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The Influence of Personality on Pulmonary Fibrosis and Sarcoidosis

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ClinicalTrials.gov Identifier: NCT00504621
Recruitment Status : Completed
First Posted : July 20, 2007
Last Update Posted : March 26, 2014
Sponsor:
Collaborator:
Tilburg University
Information provided by (Responsible Party):
Maastricht University Medical Center

Study Description
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Brief Summary:
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 or disease
Sarcoidosis Pulmonary Fibrosis

Study Design
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Study Type : Observational
Actual Enrollment : 450 participants
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
Study Start Date : August 2007
Actual Primary Completion Date : October 2008
Actual Study Completion Date : January 2009

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
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


Outcome Measures
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Primary Outcome Measures :
  1. The role of personality factors as predictors in sarcoidosis and pulmonary fibrosis. [ Time Frame: 18 months ]
    The role of personality factors as predictors of fatigue, quality of life, prognosis, and health care consumption in sarcoidosis and pulmonary fibrosis.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00504621


Sponsors and Collaborators
Maastricht University Medical Center
Tilburg University
Investigators
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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
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Publications of Results:

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Responsible Party: Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT00504621    
Other Study ID Numbers: MEC 07-4-015
First Posted: July 20, 2007    Key Record Dates
Last Update Posted: March 26, 2014
Last Verified: March 2014
Keywords provided by Maastricht University Medical Center:
personality
fatigue
quality of life
health care consumption
Additional relevant MeSH terms:
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Pulmonary Fibrosis
Sarcoidosis
Fibrosis
Pathologic Processes
 Lung Diseases
Respiratory Tract Diseases
Lymphoproliferative Disorders
Lymphatic Diseases