Marcke Maarten	Lebbeke	Oost-Vlaanderen
Belgium	Germay Arlette	Libin	Luxemburg
Belgium	Gueibe France	Libin	Luxemburg
Belgium	Andre Jean-François	Liège	Luik
Belgium	Lambert Fabienne	Liège
Belgium	Marganne Anneline	Liège
Belgium	Rousseau Cecile	Liège	Luik
Belgium	Heijmans Stephane	Linkebeek	Vlaams-Brabant
Belgium	Maury Olivier	Linkebeek
Belgium	Delvaux Nicolas	Lissewege	West-Vlaanderen
Belgium	Knockaert Iris	Lissewege	West-Vlaanderen
Belgium	Beenders Wim	Maaseik	Limburg
Belgium	Saintmar Hélène	Marche-en-Famenne
Belgium	Moeremans Paul	Mechelen
Belgium	Van Tongelen Sofie	Mechelen	Antwerpen
Belgium	Heyvaert Goedele	Merchtem
Belgium	Muylaert Peter	Merelbeke
Belgium	Peetermans Luc	Mol
Belgium	Wuyts Tinne	Mol
Belgium	Pierard Virginie	Monceau-sur-Sambre
Belgium	Grosjean Joël	Mont-sur-Marchienne
Belgium	Demeyere Tijs	Moorslede	West-Vlaanderen
Belgium	Andries Laura	Mortsel
Belgium	Lafontaine Jean Baptiste	Namur	Namen
Belgium	Steyaert Elodie	Neupré	Luik
Belgium	Everaert Leen	Nevele	Oost-Vlaanderen
Belgium	Joos Ellen	Nevele	Oost-Vlaanderen
Belgium	Pening Maud	Nivelles	Waals-Brabant
Belgium	Lens Marie	Ottignies	Waals-Brabant
Belgium	De Groote Jaron	Oudenaarde
Belgium	Debry Jean-Yves	Ougree	Luik
Belgium	Steeno Pieter	Putte
Belgium	Lemiengre Marieke	Roeselare
Belgium	Maquet Elisabeth	Saint-Gilles	Brussel
Belgium	De Vleeschouwer Oriane	Saint-Hubert	Luxemburg
Belgium	Vanschepdael Céline	Saint-Hubert	Luxemburg
Belgium	Cardon Philippe	Sambreville
Belgium	Fauquert Benjamin	Schaerbeek	Brussel
Belgium	Vandenameele Steffi	Sijsele	West-Vlaanderen
Belgium	Vermeulen Sofie	Sint-Martens-Latem	Oost-Vlaanderen
Belgium	Meuris Michel	Spa
Belgium	De Neef Sara	Tienen
Belgium	Evrard Antoine	Tilff	Luik
Belgium	Parada Alberto	Trois-Ponts	Luik
Belgium	Op De Beeck Sabine	Turnhout
Belgium	Uhry Franck	Uccle	Brussel
Belgium	Vansintejan Johan	Vilvoorde	Brussel
Belgium	Cohnen Ingrid	Waimes	Luik
Belgium	Froidcoeur Xavier	Wanze
Belgium	Tilquin Marlene	Wanze
Belgium	Janssen Reinhilde	Watervliet
Belgium	Massaux Godelieve	Wavre	Waals-Brabant
Belgium	Bayens Kris	Weelde
Belgium	Klaasen Geert	Weelde
Belgium	Bedoret Virginie	Woluwe St Pierre	Brussel
Belgium	Vanleeuw Ben	Zolder	Limburg
Belgium	Hertegonne Nele	Zottegem
Belgium	Heyerick Maaike	Zulte	Oost-Vlaanderen

Sponsors (7)

Lead Sponsor	Collaborator
Kristien Coteur	Belgium Health Care Knowledge Centre, Université de Liège, Université Libre de Bruxelles, Universiteit Antwerpen, University Ghent, Vrije Universiteit Brussel

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients that discontinued (z-)BZD use at 12 months assessed by toxicological screening	Long-term effect of a blended care approach versus usual care on the discontinuation of (z-)BZD	12 months
Secondary	Proportion of patients that discontinued (z-)BZD use at 6 months assessed by toxicological screening	Short-term effect of a blended care approach versus usual care on the discontinuation of (z-)BZD	6 months
Secondary	EQ-5D-3L assessed at week 6, 12, 26 and 52	Effect of a blended care approach versus usual care on the quality of life. The EQ-5D-3L is the three-level version of the EuroQol five dimension scale measuring quality of life.	12 months
Secondary	Proportion of patients with self-reported discontinuation of (z-)BZD use assessed at week 6, 12, 26 and 52	Effect of a blended care approach versus usual care on self-reported discontinuation of (z-)BZD use	12 months
Secondary	The number of defined daily doses (DDD) of (z-)BZD prescribed in the preceding interval assessed at week 6, 12, 26 and 52	Effect of a blended care approach versus usual care on the number of DDD of benzodiazepines prescribed	12 months