End-of-Life Fear in Patients With End-Stage Lung Disease (COPD) - Full Text View

Sponsors and Collaborators:	Philipps University Marburg Medical Center AstraZeneca
Information provided by:	Philipps University Marburg Medical Center
ClinicalTrials.gov Identifier:	NCT00792974

Purpose

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.

Condition	Intervention
Chronic Obstructive Pulmonary Disease End-of-Life Fear Fear About Death and Dying Depression	Behavioral: A brief psycho-educational intervention

MedlinePlus related topics: COPD (Chronic Obstructive Pulmonary Disease) Depression

U.S. FDA Resources

Study Type:	Observational
Study Design:	Case Control, Prospective
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

Further study details as provided by Philipps University Marburg Medical Center:

Primary Outcome Measures:

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 [ Time Frame: Pre-Post-Design including 2 assessment points: pre-treatment and post-treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

St. George's Respiratory Questionnaire (SGRQ) [ Time Frame: Pre-Post-Design including 2 assessment points: pre-treatment and post-treatment ] [ Designated as safety issue: No ]
Short Form Health Survey (Fragebogen zum allgemeinen Gesundheitszustand, SF-36) [ Time Frame: Pre-Post-Design including 2 assessment points: pre-treatment and post-treatment ] [ Designated as safety issue: No ]
Euroqol (EQ) [ Time Frame: Pre-Post-Design including 2 assessment points: pre-treatment and post-treatment ] [ Designated as safety issue: No ]
Patient Health Questionnaire (PHQ) [ Time Frame: Pre-Post-Design including 2 assessment points: pre-treatment and post-treatment ] [ Designated as safety issue: No ]
Hospital Anxiety and Depression Scale (HADS) [ Time Frame: Pre-Post-Design including 2 assessment points: pre-treatment and post-treatment ] [ Designated as safety issue: No ]
Borg Scale [ Time Frame: Pre-Post-Design including 2 assessment points: pre-treatment and post-treatment ] [ Designated as safety issue: No ]
Diffusion capacity (DLCO) [ Time Frame: Pre-Post-Design including 2 assessment points: pre-treatment and post-treatment ] [ Designated as safety issue: No ]
Blood gas analysis (BGA) [ Time Frame: Pre-Post-Design including 2 assessment points: pre-treatment and post-treatment ] [ Designated as safety issue: No ]
Bodyplethysmographs [ Time Frame: Pre-Post-Design including 2 assessment points: pre-treatment and post-treatment ] [ Designated as safety issue: No ]
Bio-Impedance-Analysis (BIA) [ Time Frame: Pre-Post-Design including 2 assessment points: pre-treatment and post-treatment ] [ Designated as safety issue: No ]
6-Minute Walk Distance (6 MWD) [ Time Frame: Pre-Post-Design including 2 assessment points: pre-treatment and post-treatment ] [ Designated as safety issue: No ]
Body Mass Index (BMI) [ Time Frame: Pre-Post-Design including 2 assessment points: pre-treatment and post-treatment ] [ Designated as safety issue: No ]
Blood tests [ Time Frame: Pre-Post-Design including 2 assessment points: pre-treatment and post-treatment ] [ Designated as safety issue: No ]
Multidimensional assessment of attitudes toward death and dying (Fragebogeninventar zur mehrdimensionalen Erfassung des Erlebens gegenüber Sterben und Tod, FIMEST) [ Time Frame: Pre-Post-Design including 2 assessment points: pre-treatment and post-treatment ] [ Designated as safety issue: No ]
COPD- Anxiety -Questionnaire (COPD-Angst-Fragebogen, CAF) [ Time Frame: Pre-Post-Design including 2 assessment points: pre-treatment and post-treatment ] [ Designated as safety issue: No ]
COPD- Disability- Index (CDI) [ Time Frame: Pre-Post-Design including 2 assessment points: pre-treatment and post-treatment ] [ Designated as safety issue: No ]
Differences in COPD admission rates, functional impairment, quality of life and end-of-life fear after treatment [ Time Frame: Pre-Post-Design including 2 assessment points: pre-treatment and post-treatment ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	199
Study Start Date:	October 2008
Estimated Study Completion Date:	July 2010
Estimated Primary Completion Date:	July 2010 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
COPD by GOLD-criteria III and IV	Behavioral: A brief psycho-educational intervention A brief (3 single sessions) psycho-educational program with cognitive-behavioral and disease self-management techniques. This study is an open pilot study ("feasibility study") to develop a palliative psychological program for end-of-life fears in COPD, therefore all participants will be given the opportunity to receive treatment.

Show Detailed Description

Eligibility

Ages Eligible for Study:	50 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes
Sampling Method:	Non-Probability Sample

Study Population

Subjects are recruited from the Pulmonary Rehabilitation Units of the Berchtesgadener Klinikum Schönau, Germany, through direct recruitment and use auf administrative databases. All patients who are alert and can provide 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 in match-able age.

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00792974

Contacts

Contact: Winfried Rief, Prof. Dr.	+49-6421-2823657	rief@staff.uni-marburg.de
Contact: Sabine R Pinzer, Dipl.-Psych.		spinzer@schoen-kliniken.de

Locations

Germany
Department of Clinical Psychology and Psychotherapy, Philipps University Marburg	Recruiting
Marburg, Germany, 35032
Contact: Winfried Rief, Prof. Dr. rief@staff.uni-marburg.de
Contact: Sabine R Pinzer, Dipl.-Psych. pinzer@staff.uni-marburg.de
Principal Investigator: Sabine R Pinzer, Dipl.-Psych.
Klinikum Berchtesgadener Land, Schön Kliniken	Recruiting
Schönau am Königssee, Germany, 83471
Contact: Klaus Kenn, Dr. kkenn@schoen-kliniken.de
Contact: Sabine R Pinzer, Dipl.-Psych. spinzer@schoen-kliniken.de

Sponsors and Collaborators

Philipps University Marburg Medical Center

AstraZeneca

Investigators

Principal Investigator:	Winfried Rief, Prof. Dr.	Department of Clinical Psychology and Psychotherapy, Philipps University Marburg, Germany
Study Director:	Klaus Kenn, Dr.	Klinikum Berchtesgadener Land, Schön Kliniken, Schönau a. K., Germany
Study Chair:	Sabine R Pinzer, Dipl.-Psych.	Department of Clinical Psychology and Psychotherapy, Philipps University Marburg, Germany

More Information

Responsible Party:	Department of Clinical Psychology and Psychotherapy ( Prof. Dr. W. Rief )
Study ID Numbers:	EoL
Study First Received:	November 17, 2008
Last Updated:	November 17, 2008
ClinicalTrials.gov Identifier:	NCT00792974
Health Authority:	Germany: Ethics Committee of Bavarian Medical Chamber

Keywords provided by Philipps University Marburg Medical Center:

Cognitive behavioral education
COPD (Chronic Obstructive Pulmonary Disease), GOLD II-IV

Study placed in the following topic categories:

Death
Lung Diseases, Obstructive
Depression
Respiratory Tract Diseases
Lung Diseases

Respiration Disorders
Depressive Disorder
Behavioral Symptoms
Pulmonary Disease, Chronic Obstructive

ClinicalTrials.gov processed this record on January 15, 2009