The Treatment of Insomnia in Primary Care: Evaluating and Improving Compliance to Clinical Practice Guidelines
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 485
- 试验地点
- 2
- 主要终点
- Change in patient reported insomnia symptoms using the Insomnia Severity Index (ISI)
研究概览
简要总结
The goal of this clinical trial is to learn if training primary care providers on treatment of insomnia can improve insomnia symptoms in patients. Researchers will compare insomnia symptoms of patients receiving care from trained practices with patients receiving care from control practices (providing care-as-usual), to see if the training helps to provide improved insomnia care. Participants will be asked to complete four questionnaires and some participants will be invited for an insomnia consultation in primary care by their primary care providers (PCP).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •for a patient to be eligible to participate in this study:
- •Patient registered with a participating primary care facility and willing to provide informed consent AND
- •Survey confirmed presence of insomnia symptoms at least 3 times a week during at least the last 3 weeks AND
- •Survey shown increased score on the Insomnia Severity Index (ISI ≥ 11) AND
- •Survey shown interference with daily functioning on the Insomnia Severity Scale.
排除标准
- •Patients meeting any of the following criteria in the survey will be excluded from participation in this study:
- •Shift work for individuals awakening outside the hours 4:00 A.M. and 10:00 A.M. or going to bed outside the hours of 8:00 P.M. and 2:00 A.M. more than twice a week
- •Other sleep-wake disorders including chronic obstructive sleep apnea, bruxism and narcolepsy, restless leg syndrome and parasomnia.
- •Current pregnancy
- •Presence of epilepsy, schizophrenia, bipolar disorder, post-traumatic stress disorder or dementia in medical history
结局指标
主要结局
Change in patient reported insomnia symptoms using the Insomnia Severity Index (ISI)
时间窗: From baseline to measurements at 2, 6 and 12 months
Change is measured linearly using the Insomnia Severity Index. Scores range from 0 to 28 points in which higher scores represent a worse outcome. Secondly, the categorically defined treatment response is established 2 months after baseline questionnaire (remission = ISI score \< 11, ISI score reduction ≥ 8).
次要结局
- Change in patient reported depression symptoms(From baseline to measurements at 2, 6 and 12 months)
- Report by the PCP of a non-pharmacological 'sleep consultation'(12 months after baseline questionnaire)
- Change in patient reported anxiety symptoms(From baseline to measurements at 2, 6 and 12 months)
- Patient reported non-pharmacological 'sleep consultation'(12 months after baseline questionnaire)
- Change in report of sleep medication use(From baseline to measurements at 2, 6 and 12 months)
- Change in patient reported general health status(From baseline to measurements at 2, 6 and 12 months)
研究者
menumans
Prof. dr. M.E. Numans
Leiden University Medical Center