Brief Intervention for Reducing Prolonged Use of Sleep Medication Among Elderly
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Inappropriate Z-hypnotics use
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
GPs will be cluster randomized based on GP to two sequential teaching programs to learn the Brief Intervention procedure. The patients of those who have the course first will constitute the intervention arm while patients of GPs who are in the second course will constitute parallel business as usual controls in the masked part of the study. When the second group of GPs have their course, open cross-over will be possible.
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Self-reported use of Z-hypnotics > 4 days per week and > 4 weeks
排除标准
- •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
结局指标
主要结局
Inappropriate Z-hypnotics use
时间窗: 6 weeks
Proportion of patients with prolonged use of Z-hypnotics
次要结局
- 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)
研究者
Christofer Lundqvist
Professor
University Hospital, Akershus