Clinical trial NCT00504621: The Influence of Personality on Pulmonary Fibrosis and Sarcoidosis
Official title: The Influence of Personality on Quality of Life, Fatigue, Prognosis, and Health Care Consumption in Pulmonary Fibrosis and Sarcoidosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sarcoidosis
Pulmonary Fibrosis
Keywords: personality
fatigue
quality of life
health care consumption
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
Collaborators: name: Tilburg University
First posted: 2007-07-20
Enrollment: 450
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Sarcoidosis patients diagnosed according to WASOG guidelines and IPF patients diagnosed according ATS guidelines.

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.


Eligibility 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

Primary outcomes:
measure: The role of personality factors as predictors in sarcoidosis and pulmonary fibrosis.
timeFrame: 18 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Maastricht University
name: Marjolein Drent, Md, PhD
role: STUDY_CHAIR
affiliation: Tilburg University
name: Jolanda de Vries, PhD
role: STUDY_CHAIR
affiliation: Gelderse Vallei Ziekenhuis Ede
name: Marjon Elfferich, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Elfferich MD, De Vries J, Drent M. Type D or 'distressed' personality in sarcoidosis and idiopathic pulmonary fibrosis. Sarcoidosis Vasc Diffuse Lung Dis. 2011 Jul;28(1):65-71.