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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/28/2021.

Blended Care for the Discontinuation of Benzodiazepine Use

Clinicaltrials.gov identifier NCT03937180

Recruitment Status Active, not recruiting

First Posted May 3, 2019

Last update posted January 18, 2020

Study Description

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:Benzodiazepine Dependent
    Benzodiazepine Withdrawal
    Benzodiazepine Dependence
  • Intervention/Treatment: Behavioral: Blended care
    Behavioral: Usual care
  • Phase: N/A
Detailed Description

N/A

Study Design
  • Study Type: Interventional
  • 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 2019
  • Estimated Primary Completion Date: March 2021
  • Estimated Study Completion Date: May 2021
Arms and interventions
Arm Intervention/treatment
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.
Other: 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.
Outcome Measures
  • 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
Eligibility Criteria
  • 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.

Contacts and Locations
Contacts
Locations
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

More Information
  • Responsible Party: Cathy Matheï
  • ClinicalTrials.gov Identifier: NCT03937180 History of Changes
  • Other Study ID Numbers: S61194, KCE-17016
  • 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.
  • 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.: Yes
  • Keywords provided by Cathy Matheï: benzodiazepines blended care