Fatigue is increased in patients with COPD compared to healthy elderly. Moderate to severe fatigue occurs frequently in clinically stable COPD (30-70%), and fatigue is next to dyspnoea the most dominant symptom in COPD. So, fatigue is a common,…
ID
Bron
Verkorte titel
Aandoening
Patients with Chronic Obstructive Pulmonary Disease (COPD); fatigue; underlying factors.
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Fatigue severity, measured by the subjective fatigue subscale of the Checklist Individual Strength (CIS-Fatigue).
Achtergrond van het onderzoek
Fatigue is increased in patients with COPD compared to healthy elderly. Moderate to severe fatigue occurs frequently in clinically stable COPD (30-70%), and fatigue is next to dyspnoea the most dominant symptom in COPD. So, fatigue is a common distressing symptom in patients with COPD but goes often undiagnosed and untreated. The pathobiology of fatigue is complex and is thought to be caused by a cascade of events. Currently, the underlying causes of fatigue in COPD have been studied scarcely. To identify physical, systemic, psychological, and behavioural factors that precipitate and/or perpetuate fatigue in patients with clinically stable COPD and to identify the impact of exacerbation-related hospitalizations on fatigue and its perpetuating factors. Thirdly, to better understand the association between fatigue and 2-year all-cause hospitalization and mortality in patients with COPD.
Doel van het onderzoek
Fatigue is increased in patients with COPD compared to healthy elderly. Moderate to severe fatigue occurs frequently in clinically stable COPD (30-70%), and fatigue is next to dyspnoea the most dominant symptom in COPD. So, fatigue is a common, distressing symptom in COPD patients, and goes often undiagnosed and untreated. The pathobiology of fatigue is complex and is thought to be caused by a cascade of events. Currently, the underlying causes of fatigue have been studied scarcely in COPD.
The primary objectives of the FAntasTIGUE study are: (1) To chart the course of fatigue in patients with COPD; (2) To identify physical, systemic, psychological, and behavioural factors that precipitate and/or perpetuate fatigue in patients with COPD; (3) To identify the impact of exacerbation-related hospitalizations on fatigue and its perpetuating factors; (4) To better understand the association between baseline fatigue and 2-year all-cause hospitalization and mortality in patients with COPD.
The secondary objective of this study is: To identify diurnal differences in fatigue by augmenting traditional questionnaire data with Ecological Momentary Assessment (EMA).
Onderzoeksopzet
The assessments at baseline, 12 months, and during the first days of a possible exacerbation-related hospitalization will be performed in a hospital setting. The remaining measurements at 4, 8, 18, and 24 months will take place at the patients’ homes.
The primary outcome fatigue severity will be assessed at baseline, and at 4, 8, 12, 18 and 24 months, as well as during exacerbation-related hospitalizations and two weeks after discharge. The secondary outcome, day-to-day/diurnal variation in fatigue, will be registered at baseline, and at 4, 8 and 12 months. The precipitating and perpetuating factors of moderate to severe fatigue in patients with COPD (physical, psychological, behavioural, and systemic factors), will be assessed at baseline and at 12 months. Also, when patients are admitted to the hospital between baseline and 12 months due to an exacerbation of COPD, some tests will be repeated during the first days of hospitalization, and two weeks after discharge. At last, at 18 and 24 months the participants will be followed-up on their fatigue, number of exacerbations, exacerbation-related hospitalization and survival.
Onderzoeksproduct en/of interventie
Observational study to investigate the underlying factors of moderate to severe fatigue in patients with Chronic Obstructive Pulmonary Disease (COPD).
Algemeen / deelnemers
CIRO+, centre of expertise for chronic organ failure<br>
Hornerheide 1
Martijn A. Spruit
Horn 6085 NM
The Netherlands
+31 (0)475 587726
martijnspruit@ciro-horn.nl
Wetenschappers
CIRO+, centre of expertise for chronic organ failure<br>
Hornerheide 1
Martijn A. Spruit
Horn 6085 NM
The Netherlands
+31 (0)475 587726
martijnspruit@ciro-horn.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
In order to be eligible to participate in this study, a subject must be diagnosed with COPD according to the Global Strategy for the Diagnosis, Management, and Prevention of COPD (GOLD), no use of oral corticosteroids and/or antibiotics; and/or has no exacerbation-related hospitalization less than 4 weeks before enrolment, and must provide written informed consent.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
Patients lacking a sufficient understanding of the Dutch language and/or participating in concurrent intervention studies will be excluded.
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
Register | ID |
---|---|
NTR-new | NL6722 |
NTR-old | NTR6933 |
CCMO | NL60484.100.17 |
OMON | NL-OMON53067 |