Non-interventional Observational Study on WHO-5 Questionnaire Application in Parkinson's Disease
2013年11月18日 更新者:Boehringer Ingelheim
Application of the WHO-5 Well-being Index (WHO-5) as a Screening Instrument for Depression in Parkinson's Disease
To assess the predictive value of sequential administration of WHO-5 and MDI (Major Depression Inventory) for the clinical management of Parkinson Disease (PD) patients by
- determination of the prevalence of depression in PD patients, based on MDI severity categories and the self-rating scale WHO-5, where poor well being was indicated.
- exploration of influencing factors (PD status, therapeutic status) on the prevalence of MDI depression categories.
研究概览
地位
完全的
条件
研究类型
观察性的
注册 (实际的)
1588
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
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Achim、德国
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Achim、德国
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Altenburg、德国
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Altenholz、德国
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Alzey、德国
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Aue、德国
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Bad Driburg、德国
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Bad Homburg、德国
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Bad Honnef、德国
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Bad Neuenahr-Ahrweiler、德国
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Bad Soden、德国
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Bad Soden、德国
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Bad Sooden-Allendorf、德国
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Bergisch Gladbach、德国
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Berlin、德国
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Berlin、德国
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Berlin、德国
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Berlin、德国
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Berlin、德国
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Berlin、德国
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Berlin、德国
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Berlin、德国
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Berlin、德国
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Berlin、德国
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Berlin、德国
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Berlin、德国
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Berlin、德国
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Berlin、德国
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Bielefeld、德国
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Bielefeld、德国
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Bochum、德国
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Bochum、德国
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Bochum、德国
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Bockhorn、德国
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Bonn、德国
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Braunschweig、德国
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Bremen、德国
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Bretten、德国
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Butzbach、德国
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Butzbach、德国
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Buxtehude、德国
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Castrop-Rauxel、德国
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Chemnitz、德国
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Delmenhorst、德国
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Dessau、德国
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Dietzenbach、德国
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Dortmund、德国
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Dortmund、德国
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Dresden、德国
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Dresden、德国
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Duisburg、德国
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Dülmen、德国
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Erbach、德国
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Frankfurt、德国
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Halle、德国
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Halle、德国
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Hamburg、德国
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Hamburg、德国
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Hamburg、德国
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Hannover、德国
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Hannover、德国
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Heidelberg、德国
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Henstedt-Ulzburg、德国
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Herborn、德国
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Herzberg、德国
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Herzogenrath、德国
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Hildesheim、德国
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Leipzig、德国
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Leipzig、德国
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Leipzig、德国
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Ludwigsfelde、德国
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Ludwigshafen、德国
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Ludwigshafen、德国
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Mannheim、德国
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Mönchengladbach、德国
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Mülheim、德国
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Mülheim、德国
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Mülheim、德国
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Münster、德国
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Riesa、德国
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Rostock、德国
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Velen、德国
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Velen、德国
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参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
30年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
取样方法
非概率样本
研究人群
resident physician
描述
Inclusion Criteria:
- PD patients attending one of the participating neurologist practices during 2 fixed weeks in November 2008
- Idiopathic PD with or without fluctuations
- Male or female PD patients aged at least 30
- Ability to reliably complete self-rating scales (WHO-5, MDI) ), according to the physician's judgement.
- Written informed consent by the patient for study participation.
Exclusion Criteria:
- PD Patients who only attend the practice to get a prescription and are not seen by the doctor on that day
- Patients who are not able to understand the questionnaires (e.g. due to mental impairment or language problems).
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
---|---|
Prevalence of patients with depressive symptoms (based on WHO-5 and MDI) in total and in subgroups
大体时间:day 1
|
day 1
|
次要结果测量
结果测量 |
大体时间 |
---|---|
WHO-5 score and items
大体时间:day 1
|
day 1
|
MDI score (for a subgroup of patients with WHO-5 score < 13 or any WHO-5 item rated with 0 or 1)
大体时间:day 1
|
day 1
|
Correlation of WHO-5 and MDI (for a subgroup of patients with a WHO-5 score < 13 or any WHO-5 item rated with 0 or 1) in PD patients
大体时间:day 1
|
day 1
|
Investigator assessment of the applicability of the WHO-5 for screening for depression in PD patients
大体时间:day 1
|
day 1
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2008年11月1日
初级完成 (实际的)
2008年11月1日
研究注册日期
首次提交
2008年9月12日
首先提交符合 QC 标准的
2008年9月12日
首次发布 (估计)
2008年9月15日
研究记录更新
最后更新发布 (估计)
2013年11月19日
上次提交的符合 QC 标准的更新
2013年11月18日
最后验证
2013年11月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.