Brief Intervention for Sleep Medication Misuse Among Elderly (BI-sleep)

Brief Intervention for Reducing Prolonged Use of Sleep Medication Among Elderly

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.

Study Overview

• Status: Recruiting
• Conditions: Harmful Use of Hypnotic
• Intervention / Treatment: Behavioral: BI (Brief Intervention)

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.

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tahreem G Siddiqui, PhD; Phone Number: +47 90600984; Email: tahs@ahus.no

Study Locations

• Norway
  • Lørenskog, Norway
    • Recruiting
    • Akershus University Hospital
    • Contact: C Lundqvist, MD, PhD
    • Principal Investigator: Christofer Lundqvist, MD, PhD
    • Sub-Investigator: Tahreem G Siddiqui, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: BI (Brief Intervention); Patients whose GPs have been taught the behavioral BI intervention aiming to reduce prolonged use of Z-hypnotics.	Behavioral: BI (Brief Intervention); Short structured individual behavioral intervention to reduce inappropriate usage of Z-hypnotics
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Inappropriate Z-hypnotics use	Proportion of patients with prolonged use of Z-hypnotics	6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cognitive function	Cognistat test total score (0-84, 84 best)	6 weeks
Cognitive function	Cognistat test total score (0-84, 84 best)	6 months
Experience of sleep	Global Sleep Assessment Questionnaire score (GSAQ) (11 items, Never, sometimes, usually, always. Item responses were converted to a common 0-100 scale, with a higher score indicating greater likelihood for presence of the disorder. .)	6 weeks
Experience of sleep	Global Sleep Assessment Questionnaire score (GSAQ) (11 items, Never, sometimes, usually, always. Item responses were converted to a common 0-100 scale, with a higher score indicating greater likelihood for presence of the disorder. .)	6 months
Sleep efficiency (random subpopulation)	Actigraphy assessed before and after intervention	6 weeks
Change compared to baseline of Z-hypnotics use	Proportion of patients with prolonged use of Z-hypnotics	6 weeks
Change compared to baseline of Z-hypnotics use	Proportion of patients with prolonged use of Z-hypnotics	6 months
Inappropriate Z-hypnotics use	Proportion of patients with prolonged use of Z-hypnotics	baseline
Pain visual analogue scale (VAS)	VAS assessment of experienced pain (1-100 mm, no pain (0), worst possible pain (100))	6 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain visual analogue scale (VAS)	VAS assessment of experienced pain (1-100 mm, no pain (0), worst possible pain (100))	6 months
Quality of life measure, index	Euro QoL, five dimension, 5 level version (EQ-5D-5L index, Norwegian population norms valuation), 0-1 with 1 representing perfect health	6 months
Quality of life measure, VAS	Euro QoL, five dimension, 5 level version (EQ-5D VAS), 0-100 with 100 representing best health	6 months
Dependence score	Severity of dependence score (SDS), 0-15, 15 highest severity	6 weeks
Dependence score	Severity of dependence score (SDS), 0-15, 15 highest severity	6 months
MoCa score	Telefon - Montreal Cognitive Assessment (T-MoCA) for remote assessments. (0-22 points, normal cognition ≥ 18 / 22)	6 weeks
Self assessed cognitive function	Norwegian cognitive function instrument (KFI) (0-13 points yes=1 point, maybe=0,5 point, no=0 point)	6 weeks
Verbal fluency	FAS score (60 seconds timecap, using a cut-off score of 14 points indicating executive function deficits)	6 weeks
Multimorbidity	Cumulative Illness Rating Scale-Geriatric (CIRS-G) 0-56, 56 worst	6 weeks
Multimorbidity	Cumulative Illness Rating Scale-Geriatric (CIRS-G) 0-56, 56 worst	12 months
Polypharmacy	Number of regularly used medications	6 weeks
Readiness to change behaviour	Readiness to change behavior visual analogue scale scale, 0-100, 100 most ready	Baseline
Prevalence of inappropriate medication use in screened population	Patient self report in screening questionnaire	At screening before baseline
Prevalence self-reported sleep difficulties	Patient self report in screening questionnaire	At screening before baseline
Anxiety and depression symptoms	Hospital anxiety and depression scale (HADS), 0-42, 42 worst	6 weeks
Anxiety and depression symptoms	Hospital anxiety and depression scale (HADS), 0-42, 42 worst	6 months
Mortality	Based on automatic registration in electronic patient journal	12 months, 24 months
Cognitive function, subdimensions	Cognistat test, subdimensions score, higher score is better cognitive function	6 weeks
Cognitive function, subdimensions	Cognistat test, subdimensions score, higher score is better cognitive function	6 months
Inappropriate Z-hypnotics use	Proportion of patients with prolonged use of Z-hypnotics	6 months
Pain visual analogue scale (VAS)	VAS assessment of experienced pain (1-100 mm, no pain (0), worst possible pain (100))	12 months
Cognitive function	Cognistat test total score (0-84, 84 best)	12 months
Inappropriate Z-hypnotics use	Proportion of patients with prolonged use of Z-hypnotics	12 months
Change compared to baseline of Z-hypnotics use	Proportion of patients with prolonged use of Z-hypnotics	12 months
Quality of life measure, index	Euro QoL, five dimension, 5 level version (EQ-5D-5L index, Norwegian population norms valuation)	12 months
Quality of life measure, VAS	Euro QoL, 0 (worse) - 100(best)score (EQ-5D VAS)	12 months
Experience of sleep	Global Sleep Assessment Questionnaire score (GSAQ) (11 items, Never, sometimes, usually, always. Item responses were converted to a common 0-100 scale, with a higher score indicating greater likelihood for presence of the disorder. .)	12 months

Collaborators and Investigators

• Sponsor: University Hospital, Akershus
• Collaborators: University of Oslo
• Investigators: Study Chair: Christofer Lundqvist, MD, PhD, Akershus University Hospital and University of Oslo

Publications and helpful links

General Publications

• 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.

Helpful Links

• 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

Study record dates

Study Major Dates

• Study Start (Actual): October 9, 2023
• Primary Completion (Estimated): December 30, 2024
• Study Completion (Estimated): June 30, 2025

Study Registration Dates

• First Submitted: August 17, 2023
• First Submitted That Met QC Criteria: September 7, 2023
• First Posted (Actual): September 13, 2023

Study Record Updates

• Last Update Posted (Actual): November 15, 2024
• Last Update Submitted That Met QC Criteria: November 13, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: pain; sleep; behavioral intervention; quality of life; cognitive function; insomnia; dependence; side effects; Z-hypnotics
• Other Study ID Numbers: BI-sleep

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No