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| ID | Type | Description | Link |
|---|---|---|---|
| KCE-17016 | Other Grant/Funding Number | KCE |
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| Name | Class |
|---|---|
| Belgium Health Care Knowledge Centre | OTHER_GOV |
| Universiteit Antwerpen | OTHER |
| University Ghent | OTHER |
| Vrije Universiteit Brussel |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual care | Other | Patients will receive 'usual care' left at the discretion of the treating general practitioner (GP). They are expected to follow the Belgian guidelines, which propose education of the patient about the harmful effects of chronic benzodiazepines and z-drugs ((z-)BZD) use, the alternatives, and the advice to discontinue (z-)BZD use. A stepped approach is recommended. First, a minimal intervention strategy such as a discontinuation letter or a short advice is applied. If unsuccessful, a brief intervention, which may span one or more consults, is recommended. During such an intervention, the GP will - based on the principles of motivational interviewing- assess the patient's readiness for change and match the appropriate intervention. A tapering scheme will be developed which typically consists of a 10-20% reduction in the daily dose of the (z-)BZD every 2-4 weeks. |
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| Blended care | Experimental | Usual care is supported by the use of an interactive e-tool. The e-tool provides psycho-education about sleep and sleep medication, and exercises featuring cognitive behavioural techniques to enhance the self-management of the patient. It's purpose is to motivate patients to discontinue the use of (z-)BZD, to adapt alternative remedies and to support them in this process. The patient can grant the participating GP access to all his answers in the e-tool, making it possible to discuss their findings and experiences face-to-face. During consultations, the GP will also assess the patients' readiness for change and match the appropriate intervention. A tailored gradual taper of the (z-)BZD will be agreed upon, which typically consists of a 10-20% reduction in the daily dose every 2-4 weeks. Follow-up appointments are scheduled depending on the needs of the patient until the end of dose reduction. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blended care | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| EQ-5D-3L assessed at week 6, 12, 26 and 52 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Catharina Matheï | KU Leuven | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Leysen Bert | Broechem | Antwerpen | 2520 | Belgium | ||
| Asselman Valerie |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37027198 | Derived | Coteur K, Van Nuland M, Schoenmakers B, Anthierens S, Van den Broeck K. Implementing Blended Care to Discontinue Benzodiazepine Receptor Agonist Use for Insomnia: Process Evaluation of a Pragmatic Cluster Randomized Controlled Trial. JMIR Form Res. 2023 Apr 7;7:e43738. doi: 10.2196/43738. | |
| 36413221 | Derived |
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All individual participant data (IPD) that underlie the results in our publications will be made available upon request. The IPD set will consist of deidentified participant data. It can be obtained by contacting the research team at KU Leuven: PI, catharina.mathei@kuleuven.be; trial coordinator, marc.vannuland@kuleuven.be; project manager, kristien.coteur@kuleuven.be. Each request before September 2023 will be reviewed by the Sponsor.
In addition to the IPD set, we will also make the study protocol available through an open access publication, and have registered the trial on clinicaltrials.gov (NCT03937180). The informed consent forms are also publicly available through the trial website (www.bigbirdtrial.com), where the clinical study report will also be disseminated at the end of the trial, after approval of the funder KCE.
All IPD will be available upon request, after publication of the results concerning the primary outcome, starting six months after publication. The IPD set can be requested until September 2023. For any request later than this date, follow-up by the Sponsor cannot be guaranteed.
Reuse of the IPD set is only allowed for non-profit research, with correct reference to the original research and Sponsor.
