Benzodiazepine Dependence Clinical Trial
— Big BirdOfficial title:
The Effectiveness of a Blended Care Program for the Discontinuation of Benzodiazepines Use for Sleeping Problems in Primary Care: a Clustered Randomized Trial.
Verified date | July 2022 |
Source | KU Leuven |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
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 |
Lead Sponsor | Collaborator |
---|---|
Kristien Coteur | Belgium Health Care Knowledge Centre, Université de Liège, Université Libre de Bruxelles, Universiteit Antwerpen, University Ghent, Vrije Universiteit Brussel |
Belgium,
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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---|---|---|---|
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