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Completed

NCT Number: NCT03937180

Blended Care for the Discontinuation of Benzodiazepine Use

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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Key information

Conditions

Benzodiazepine Dependence Benzodiazepine Dependent Benzodiazepine Withdrawal

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Leysen Bert, Broechem, Antwerpen, Belgium

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Kristien Coteur

Other

Collaborators

  • Belgium Health Care Knowledge Centre
  • Universiteit Antwerpen
  • University Ghent
  • Université Libre de Bruxelles
  • Université de Liège
  • Vrije Universiteit Brussel

Registry information

Official study title

The Effectiveness of a Blended Care Program for the Discontinuation of Benzodiazepines Use for Sleeping Problems in Primary Care: a Clustered Randomized Trial.

Acronym: Big Bird

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
May 3, 2019
Registry last updated
Jul 15, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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