NCT06032715

Brief Intervention for Sleep Medication Misuse Among Elderly

Brief Intervention for Reducing Prolonged Use of Sleep Medication Among Elderly

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: University Hospital, Akershus · Academic / Other
• Sex: All
• Age: 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Harmful Use of Hypnotic

Interventions

Type	Name	Description
BEHAVIORAL	BI (Brief Intervention)	Short structured individual behavioral intervention to reduce inappropriate usage of Z-hypnotics

Timeline

• Start date: 2023-10-09
• Primary completion: 2024-12-30
• Completion: 2025-06-30
• First posted: 2023-09-13
• Last updated: 2024-11-15

Locations

1 site across 1 country: Norway