The Influence of Personality on Pulmonary Fibrosis and Sarcoidosis

Sarcoidosis Clinical Trial

Official title:

The Influence of Personality on Quality of Life, Fatigue, Prognosis, and Health Care Consumption in Pulmonary Fibrosis and Sarcoidosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00504621
• Other study ID #: MEC 07-4-015
• Status: Completed
• Phase: N/A
• First received: July 19, 2007
• Last updated: March 25, 2014
• Start date: August 2007
• Est. completion date: January 2009

Study information

• Verified date: March 2014
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 450
• Est. completion date: January 2009
• Est. primary completion date: October 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Fibrosis
• Pulmonary Fibrosis
• Sarcoidosis

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Maastricht University Medical Center	University of Tilburg

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The role of personality factors as predictors in sarcoidosis and pulmonary fibrosis.	The role of personality factors as predictors of fatigue, quality of life, prognosis, and health care consumption in sarcoidosis and pulmonary fibrosis.	18 months	No