Brief Intervention for Reducing Prolonged Use of Sleep Medication Among Elderly
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Harmful Use of Hypnotic
- Sponsor
- University Hospital, Akershus
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- Inappropriate Z-hypnotics use
- Status
- Recruiting
- Last Updated
- last year
Overview
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.
Investigators
Christofer Lundqvist
Professor
University Hospital, Akershus
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
Outcomes
Primary Outcomes
Inappropriate Z-hypnotics use
Time Frame: 6 weeks
Proportion of patients with prolonged use of Z-hypnotics
Secondary Outcomes
- Pain visual analogue scale (VAS)(6 weeks)
- Change compared to baseline of Z-hypnotics use(6 months)
- Experience of sleep(6 months)
- Cognitive function(6 months)
- Sleep efficiency (random subpopulation)(6 weeks)
- Inappropriate Z-hypnotics use(baseline)