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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON21789
Enrollment
150
Registered
2018-04-23
Start date
2018-05-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fatigue, ILD, IPF, Sarcoidosis

Interventions

A cross-sectional questionnaire study. In the current study no product, medicinal product, food product or medical device will be investigated.

Sponsors

NON
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Clinically 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 criteria

Exclusion criteria: A 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;

Design outcomes

Primary

MeasureTime frame
Fatigue, 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 ¡Ü26 points indicate normal fatigue, scores 27 to 35 indicate moderate fatigue and scores ¡Ý35 indicate severe fatigue

Secondary

MeasureTime frame
Demographic data (as age, gender, lungfunction, medication, etc) and questionnaires (as mMRC, VAS, CAT, EQ-5D-5L, HADS, ADIQ, KWAMOE, FCS, PAM)

Contacts

Public ContactAda E.M. Bloem

Postbus 12011 3501 AA

aadje.bloem@hu.nl | www.hu.nl06 38763295

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)