NCT00504621

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
450

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2007

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 19, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 20, 2007

Completed
12 days until next milestone

Study Start

First participant enrolled

August 1, 2007

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2008

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2009

Completed
Last Updated

March 26, 2014

Status Verified

March 1, 2014

Enrollment Period

1.2 years

First QC Date

July 19, 2007

Last Update Submit

March 25, 2014

Conditions

Keywords

personalityfatiguequality of lifehealth care consumption

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

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 Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related 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.

MeSH Terms

Conditions

SarcoidosisPulmonary FibrosisFatigue

Condition Hierarchy (Ancestors)

Lymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesHypersensitivity, DelayedHypersensitivityImmune System DiseasesLung Diseases, InterstitialLung DiseasesRespiratory Tract DiseasesFibrosisPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and Symptoms

Study Officials

  • Marjolein Drent, Md, PhD

    Maastricht University

    STUDY CHAIR
  • Jolanda de Vries, PhD

    Tilburg University

    STUDY CHAIR
  • Marjon Elfferich, MSc

    Gelderse Vallei Ziekenhuis Ede

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 19, 2007

First Posted

July 20, 2007

Study Start

August 1, 2007

Primary Completion

October 1, 2008

Study Completion

January 1, 2009

Last Updated

March 26, 2014

Record last verified: 2014-03