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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2009 by Philipps University Marburg Medical Center.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
AstraZeneca
Information provided by:
Philipps University Marburg Medical Center
ClinicalTrials.gov Identifier:
NCT00792974
First received: November 17, 2008
Last updated: February 4, 2009
Last verified: February 2009
  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

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: 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

Resource links provided by NLM:


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 ]

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.

Other Names:
  • Cognitive-behavioral therapy
  • Palliative care

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

Responsible Party: Prof. Dr. W. Rief, Department of Clinical Psychology and Psychotherapy
ClinicalTrials.gov Identifier: NCT00792974     History of Changes
Other Study ID Numbers: EoL
Study First Received: November 17, 2008
Last Updated: February 4, 2009
Health Authority: Germany: Ethics Commission

Keywords provided by Philipps University Marburg Medical Center:
Cognitive behavioral education
COPD (Chronic Obstructive Pulmonary Disease), GOLD II-IV

Additional relevant MeSH terms:
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Depression
Lung Diseases
Respiratory Tract Diseases
Behavioral Symptoms

ClinicalTrials.gov processed this record on September 22, 2014