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临床试验/NCT00792974
NCT00792974Unknown不适用

End-of-Life Fear in Patients With End-Stage Lung Disease: Fears of Death and Dying, Wishes and Needs of Patients With Severe COPD

Philipps University Marburg Medical Center2 个研究点 分布在 1 个国家目标入组 199 人开始时间: 2008年10月最近更新:
适应症

试验速览

阶段
不适用
入组人数
199
试验地点
2
主要终点
Self-reported semi-structured interview about the fear of death and dying, needs and wishes at the end-of-life in patients with severe COPD

研究概览

简要总结

The aim of the study is to develop an interview to ask patients with COPD about their fear of death and dying, their needs and wishes at the end-of-life. Afterwards, the patients receive a brief psychological intervention to develop coping strategies for chronic illness. Beside this a general purpose of this intervention is to improve patients' quality of life.

详细描述

Background:

COPD-related mortality differs markedly from that of other chronic diseases. While the mortality rates for heart disease and stroke have fallen significantly, death rates caused by COPD have more than doubled. Therefore there is a major need to address questions of palliative end-of-life care. Patients with end-stage pulmonary lung diseases suffer from dyspnea, severe pain, fatigue and - the "deadlock" in end-of-life communication. Many people with severe COPD are socially isolated, have low quality of life and psychosocial challenges such as sadness, panic or hopelessness. In fact, 70 up to 90% suffer from a clinically relevant depression and/or anxiety disorder. Despite this, the majority of COPD patients with co-morbid disorders don't receive any treatment for their psychological symptoms. Furthermore, there is substantial evidence that only a minority of people with end-stage COPD have the opportunity to discuss their fears and wishes for end-of-life care. The few existing studies on this issue demonstrated that the majority of people with severe COPD wants to discuss topics such as prognosis, fear of death and dying or preferences and needs at the end-of-life. Understanding the nature and implications of treatment options is an important component of advanced care planning for people with end-stage lung disease.

Therefore the aim of this study is to bring up the end-of-life communication to patients with end-stage COPD. We hypothesize that end-stage COPD patients have greater fear of death and dying as patients with mild to moderate COPD or with hip prothesis (control group). The lowest anxiety rate with regard to death should be found in the healthy control group. Furthermore, a brief psychological intervention should decrease the co-morbid psychological symptoms and patients' fears. Higher quality of life should be achieved.

Objectives:

Subjects are recruited from the Pulmonary Rehabilitation Units of the Berchtesgadener Klinikum Schönau, Germany, through direct recruitment and use of administrative databases. All patients providing informed consent are invited to participate, if they have a chronic obstructive pulmonary disease with stage II, III or IV by GOLD-criteria. An open three group comparison is made of one-hundred patients with severe COPD (stage III and IV), thirty-three patients with moderate COPD (stage II), thirty-three patients with hip prosthesis and thirty-three mental healthy persons matched for age and sex. As we want to start a first feasibility intervention study, this is a clinical controlled design without randomization.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
50 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 50 years or older
  • COPD diagnosis III and IV by GOLD-criteria with or without an indication for long-term oxygen therapy (LTOT), non invasive ventilation (NIV) and/or lung transplantation (LTx)
  • COPD diagnosis II by GOLD-criteria
  • Patients with hip prosthesis
  • Mental healthy people, who have no severe illness (such as heart disease or cancer) one year before

排除标准

  • Participation in other studies likely to influence the patient in terms of confounding effects
  • Acute and severe exacerbations with hard symptoms over 4 days
  • Patients need a increasing medication of steroids and/or antibiotics
  • Non-compliance

结局指标

主要结局

Self-reported semi-structured interview about the fear of death and dying, needs and wishes at the end-of-life in patients with severe COPD

时间窗: Pre-Post-Design including 2 assessment points: pre-treatment and post-treatment

次要结局

  • St. George's Respiratory Questionnaire (SGRQ)(Pre-Post-Design including 2 assessment points: pre-treatment and post-treatment)
  • Short Form Health Survey (Fragebogen zum allgemeinen Gesundheitszustand, SF-36)(Pre-Post-Design including 2 assessment points: pre-treatment and post-treatment)
  • Euroqol (EQ)(Pre-Post-Design including 2 assessment points: pre-treatment and post-treatment)
  • Patient Health Questionnaire (PHQ)(Pre-Post-Design including 2 assessment points: pre-treatment and post-treatment)
  • Hospital Anxiety and Depression Scale (HADS)(Pre-Post-Design including 2 assessment points: pre-treatment and post-treatment)
  • Borg Scale(Pre-Post-Design including 2 assessment points: pre-treatment and post-treatment)
  • Diffusion capacity (DLCO)(Pre-Post-Design including 2 assessment points: pre-treatment and post-treatment)
  • Blood gas analysis (BGA)(Pre-Post-Design including 2 assessment points: pre-treatment and post-treatment)
  • Bodyplethysmographs(Pre-Post-Design including 2 assessment points: pre-treatment and post-treatment)
  • Bio-Impedance-Analysis (BIA)(Pre-Post-Design including 2 assessment points: pre-treatment and post-treatment)
  • 6-Minute Walk Distance (6 MWD)(Pre-Post-Design including 2 assessment points: pre-treatment and post-treatment)
  • Body Mass Index (BMI)(Pre-Post-Design including 2 assessment points: pre-treatment and post-treatment)
  • Blood tests(Pre-Post-Design including 2 assessment points: pre-treatment and post-treatment)
  • Multidimensional assessment of attitudes toward death and dying (Fragebogeninventar zur mehrdimensionalen Erfassung des Erlebens gegenüber Sterben und Tod, FIMEST)(Pre-Post-Design including 2 assessment points: pre-treatment and post-treatment)
  • COPD- Anxiety -Questionnaire (COPD-Angst-Fragebogen, CAF)(Pre-Post-Design including 2 assessment points: pre-treatment and post-treatment)
  • COPD- Disability- Index (CDI)(Pre-Post-Design including 2 assessment points: pre-treatment and post-treatment)
  • Differences in COPD admission rates, functional impairment, quality of life and end-of-life fear after treatment(Pre-Post-Design including 2 assessment points: pre-treatment and post-treatment)

研究者

申办方类型
Other

研究点 (2)

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