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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03937180
Other study ID # S61194
Secondary ID KCE-17016
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


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
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