Benzodiazepines DeprescribingEND-IT NHNCT05929443
Benzodiazepines Deprescribing in Nursing Homes: Intervention Feasibility
A study testing END-IT intervention for nursing homes in people with Benzodiazepines Deprescribing, run by Université Catholique de Louvain at 1 site in Belgium.
Trial summary
The goal of this feasibility study is to evaluate the feasibility of a complex intervention towards benzodiazepines and Z-drugs deprescribing in older adults living in the Belgian nursing home setting. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Benzodiazepines Deprescribing
- What is being tested?
- END-IT intervention for nursing homes
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteBelgium
- Study dates
- 22 Jun 2023to Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 65 years old and older
- Taking at least one benzodiazepine or Z-drug for 4 weeks or more
Who cannot join
- Unability to communicate in French
- Palliative care
- Ongoing benzodiazepine withdrawal
- Ongoing alcohol withdrawal
- Severe anxiety
- Severe depression
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
UCLouvain
Woluwe-Saint-Lambert, 1200
Perrine Evrard, MPharm, +3227647236, perrine.evrard@uclouvain.be
About this study
Official title: Feasibility of a Theory-based Benzodiazepines Deprescribing Intervention in Belgian Nursing Homes: the END-IT Study
The goal of this feasibility study is to evaluate the feasibility of a complex intervention towards benzodiazepines and Z-drugs deprescribing in older adults living in the Belgian nursing home setting.
The main questions it aims to answer are:
Read more
- Is the intervention we developped feasible
- To what extent will the intervention be implemented in nursing homes
- To what extent is the design of the recruitment and data collection process feasible and acceptable for all participants
Participants will benefit from a complex intervention implemented at the level of the nursing home, encompassing process and goals setting, healthcare providers education, environmental adaptations, audit and feedback on benzodiazepines use, use of educational leaflet with residents and relatives, and multidisciplinary work.
Researchers will compare this intervention to usual care, to see if the intervention is feasible, and to gather first data on intervention effectiveness in benzodiazepines deprescriping.
- Conditions
- Benzodiazepines Deprescribing
- Being tested
- END-IT intervention for nursing homes
- Keywords
- Benzodiazepines, Deprescribing, Long-term care, Older adults
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
END-IT intervention for nursing homesOther
Complex intervention, as described in the arm/group descriptions
| Study group | Role | What they receive |
|---|---|---|
| END-IT intervention for nursing homes | Experimental | This complex intervention, implemented at the level of the nursing home, encompasses process and goals setting, education for healthcare providers, environmental adaptations, audit and feedback on benzodiazepine use, use of an educational leaflet for residents and relatives, and multidisciplinary work. Receives: Other: END-IT intervention for nursing homes |
| Control | No intervention | Usual care. Nursing homes allocated to this study arm will access intervention material at the end of the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nursing homes' adherence to the intervention
has the intervention been implemented as intended, e.g. global number of implemented intervention components
Measured: Assessed at 6 months
Healthcare providers responsiveness to the intervention
has far did they respond to the intervention, and how far have them been engaged by the intervention, e.g level of attendance to education session for healthcare providers
Measured: Assessed at 6 months
nursing home residents' responsiveness to the intervention
has far did they respond to the intervention, and how far have them been engaged by the intervention
Measured: Assessed at 6 months
Feasibility of the recruitment process
The feasibility of the recruitment will be assessed through the ratio between included residents and residents contacted for participation.
Measured: At 6 months
Feasibility of the data collection process
Data collection process will be assessed through the quality of collected data (rate of missing data)
Measured: At 6 months
Secondary outcomes (7)
Contextual factors at the level of of the nursing home
Use of a questionnaire to assess factors that could explain potential differences in intervention implementation between nursing homes
Measured: Baseline
Contextual factors at the level of the nursing home resident
Use of a questionnaire to assess factors that could explain potential differences in intervention implementation between nursing home residents
Measured: Baseline
Intervention mechanisms of impact
Use of a questionnaire to assess intervention mechanisms of impact, in relation with how the intervention is supposed to have its impact
Measured: At baseline
Intervention mechanisms of impact
Use of a questionnaire to assess intervention mechanisms of impact, in relation with how the intervention is supposed to have its impact.
Measured: At 3 months
Intervention mechanisms of impact
Use of a questionnaire to assess intervention mechanisms of impact, in relation with how the intervention is supposed to have its impact.
Measured: At 6 months
Exploratory benzodiazepine deprescribing rate analysis
Defined as either a complete benzodiazepine/Z-drug cessation, or a dose reduction
Measured: At 3 months
Exploratory benzodiazepine deprescribing rate analysis
Defined as either a complete benzodiazepine/Z-drug cessation, or a dose reduction
Measured: At 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2023
- Study start22 Jun 2023
- Primary completionJan 2024 (estimated)
- Study completionJun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Benzodiazepines DeprescribingStudies of the same condition, open and under way.
- More trials run by Université Catholique de LouvainThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Université Catholique de Louvain
- Sponsor type
- University, hospital or other
- Collaborators
- EBPracticenet, Fonds National de la Recherche Scientifique
- Responsible party
- Sponsor
- Investigators
- Anne Spinewine, PhD, Principal investigator, UCLouvain / Louvain Drug Research Institute / Clinical pharmacy research group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05929443
- Sponsor's protocol ID
- CLIP/2023/02
- Acronym
- END-IT NH
- Status last verified
- Jun 2023
- First submitted
- 23 May 2023
- Last updated
- 3 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Only publishable project data relating to the main analysis and research output will be shared on a data repository after an embargo period of two years after June 2024. All relevant documentation necessary to facilitate data re-use will be shared along with the datasets.
