The Influence of Personality on Pulmonary Fibrosis and Sarcoidosis

This study has been completed.
Sponsor:
Collaborator:
University of Tilburg
Information provided by (Responsible Party):
Maastricht University Medical Center
ClinicalTrials.gov Identifier:
NCT00504621
First received: July 19, 2007
Last updated: March 25, 2014
Last verified: March 2014
  Purpose

A number of studies have shown that the quality of life of two common interstitial lung diseases (ild), sarcoidosis and pulmonary fibrosis patients, is impaired and that fatigue is a substantial problem for those patients. Furthermore, breathlessness is an additional major problem in pulmonary fibrosis. In the field of cardiovascular disease and breast cancer, personality factors have shown to play a role in patient's morbidity, mortality, quality of life, fatigue, depressive symptoms, and one study showed a predictive role of personality factors in health care consumption. No studies examining personality factors have been performed in sarcoidosis or pulmonary fibrosis. Therefore, the aim of the present study is to examine the role of personality factors as predictors of fatigue, quality of life, prognosis, and health care consumption in sarcoidosis and pulmonary fibrosis. In this study a number of possible moderators, such as social support, will also be examined, aiming to get a full picture of the relationship between the various factors examined. Known and new sarcoidosis and pulmonary fibrosis patients (inclusion period 1 year) of ild care team of the outpatient clinic of the department of Respiratory Medicine of the University Hospital Maastricht will be asked to participate through completing questionnaires at baseline and every six months for 18 months, and allowing the researchers access to their medical records for the purpose of this study.


Condition
Sarcoidosis
Pulmonary Fibrosis

Study Type: Observational
Study Design: Time Perspective: Cross-Sectional
Official Title: The Influence of Personality on Quality of Life, Fatigue, Prognosis, and Health Care Consumption in Pulmonary Fibrosis and Sarcoidosis

Resource links provided by NLM:


Further study details as provided by Maastricht University Medical Center:

Primary Outcome Measures:
  • The role of personality factors as predictors in sarcoidosis and pulmonary fibrosis. [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    The role of personality factors as predictors of fatigue, quality of life, prognosis, and health care consumption in sarcoidosis and pulmonary fibrosis.


Enrollment: 450
Study Start Date: August 2007
Study Completion Date: January 2009
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts
sarcoidosis
Sarcoidosis known by the ild care team of the outpatient clinic of the department of Respiratory Medicine of the University Hospital Maastricht as well as new patients attending the out-patient clinic from August 2007 to January 2009
pulmonary fibrosis
Idiopathic pulmonary fibrosis (IPF) patients known by the ild care team of the outpatient clinic of the department of Respiratory Medicine of the University Hospital Maastricht as well as new patients attending the out-patient clinic from August 2007 to January 2009

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Sarcoidosis patients diagnosed according to WASOG guidelines and IPF patients diagnosed according ATS guidelines.

Criteria

Inclusion Criteria:

  • Patients have to be diagnosed with sarcoidosis based on consistent clinical features and BAL fluid analysis results, according to the WASOG guidelines.
  • The diagnosis IPF will be made based on the ATS guidelines

Exclusion Criteria:

  • Poor expression in the Dutch language
  • Relevant co morbidity such as a malignancy, dementia, and a history of psychiatric illness
  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: NCT00504621

Sponsors and Collaborators
Maastricht University Medical Center
University of Tilburg
Investigators
Study Chair: Marjolein Drent, Md, PhD Maastricht University
Study Chair: Jolanda de Vries, PhD Tilburg University
Principal Investigator: Marjon Elfferich, MSc Gelderse Vallei Ziekenhuis Ede
  More Information

Publications:
Responsible Party: Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT00504621     History of Changes
Other Study ID Numbers: MEC 07-4-015
Study First Received: July 19, 2007
Last Updated: March 25, 2014
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Maastricht University Medical Center:
personality
fatigue
quality of life
health care consumption

Additional relevant MeSH terms:
Fibrosis
Pulmonary Fibrosis
Sarcoidosis
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Lymphoproliferative Disorders
Lymphatic Diseases

ClinicalTrials.gov processed this record on August 19, 2014