Brief Intervention for Sleep Medication Misuse Among Elderly

Not Applicable

Recruiting

• Conditions: Harmful Use of Hypnotic
• Interventions: Behavioral: BI (Brief Intervention)

• Registration Number: NCT06032715
• Lead Sponsor: University Hospital, Akershus

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.

Study Timeline

• Study First Submitted: 2023-08-17
• Study First Submitted QC: 2023-09-07
• Study First Posted: 2023-09-13
• Study Start: 2023-10-09
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-13
• Last Update Posted: 2024-11-15
• Primary Completion: 2024-12-30
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BI (Brief Intervention)	BI (Brief Intervention)	Patients whose GPs have been taught the behavioral BI intervention aiming to reduce prolonged use of Z-hypnotics.

Primary Outcome Measures

Name	Time	Method
Inappropriate Z-hypnotics use	6 weeks	Proportion of patients with prolonged use of Z-hypnotics

Secondary Outcome Measures

Name	Time	Method
Pain visual analogue scale (VAS)	6 weeks	VAS assessment of experienced pain (1-100 mm, no pain (0), worst possible pain (100))
Change compared to baseline of Z-hypnotics use	6 months	Proportion of patients with prolonged use of Z-hypnotics
Experience of sleep	6 months	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. .)
Cognitive function	6 months	Cognistat test total score (0-84, 84 best)
Sleep efficiency (random subpopulation)	6 weeks	Actigraphy assessed before and after intervention
Inappropriate Z-hypnotics use	baseline	Proportion of patients with prolonged use of Z-hypnotics

Trial Locations

Locations (1)

Akershus University Hospital; 🇳🇴 Lørenskog, Norway