Brief Intervention for Sleep Medication Misuse Among Elderly

Официальное название

Brief Intervention for Reducing Prolonged Use of Sleep Medication Among Elderly

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое BI (Brief Intervention)
  Short structured individual behavioral intervention to reduce inappropriate usage of Z-hypnotics

Первичные конечные точки

• Inappropriate Z-hypnotics use [Срок оценки: 6 weeks]

Вторичные конечные точки (9)

• Pain visual analogue scale (VAS) [Срок оценки: 6 weeks]
• Cognitive function [Срок оценки: 6 weeks]
• Cognitive function [Срок оценки: 6 months]
• Experience of sleep [Срок оценки: 6 weeks]
• Experience of sleep [Срок оценки: 6 months]
• Sleep efficiency (random subpopulation) [Срок оценки: 6 weeks]
• Change compared to baseline of Z-hypnotics use [Срок оценки: 6 weeks]
• Change compared to baseline of Z-hypnotics use [Срок оценки: 6 months]
• Inappropriate Z-hypnotics use [Срок оценки: baseline]

Критерии участия

Критерии включения

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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Организация здравоохранения

Центры проведения

Норвегия · 1 центр

• Akershus University Hospital — Lørenskog

Публикации

• 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. PMID 25112307
• 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. PMID 25179065
• 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. PMID 26645391
• 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. PMID 28544265
• 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. PMID 31234786
• 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. PMID 32718926
• 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. PMID 33143713
• 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. PMID 34913326

Идентификаторы

NCT: NCT06032715 · BI-sleep

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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