Ignite Creation Date:
2024-05-05 @ 8:04 PM
Last Modification Date:
2024-10-26 @ 9:57 AM
Study NCT ID:
NCT00792974
Status:
UNKNOWN
Last Update Posted:
2009-02-05
First Post:
2008-11-17
Brief Title:
End-of-Life Fear in Patients With End-Stage Lung Disease COPD
Sponsor:
Philipps University Marburg Medical Center
Organization:
Philipps University Marburg Medical Center
Study Overview
Official Title:
End-of-Life Fear in Patients With End-Stage Lung Disease Fears of Death and Dying Wishes and Needs of Patients With Severe COPD
Status:
UNKNOWN
Status Verified Date:
2009-02
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
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 andor anxiety disorder Despite this the majority of COPD patients with co-morbid disorders dont 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
Methods
Initially a systematic literature review was performed to determine what methods are being used in COPD studies and how the patients views can be best assessed Then a qualitative multi-method design will be used involving semi-structured interviews standardized questionnaires and lung function parameters
The face-to-face interview includes ten categories with more than 70 questions on
1 social demography
2 actual health status
3 knowledge and wishes of further information about the disease
4 thoughts and attitudes about the illness
5 fears about the illness treatment and prognosis
6 general experiences of death and dying
7 own experiences with death and dying
8 fear of death
9 fear of dying
10 end-of-life decisions such as wishes and needs
Patients will be interviewed by a single interviewer Each question will be read by using everyday language Interviews will be audiotaped to control for integrity Each interview will last approximately 60 minutes The interview will be validated by the COPD-Anxiety-Questionnaire CAF To assess the patients cognitions about death a self-report questionnaire FIMEST will be also used
Standardized questionnaires will be used to detect depression or panic disorders by the Hospital Anxiety and Depression Scale Functional health status will be measured by the Patients Health Questionnaire PHQ and the COPD-Disability- Index CDI The condition specific questionnaire the Short Form-36 Health Survey SF-36 and Euroqol EQ will be compared for their discriminative and evaluative properties Spirometric tests and a walking test will be also performed
After the interview those patients who have increased death anxiety take part in a brief psychological intervention to discuss their end-of-life issues worries and fears For this psychological intervention a manualized 2-3-session approach will be used
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 andor anxiety disorder Despite this the majority of COPD patients with co-morbid disorders dont 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
Methods
Initially a systematic literature review was performed to determine what methods are being used in COPD studies and how the patients views can be best assessed Then a qualitative multi-method design will be used involving semi-structured interviews standardized questionnaires and lung function parameters
The face-to-face interview includes ten categories with more than 70 questions on
1 social demography
2 actual health status
3 knowledge and wishes of further information about the disease
4 thoughts and attitudes about the illness
5 fears about the illness treatment and prognosis
6 general experiences of death and dying
7 own experiences with death and dying
8 fear of death
9 fear of dying
10 end-of-life decisions such as wishes and needs
Patients will be interviewed by a single interviewer Each question will be read by using everyday language Interviews will be audiotaped to control for integrity Each interview will last approximately 60 minutes The interview will be validated by the COPD-Anxiety-Questionnaire CAF To assess the patients cognitions about death a self-report questionnaire FIMEST will be also used
Standardized questionnaires will be used to detect depression or panic disorders by the Hospital Anxiety and Depression Scale Functional health status will be measured by the Patients Health Questionnaire PHQ and the COPD-Disability- Index CDI The condition specific questionnaire the Short Form-36 Health Survey SF-36 and Euroqol EQ will be compared for their discriminative and evaluative properties Spirometric tests and a walking test will be also performed
After the interview those patients who have increased death anxiety take part in a brief psychological intervention to discuss their end-of-life issues worries and fears For this psychological intervention a manualized 2-3-session approach will be used
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None