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Apr 24, 2023 | |
| Reset | Jan 23, 2024 |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 20, 2020 |
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| OTHER |
| Université Libre de Bruxelles | OTHER |
| Université de Liège | OTHER |
cluster randomized controlled trial
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| Usual care | Behavioral | 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. |
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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 |
| 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 |
| 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 |
| Hoboken |
| Antwerpen |
| 2660 |
| Belgium |
| Van Tongelen Sofie | Mechelen | Antwerpen | 2800 | Belgium |
| Thomas Pol | Jette | Brussels Capital | 1090 | Belgium |
| Maquet Elisabeth | Saint-Gilles | Brussels Capital | 1060 | Belgium |
| Fauquert Benjamin | Schaarbeek | Brussels Capital | 1030 | Belgium |
| Uhry Franck | Uccle | Brussels Capital | 1180 | Belgium |
| Vansintejan Johan | Vilvoorde | Brussels Capital | 1800 | Belgium |
| Bedoret Virginie | Woluwe-Saint-Pierre - Sint-Pieters-Woluwe | Brussels Capital | 1150 | Belgium |
| Catinus Pierric | Châtelineau | Henegouwen | 6200 | Belgium |
| Vanderstraeten Katrien | Berchem | Kluisbergen | Belgium |
| Ceulemans Steven | Beverst | Limburg | 3740 | Belgium |
| Coolen Antoon | Beverst | Limburg | 3740 | Belgium |
| Geskens Valérie | Beverst | Limburg | 3740 | Belgium |
| Fransis Jan | Ham | Limburg | 3945 | Belgium |
| Stulens Jan | Hasselt | Limburg | 3500 | Belgium |
| Thys Eline | Hasselt | Limburg | 3500 | Belgium |
| Vernyns Sander | Hasselt | Limburg | 3510 | Belgium |
| Beenders Wim | Maaseik | Limburg | 3680 | Belgium |
| Vanleeuw Ben | Zolder | Limburg | 3350 | Belgium |
| Kang Thida | Boncelles | Luik | 4100 | Belgium |
| Deleu Gabriel | Hodeige | Luik | 4351 | Belgium |
| Andre Jean-François | Liège | Luik | 4000 | Belgium |
| Rousseau Cecile | Liège | Luik | 4020 | Belgium |
| Steyaert Elodie | Neupré | Luik | 4120 | Belgium |
| Debry Jean-Yves | Ougrée | Luik | 4102 | Belgium |
| Evrard Antoine | Tilff | Luik | 4130 | Belgium |
| Parada Alberto | Trois-Ponts | Luik | 4980 | Belgium |
| Cohnen Ingrid | Waimes | Luik | 4950 | Belgium |
| Germay Arlette | Libin | Luxemburg | 6890 | Belgium |
| Gueibe France | Libin | Luxemburg | 6890 | Belgium |
| De Vleeschouwer Oriane | Saint-Hubert | Luxemburg | 6870 | Belgium |
| Vanschepdael Céline | Saint-Hubert | Luxemburg | 6870 | Belgium |
| Mattart Jacques | Andenne | Namen | 5300 | Belgium |
| Lafontaine Jean Baptiste | Namur | Namen | 5000 | Belgium |
| Kerckvoorde Lien | Aalter | Oost-Vlaanderen | 9880 | Belgium |
| Mahieu Inge | Asper | Oost-Vlaanderen | 9890 | Belgium |
| Cuelenaere Maarten | Assenede | Oost-Vlaanderen | 9960 | Belgium |
| De Sadeleer Jo | Borsbeke | Oost-Vlaanderen | 9552 | Belgium |
| Degrave Stijn | Herzele | Oost-Vlaanderen | 9550 | Belgium |
| De Muynck Kim | Kaprijke | Oost-Vlaanderen | 9970 | Belgium |
| Van Marcke Maarten | Lebbeke | Oost-Vlaanderen | 9280 | Belgium |
| Joos Ellen | Nevele | Oost-Vlaanderen | 9580 | Belgium |
| Everaert Leen | Nevele | Oost-Vlaanderen | 9850 | Belgium |
| Vermeulen Sofie | Sint-Martens-Latem | Oost-Vlaanderen | 9830 | Belgium |
| Heyerick Maaike | Zulte | Oost-Vlaanderen | 9870 | Belgium |
| Lemlijn Nathalie | Kessel-Lo | Vlaams-Brabant | 3010 | Belgium |
