Brief Intervention for Sleep Medication Misuse Among Elderly
NCT ID: NCT06032715
Last Updated: 2024-11-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
120 participants
INTERVENTIONAL
2023-10-09
2025-06-30
Brief Summary
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Detailed Description
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Baseline assessments are limited to self reports and automatic sleep assessment with actigraphy to avoid assessment effects. Follow-up at main outcome time point is in person, some outcomes are also by telephone assessment and compared to baseline prior to intervention (e g Actigraphy assessment.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
QUADRUPLE
Study Groups
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BI (Brief Intervention)
Patients whose GPs have been taught the behavioral BI intervention aiming to reduce prolonged use of Z-hypnotics.
BI (Brief Intervention)
Short structured individual behavioral intervention to reduce inappropriate usage of Z-hypnotics
BAU (Business as usual)
Patients whose GPs have not yet been taught the BI intervention. Patients only assessed in parallel with BI group by masked assessors using same instruments as for active comparator.
This group also constitutes an open cross-over group to active intervention once the masked 6 months phase is completed.
No interventions assigned to this group
Interventions
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BI (Brief Intervention)
Short structured individual behavioral intervention to reduce inappropriate usage of Z-hypnotics
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* diagnosis of psychosis,
* diagnosis of major depression,
* diagnosis of delirium,
* unable to give informed consent,
* insufficient Norwegian language capacity to complete tests
60 Years
ALL
No
Sponsors
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University of Oslo
OTHER
University Hospital, Akershus
OTHER
Responsible Party
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Christofer Lundqvist
Professor
Principal Investigators
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Christofer Lundqvist, MD, PhD
Role: STUDY_CHAIR
Akershus University Hospital and University of Oslo
Locations
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Akershus University Hospital
Lørenskog, , Norway
Countries
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Central Contacts
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Facility Contacts
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C Lundqvist, MD, PhD
Role: primary
References
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Kristoffersen ES, Straand J, Vetvik KG, Benth JS, Russell MB, Lundqvist C. Brief intervention for medication-overuse headache in primary care. The BIMOH study: a double-blind pragmatic cluster randomised parallel controlled trial. J Neurol Neurosurg Psychiatry. 2015 May;86(5):505-12. doi: 10.1136/jnnp-2014-308548. Epub 2014 Aug 11.
Frich JC, Kristoffersen ES, Lundqvist C. GPs' experiences with brief intervention for medication-overuse headache: a qualitative study in general practice. Br J Gen Pract. 2014 Sep;64(626):e525-31. doi: 10.3399/bjgp14X681313.
Kristoffersen ES, Straand J, Vetvik KG, Benth JS, Russell MB, Lundqvist C. Brief intervention by general practitioners for medication-overuse headache, follow-up after 6 months: a pragmatic cluster-randomised controlled trial. J Neurol. 2016 Feb;263(2):344-353. doi: 10.1007/s00415-015-7975-1. Epub 2015 Dec 8.
Kristoffersen ES, Straand J, Russell MB, Lundqvist C. Lasting improvement of medication-overuse headache after brief intervention - a long-term follow-up in primary care. Eur J Neurol. 2017 Jul;24(7):883-891. doi: 10.1111/ene.13318. Epub 2017 May 23.
Cheng S, Siddiqui TG, Gossop M, Kristoffersen ES, Lundqvist C. The Severity of Dependence Scale detects medication misuse and dependence among hospitalized older patients. BMC Geriatr. 2019 Jun 24;19(1):174. doi: 10.1186/s12877-019-1182-3.
Siddiqui TG, Cheng S, Gossop M, Kristoffersen ES, Grambaite R, Lundqvist C. Association between prescribed central nervous system depressant drugs, comorbidity and cognition among hospitalised older patients: a cross-sectional study. BMJ Open. 2020 Jul 27;10(7):e038432. doi: 10.1136/bmjopen-2020-038432.
Siddiqui TG, Cheng S, Mellingsaeter M, Grambaite R, Gulbrandsen P, Lundqvist C, Gerwing J. "What should I do when I get home?" treatment plan discussion at discharge between specialist physicians and older in-patients: mixed method study. BMC Health Serv Res. 2020 Nov 3;20(1):1002. doi: 10.1186/s12913-020-05860-9.
Bjelkaroy MT, Cheng S, Siddiqui TG, Benth JS, Grambaite R, Kristoffersen ES, Lundqvist C. The association between pain and central nervous system depressing medication among hospitalised Norwegian older adults. Scand J Pain. 2021 Dec 16;22(3):483-493. doi: 10.1515/sjpain-2021-0120. Print 2022 Jul 26.
Siddiqui TG, Bjelkaroy MT, Cheng S, Kristoffersen ES, Grambaite R, Lundqvist C. The effect of cognitive function and central nervous system depressant use on mortality-A prospective observational study of previously hospitalised older patients. PLoS One. 2022 Mar 3;17(3):e0263024. doi: 10.1371/journal.pone.0263024. eCollection 2022.
Provided Documents
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Document Type: Statistical Analysis Plan: Statistical analysis plan screening data
Document Type: Statistical Analysis Plan: Statistical analysis plan main RCT
Related Links
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Humeniuk et al (2010), WHO: The Alcohol, Smoking and Substance involvement Screening Test (ASSIST): manual for use in primary care
Babor et al (2001), WHO: Brief intervention for hazardous and harmful drinking : a manual for use in primary care
Other Identifiers
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BI-sleep
Identifier Type: -
Identifier Source: org_study_id
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