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Moderate to severe fatigue in patients with interstitial lung disease (FAntasTIGUE-ILD)


- candidate number28838
- NTR NumberNTR7201
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR23-apr-2018
- Secondary IDsMETCZ20180027 
- Public TitleModerate to severe fatigue in patients with interstitial lung disease (FAntasTIGUE-ILD)
- Scientific TitleModerate to severe fatigue in patients with interstitial lung disease (FAntasTIGUE-ILD)
- ACRONYMILD-Fat
- hypothesisFatigue is expected to be the most prevalent symptom in patients with ILD (IPF and sarcoidosis), next to dyspnoea. Frequency of moderate to severe fatigue in patients with ILD is unknown. In addition, possible correlates of fatigue, including age, gender, body mass index, the degree of lung function impairment, dyspnoea, health status, symptoms of anxiety/depression, grief, sleepiness and catastrophizing thoughts will be evaluated.
- Healt Condition(s) or Problem(s) studiedFatigue, Lung disease, Sarcoidosis
- Inclusion criteriaClinically stable diagnosed pulmonary fibrosis or sarcoidosis (no exacerbation/hospitalization <4 weeks) from the outpatient clinic of the Department of Respiratory Medicine (Zuyderland Heerlen or Sittard)
- Exclusion criteriaA potential subject who meets any of the following criteria will be excluded from participation in this study:
1. Lack of sufficient understanding of the Dutch language;
2. Unable to complete questionnaires because of cognitive impairment;
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- Type2 or more arms, non-randomized
- Studytypeobservational
- planned startdate 1-mei-2018
- planned closingdate1-mei-2019
- Target number of participants150
- InterventionsA cross-sectional questionnaire study. In the current study no product, medicinal product, food product or medical device will be investigated.
- Primary outcomeFatigue, measured by the Cis-Fat (Attachment A), is the primary outcome. The Cis-Fat consists of eight items, scored on a 7-point Likert scale. The range of scores is from 8 (normal fatigue) to 56 (most severe fatigue), with a higher score indicating a higher level of fatigue. Scores 26 points indicate normal fatigue, scores 27 to 35 indicate moderate fatigue and scores 35 indicate severe fatigue
- Secondary outcomeDemographic data (as age, gender, lungfunction, medication, etc) and questionnaires (as mMRC, VAS, CAT, EQ-5D-5L, HADS, ADIQ, KWAMOE, FCS, PAM)
- TimepointsNot applicable
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIESMSc Ada E.M. Bloem
- CONTACT for SCIENTIFIC QUERIESMSc Ada E.M. Bloem
- Sponsor/Initiator
- Funding
(Source(s) of Monetary or Material Support)
- Publications
- Brief summaryPatients with interstitial lung disease (ILD; in this study limited to idiopathic pulmonary fibrosis or sarcoidosis) frequently report fatigue. Fatigue is expected to be the most prevalent symptom in patients with ILD, next to dyspnoea. This study is to determine the frequency of moderate to severe fatigue in patients with ILD (IPF and sarcoidosis)
- Main changes (audit trail)
- RECORD23-apr-2018 - 13-mei-2018


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