| Heijmans Stephane | Linkebeek | Vlaams-Brabant | 1630 | Belgium |
| Pening Maud | Nivelles | Waals-Brabant | 1400 | Belgium |
| Lens Marie | Ottignies | Waals-Brabant | 1340 | Belgium |
| Massaux Godelieve | Wavre | Waals-Brabant | 1300 | Belgium |
| De Vlieghere Marieke | Jabbeke | West-Vlaanderen | 8490 | Belgium |
| Caenepeel Laurens | Koksijde | West-Vlaanderen | 8670 | Belgium |
| Delvaux Nicolas | Lissewege | West-Vlaanderen | 8380 | Belgium |
| Knockaert Iris | Lissewege | West-Vlaanderen | 8380 | Belgium |
| Demeyere Tijs | Moorslede | West-Vlaanderen | 8890 | Belgium |
| Vandenameele Steffi | Sijsele | West-Vlaanderen | 8340 | Belgium |
| De Sutter Inge | Aalst | Belgium |
| Maenen Arjen | Alken | Belgium |
| Janssen Marie-Eve | Ans | Belgium |
| Cramm Myrjam | Antwerp | 2000 | Belgium |
| Maus Katelijne | Antwerp | Belgium |
| Debanterlé Stéphane | Barvaux | 6940 | Belgium |
| Bourcy Gaelle | Bastogne | Belgium |
| Deckers Clementine B | Bastogne | Belgium |
| Vercruysse Klaas | Berchem | 9690 | Belgium |
| Balligand Elie | Beringen | Belgium |
| De Wilde Kristien | Beveren | Belgium |
| Maes Marc | Beverlo | Belgium |
| Van De Plas Flip | Boechout | 2530 | Belgium |
| Haemels Maria-Magdalena | Boortmeerbeek | Belgium |
| Cloetens Hanne | Bruges | Belgium |
| Maryssael Mia | Bruges | Belgium |
| Freson Micheline | Damme | Belgium |
| De Meulemeester Marc | Gozée | Belgium |
| Van Rossem Inès | Halle | Belgium |
| Compes Annick | Hannut | Belgium |
| (Mingneau Jannick) Bourguignon Sofie | Heers | Belgium |
| De Walsche Bram | Herentals | Belgium |
| Van Immerseel Ilke | Hove | Belgium |
| Devolder Tyrone | Kortrijk | Belgium |
| Maertens Katrien | Kortrijk | Belgium |
| Vanderbauwhede Stefanie | Kortrijk | Belgium |
| Staelens Toon | Lauwe | Belgium |
| Van Der Auwera Jolien | Lauwe | Belgium |
| Marganne Anneline | Liège | 4000 | Belgium |
| Lambert Fabienne | Liège | Belgium |
| Maury Olivier | Linkebeek | Belgium |
| Saintmar Hélène | Marche-en-Famenne | Belgium |
| Moeremans Paul | Mechelen | Belgium |
| Heyvaert Goedele | Merchtem | 1785 | Belgium |
| Muylaert Peter | Merelbeke | 9820 | Belgium |
| Peetermans Luc | Mol | Belgium |
| Wuyts Tinne | Mol | Belgium |
| Pierard Virginie | Monceau-sur-Sambre | Belgium |
| Grosjean Joël | Mont-sur-Marchienne | Belgium |
| Andries Laura | Mortsel | Belgium |
| De Groote Jaron | Oudenaarde | Belgium |
| Steeno Pieter | Putte | Belgium |
| Lemiengre Marieke | Roeselare | Belgium |
| Cardon Philippe | Sambreville | 5060 | Belgium |
| Meuris Michel | Spa | Belgium |
| De Neef Sara | Tienen | Belgium |
| Op De Beeck Sabine | Turnhout | 2300 | Belgium |
| Froidcoeur Xavier | Wanze | Belgium |
| Tilquin Marlene | Wanze | Belgium |
| Janssen Reinhilde | Watervliet | Belgium |
| Bayens Kris | Weelde | Belgium |
| Klaasen Geert | Weelde | Belgium |
| Hertegonne Nele | Zottegem | Belgium |
| Coteur K, Henrard G, Schoenmakers B, Laenen A, Van den Broeck K, De Sutter A, Anthierens S, Devroey D, Kacenelenbogen N, Offermans AM, Van Nuland M. Blended care to discontinue benzodiazepine receptor agonists use in patients with chronic insomnia disorder: a pragmatic cluster randomized controlled trial in primary care. Sleep. 2023 Apr 12;46(4):zsac278. doi: 10.1093/sleep/zsac278. |
| 32075832 | Derived | 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. |
| Jul 6, 2022 |
| Prot_SAP_000.pdf |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Apr 24, 2023 | Jan 23, 2024 |