Clinical trial NCT06032715: Brief Intervention for Sleep Medication Misuse Among Elderly
Official title: Brief Intervention for Reducing Prolonged Use of Sleep Medication Among Elderly
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Harmful Use of Hypnotic
Keywords: Z-hypnotics
insomnia
sleep
side effects
cognitive function
pain
behavioral intervention
dependence
quality of life
Lead sponsor: University Hospital, Akershus
Sponsor class: OTHER
Collaborators: name: University of Oslo
First posted: 2023-09-13
Enrollment: 120
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel masked and controlled first part intervention vs Business as usual with follow-up after 6 months by masked assessors. Subsequently open single cross-over of business as usual patients to also receive the same intervention.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Randomized controlled trial to evaluate effectiveness of behavioral Brief Intervention administered by General practitioners (GPs) versus business as usual on use of Z-hypnotics by elderly patients in primary care.

Detailed description: Two armed study with controlled masked first part over 6 months. Active arm is with Brief Intervention for inappropriate use of Z-hypnotics among elderly with intervention delivered by trained GPs. Control arm is for patients handled by their (non-trained) GPs with business as usual (BAU). Main outcome is 6 weeks after intervention with additional data collection points after 6 months (blinded) and long-term follow-up to 12 months (open). After 6 months there will be an open single crossover as BAU GPs will then also receive training in the Brief Intervention method.

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.

Eligibility criteria: Inclusion Criteria:

* Self-reported use of Z-hypnotics \> 4 days per week and \> 4 weeks

Exclusion Criteria:

* diagnosis of dementia,
* diagnosis of psychosis,
* diagnosis of major depression,
* diagnosis of delirium,
* unable to give informed consent,
* insufficient Norwegian language capacity to complete tests

Primary outcomes:
measure: Inappropriate Z-hypnotics use
timeFrame: 6 weeks
Secondary outcomes:
measure: Pain visual analogue scale (VAS)
timeFrame: 6 weeks
measure: Cognitive function
timeFrame: 6 weeks
measure: Cognitive function
timeFrame: 6 months
measure: Experience of sleep
timeFrame: 6 weeks
measure: Experience of sleep
timeFrame: 6 months
measure: Sleep efficiency (random subpopulation)
timeFrame: 6 weeks
measure: Change compared to baseline of Z-hypnotics use
timeFrame: 6 weeks
measure: Change compared to baseline of Z-hypnotics use
timeFrame: 6 months
measure: Inappropriate Z-hypnotics use
timeFrame: baseline
Other outcomes:
measure: Quality of life measure, index
timeFrame: 6 months
measure: Quality of life measure, VAS
timeFrame: 6 months
measure: Dependence score
timeFrame: 6 weeks
measure: Dependence score
timeFrame: 6 months
measure: MoCa score
timeFrame: 6 weeks
measure: Self assessed cognitive function
timeFrame: 6 weeks
measure: Verbal fluency
timeFrame: 6 weeks
measure: Multimorbidity
timeFrame: 6 weeks
measure: Multimorbidity
timeFrame: 12 months
measure: Polypharmacy
timeFrame: 6 weeks
measure: Readiness to change behaviour
timeFrame: Baseline
measure: Prevalence of inappropriate medication use in screened population
timeFrame: At screening before baseline
measure: Prevalence self-reported sleep difficulties
timeFrame: At screening before baseline
measure: Anxiety and depression symptoms
timeFrame: 6 weeks
measure: Anxiety and depression symptoms
timeFrame: 6 months
measure: Mortality
timeFrame: 12 months, 24 months
measure: Cognitive function, subdimensions
timeFrame: 6 weeks
measure: Cognitive function, subdimensions
timeFrame: 6 months
measure: Inappropriate Z-hypnotics use
timeFrame: 6 months
measure: Pain visual analogue scale (VAS)
timeFrame: 12 months
measure: Cognitive function
timeFrame: 12 months
measure: Inappropriate Z-hypnotics use
timeFrame: 12 months
measure: Change compared to baseline of Z-hypnotics use
timeFrame: 12 months
measure: Quality of life measure, index
timeFrame: 12 months
measure: Quality of life measure, VAS
timeFrame: 12 months
measure: Experience of sleep
timeFrame: 12 months
measure: Pain visual analogue scale (VAS)
timeFrame: 6 months
Locations:
city: Lørenskog
country: Norway
facility: Akershus University Hospital
Study officials:
affiliation: Akershus University Hospital and University of Oslo
name: Christofer Lundqvist, MD, PhD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.