SarcoidosisNCT00504621
The Influence of Personality on Pulmonary Fibrosis and Sarcoidosis
An observational study of Sarcoidosis and Pulmonary Fibrosis, run by Maastricht University Medical Center.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sarcoidosis, Pulmonary Fibrosis
- How many people
- 450 participants
- Where
- No sites listed yet
- Study dates
- Aug 2007to Jan 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Sarcoidosis patients diagnosed according to WASOG guidelines and IPF patients diagnosed according ATS guidelines.
Who may be able to join
- 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
Who cannot join
- Poor expression in the Dutch language
- Relevant co morbidity such as a malignancy, dementia, and a history of psychiatric illness
About this study
Official title: The Influence of Personality on Quality of Life, Fatigue, Prognosis, and Health Care Consumption in Pulmonary Fibrosis and Sarcoidosis
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.
- Conditions
- Sarcoidosis, Pulmonary Fibrosis
- Keywords
- personality, fatigue, quality of life, health care consumption
- Medical subject headings
- Sarcoidosis, Pulmonary Fibrosis, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2007 (estimated)
- Study startAug 2007
- Primary completionOct 2008
- Study completionJan 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SarcoidosisStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Cross-sectional
- Enrolment
- 450 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Tilburg University
- Responsible party
- Sponsor
- Investigators
- Marjolein Drent, Md, PhD, Study chair, Maastricht UniversityJolanda de Vries, PhD, Study chair, Tilburg UniversityMarjon Elfferich, MSc, Principal investigator, Gelderse Vallei Ziekenhuis Ede
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00504621
- Sponsor's protocol ID
- MEC 07-4-015
- Status last verified
- Mar 2014
- First submitted
- 19 Jul 2007
- Last updated
- 26 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 21796893
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Personality on Quality of Life, Fatigue, Prognosis, and Health Care Consumption in Pulmonary Fibrosis and Sarcoidosis
- ClinicalTrials.gov ID
- NCT00504621
- Acronym / sponsor ID
- MEC 07-4-015
- Conditions
- Sarcoidosis, Pulmonary Fibrosis
- Keywords
- personality, fatigue, quality of life, health care consumption
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 450 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Collaborators
- Tilburg University
- Study start
- Aug 2007
- Primary completion
- Oct 2008 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 20 Jul 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Sarcoidosis patients diagnosed according to WASOG guidelines and IPF patients diagnosed according ATS guidelines.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- Poor expression in the Dutch language
- Relevant co morbidity such as a malignancy, dementia, and a history of psychiatric illness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2014.
- Results publication: PubMed 21796893Elfferich 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marjolein Drent, Md, PhD study chair
Maastricht University
Jolanda de Vries, PhD study chair
Tilburg University
Marjon Elfferich, MSc principal investigator
Gelderse Vallei Ziekenhuis Ede
Questions about this trial
What is this clinical trial studying?
An observational study of Sarcoidosis and Pulmonary Fibrosis, run by Maastricht University Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The role of personality factors as predictors in sarcoidosis and pulmonary fibrosis. (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00504621, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2014.