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Blended Care for the Discontinuation of Benzodiazepine Use (Big Bird)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03937180
Recruitment Status : Active, not recruiting
First Posted : May 3, 2019
Last Update Posted : January 18, 2020
Sponsor:
Collaborators:
Belgium Health Care Knowledge Centre
Universiteit Antwerpen
University Ghent
Vrije Universiteit Brussel
Université Libre de Bruxelles
Université de Liège
Information provided by (Responsible Party):
Cathy Matheï, KU Leuven

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.

Condition or disease Intervention/treatment Phase
Benzodiazepine Dependence Benzodiazepine Dependent Benzodiazepine Withdrawal Behavioral: Blended care Behavioral: Usual care Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 924 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: cluster randomized controlled trial
Masking: None (Open Label)
Primary Purpose: Treatment
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.
Actual Study Start Date : June 24, 2019
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : May 2021

Arm Intervention/treatment
Usual care
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.
Behavioral: 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.

Experimental: Blended care
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.
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.




Primary Outcome Measures :
  1. Proportion of patients that discontinued (z-)BZD use at 12 months assessed by toxicological screening [ Time Frame: 12 months ]
    Long-term effect of a blended care approach versus usual care on the discontinuation of (z-)BZD


Secondary Outcome Measures :
  1. Proportion of patients that discontinued (z-)BZD use at 6 months assessed by toxicological screening [ Time Frame: 6 months ]
    Short-term effect of a blended care approach versus usual care on the discontinuation of (z-)BZD

  2. EQ-5D-3L assessed at week 6, 12, 26 and 52 [ Time Frame: 12 months ]
    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.

  3. Proportion of patients with self-reported discontinuation of (z-)BZD use assessed at week 6, 12, 26 and 52 [ Time Frame: 12 months ]
    Effect of a blended care approach versus usual care on self-reported discontinuation of (z-)BZD use

  4. The number of defined daily doses (DDD) of (z-)BZD prescribed in the preceding interval assessed at week 6, 12, 26 and 52 [ Time Frame: 12 months ]
    Effect of a blended care approach versus usual care on the number of DDD of benzodiazepines prescribed



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03937180


Locations
Show Show 99 study locations
Sponsors and Collaborators
Cathy Matheï
Belgium Health Care Knowledge Centre
Universiteit Antwerpen
University Ghent
Vrije Universiteit Brussel
Université Libre de Bruxelles
Université de Liège
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Cathy Matheï, Chief Investigator, KU Leuven
ClinicalTrials.gov Identifier: NCT03937180    
Other Study ID Numbers: S61194
KCE-17016 ( Other Grant/Funding Number: KCE )
First Posted: May 3, 2019    Key Record Dates
Last Update Posted: January 18, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

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 December 2022 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.

Supporting Materials: Study Protocol
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: 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 December 2022. For any request later than this date, follow-up by the Sponsor cannot be guaranteed.
Access Criteria: 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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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Cathy Matheï, KU Leuven:
benzodiazepines
blended care