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临床试验/NCT01879111
NCT01879111已完成不适用

Increasing the Efficiency of Depression-screening Using Patient-targeted Feedback: Randomized Controlled Trial

Universitätsklinikum Hamburg-Eppendorf4 个研究点 分布在 1 个国家目标入组 4,151 人开始时间: 2011年10月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
4,151
试验地点
4
主要终点
Level of depression one month after screening (Patient Health Questionnaire-9)

研究概览

简要总结

Out-patients with coronary heart disease or hypertension will fill out a depression screening questionnaire while waiting in a cardiac clinic. Using a randomised-controlled study design half of the patients will receive a patient-targeted written screening feedback. This feedback contains information about depression in general, depression-severity adapted treatment guidelines and contact-information for treatment. Patients in the control group receive no direct screening-feedback but their cardiologist will be informed about the screening result. All patients with a positive screening-result will be contacted after one month and six months and asked for symptoms of depression, and their use of health care. The aim of this study is to evaluate the efficiency of this minimal intervention on the course of depressive symptom in patients with known coronary heart disease or hypertension.

详细描述

The aim of this study is to evaluate the efficiency of a minimal intervention on the course of depressive symptoms in patients with known coronary heart disease (CHD) or hypertension. By means of a depression screening and individual patient-targeted feedback the level of depression should decrease, the percentage of treated depressed patients should increase and health economic costs should be lowered. The main hypothesis is that screening plus targeted feedback results in a greater reduction of depression than screening only.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Screening
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Gender: Both, male and female
  • Minimum Age: 18 Years
  • Maximum Age: no maximum age
  • Attendance in a cardiac clinic;
  • Clinical diagnosis of coronary heart disease or hypertension;
  • Age ≥ 18 years;
  • Sufficient language skills;
  • Informed consent

排除标准

  • Life threatening health status;
  • Severe somatic or/and psychological disorder that needs urgent treatment;
  • Acute suicidal tendency;
  • Severe cognitive or/and visual difficulties;
  • Not being able to fill out questionnaires

结局指标

主要结局

Level of depression one month after screening (Patient Health Questionnaire-9)

时间窗: One month after depression screening

次要结局

  • Level of depression six months after screening (Patient Health Questionnaire-9)(One month and six months after screening)
  • Proportion of patients treated for depression.(One month and six months after screening)
  • Direct and indirect health costs(One month and six months after screening)
  • Quality-adjusted years of life and quality of life (EuroQol-5D)(One month and six months after screening)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

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