Publications
Evrard P, Chevallereau T, Aikpitanyi J, Petein C, Tubeuf S, Henrard S, Spinewine A. Feasibility of a theory-based intervention towards benzodiazepine deprescribing in Belgian nursing homes: protocol of the END-IT NH cluster-randomised controlled trial. BMJ Open. 2024 Oct 22;14(10):e085435. doi: 10.1136/bmjopen-2024-085435.
PubMed 39438099
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of a Theory-based Benzodiazepines Deprescribing Intervention in Belgian Nursing Homes: the END-IT Study
- ClinicalTrials.gov ID
- NCT05929443
- Acronym / sponsor ID
- END-IT NH / CLIP/2023/02
- Conditions
- Benzodiazepines Deprescribing
- Keywords
- Benzodiazepines, Deprescribing, Long-term care, Older adults
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Université Catholique de LouvainUniversity, hospital or other
- Collaborators
- EBPracticenet, Fonds National de la Recherche Scientifique
- Study start
- 22 Jun 2023 (actual)
- Primary completion
- Jan 2024 (estimated)
- Study completion
- Jun 2024 (estimated)
- First posted
- 3 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this feasibility study is to evaluate the feasibility of a complex intervention towards benzodiazepines and Z-drugs deprescribing in older adults living in the Belgian nursing home setting.
The main questions it aims to answer are:
- Is the intervention we developped feasible
- To what extent will the intervention be implemented in nursing homes
- To what extent is the design of the recruitment and data collection process feasible and acceptable for all participants
Participants will benefit from a complex intervention implemented at the level of the nursing home, encompassing process and goals setting, healthcare providers education, environmental adaptations, audit and feedback on benzodiazepines use, use of educational leaflet with residents and relatives, and multidisciplinary work.
Researchers will compare this intervention to usual care, to see if the intervention is feasible, and to gather first data on intervention effectiveness in benzodiazepines deprescriping.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| END-IT intervention for nursing homes | Experimental | Other: END-IT intervention for nursing homesThis complex intervention, implemented at the level of the nursing home, encompasses process and goals setting, education for healthcare providers, environmental adaptations, audit and feedback on benzodiazepine use, use of an educational leaflet for residents and relatives, and multidisciplinary work. |
| Control | No intervention | –Usual care. Nursing homes allocated to this study arm will access intervention material at the end of the study. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- 65 years old and older
- Taking at least one benzodiazepine or Z-drug for 4 weeks or more
Key exclusion criteria (6 listed)
- Unability to communicate in French
- Palliative care
- Ongoing benzodiazepine withdrawal
- Ongoing alcohol withdrawal
- Severe anxiety
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| END-IT intervention for nursing homesComplex intervention, as described in the arm/group descriptions | Other | END-IT intervention for nursing homes |
Primary outcome
Nursing homes' adherence to the intervention
Time frame: Assessed at 6 months
has the intervention been implemented as intended, e.g. global number of implemented intervention components
Healthcare providers responsiveness to the intervention
Time frame: Assessed at 6 months
has far did they respond to the intervention, and how far have them been engaged by the intervention, e.g level of attendance to education session for healthcare providers
nursing home residents' responsiveness to the intervention
Time frame: Assessed at 6 months
has far did they respond to the intervention, and how far have them been engaged by the intervention
Feasibility of the recruitment process
Time frame: At 6 months
The feasibility of the recruitment will be assessed through the ratio between included residents and residents contacted for participation.
Feasibility of the data collection process
Time frame: At 6 months
Data collection process will be assessed through the quality of collected data (rate of missing data)
7 secondary outcomes
Contextual factors at the level of of the nursing home
Time frame: Baseline
Contextual factors at the level of the nursing home resident
Time frame: Baseline
Intervention mechanisms of impact
Time frame: At baseline
Intervention mechanisms of impact
Time frame: At 3 months
Intervention mechanisms of impact
Time frame: At 6 months
Exploratory benzodiazepine deprescribing rate analysis
Time frame: At 3 months
Exploratory benzodiazepine deprescribing rate analysis
Time frame: At 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2023.
- Derived from this study: PubMed 39438099Evrard P, Chevallereau T, Aikpitanyi J, Petein C, Tubeuf S, Henrard S, Spinewine A. Feasibility of a theory-based intervention towards benzodiazepine deprescribing in Belgian nursing homes: protocol of the END-IT NH cluster-randomised controlled trial. BMJ Open. 2024 Oct 22;14(10):e085435. doi: 10.1136/bmjopen-2024-085435.
- Individual participant dataSharing planned: No. Only publishable project data relating to the main analysis and research output will be shared on a data repository after an embargo period of two years after June 2024. All relevant documentation necessary to facilitate data re-use will be shared along with the datasets.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anne Spinewine, PhD principal investigator
UCLouvain / Louvain Drug Research Institute / Clinical pharmacy research group
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing END-IT intervention for nursing homes in people with Benzodiazepines Deprescribing, run by Université Catholique de Louvain at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Perrine Evrard, MPharm (+3227647236, perrine.evrard@uclouvain.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nursing homes' adherence to the intervention (time frame: Assessed at 6 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05929443, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2023.