TY - JOUR
T1 - Fatigue in patients with chronic obstructive pulmonary disease
T2 - protocol of the Dutch multicentre, longitudinal, observational FAntasTIGUE study
AU - Goertz, Yvonne M. J.
AU - Looijmans, Milou
AU - Prins, Judith B.
AU - Janssen, Daisy J. A.
AU - Thong, Melissa S. Y.
AU - Peters, Jeannette B.
AU - Burtin, Chris
AU - Meertens-Kerris, Yvonne
AU - Coors, Arnold
AU - Muris, Jean W. M.
AU - Sprangers, Mirjam A. G.
AU - Wouters, Emiel F. M.
AU - Vercoulen, Jan H.
AU - Spruit, Martijn A.
PY - 2018/4
Y1 - 2018/4
N2 - Introduction Fatigue is the second most common symptom in patients with chronic obstructive pulmonary disease (COPD). Despite its high prevalence, fatigue is often ignored in daily practice. For this reason, little is known about the underlying determinants of fatigue in patients with COPD. The primary objectives of this study are to chart the course of fatigue in patients with COPD, to identify the physical, systemic, psychological and behavioural factors that precipitate and perpetuate fatigue in patients with COPD, to evaluate the impact of exacerbation-related hospitalisations on fatigue and to better understand the association between fatigue and 2-year all-cause hospitalisation and mortality in patients with COPD. The secondary aim is to identify diurnal differences in fatigue by using ecological momentary assessment (EMA). This manuscript describes the protocol of the FAntasTIGUE study and gives an overview of the possible strengths, weaknesses and clinical implications.Methods and analysis A 2-year longitudinal, observational study, enrolling 400 patients with clinically stable COPD has been designed. Fatigue, the primary outcome, will be measured by the subjective fatigue subscale of the Checklist Individual Strength (CIS-Fatigue). The secondary outcome is the day-to-day/diurnal fatigue, registered in a subsample (n=60) by EMA. CIS-Fatigue and EMA will be evaluated at baseline, and at 4, 8 and 12 months. The precipitating and perpetuating factors of fatigue (physical, psychological, behavioural and systemic) will be assessed at baseline and at 12 months. Additional assessments will be conducted following hospitalisation due to an exacerbation of COPD that occurs between baseline and 12 months. Finally, at 18 and 24 months the participants will be followed up on their fatigue, number of exacerbations, exacerbation-related hospitalisation and survival.Ethics and dissemination This protocol was approved by the Medical research Ethics Committees United, Nieuwegein, the Netherlands (NL60484.100.17).
AB - Introduction Fatigue is the second most common symptom in patients with chronic obstructive pulmonary disease (COPD). Despite its high prevalence, fatigue is often ignored in daily practice. For this reason, little is known about the underlying determinants of fatigue in patients with COPD. The primary objectives of this study are to chart the course of fatigue in patients with COPD, to identify the physical, systemic, psychological and behavioural factors that precipitate and perpetuate fatigue in patients with COPD, to evaluate the impact of exacerbation-related hospitalisations on fatigue and to better understand the association between fatigue and 2-year all-cause hospitalisation and mortality in patients with COPD. The secondary aim is to identify diurnal differences in fatigue by using ecological momentary assessment (EMA). This manuscript describes the protocol of the FAntasTIGUE study and gives an overview of the possible strengths, weaknesses and clinical implications.Methods and analysis A 2-year longitudinal, observational study, enrolling 400 patients with clinically stable COPD has been designed. Fatigue, the primary outcome, will be measured by the subjective fatigue subscale of the Checklist Individual Strength (CIS-Fatigue). The secondary outcome is the day-to-day/diurnal fatigue, registered in a subsample (n=60) by EMA. CIS-Fatigue and EMA will be evaluated at baseline, and at 4, 8 and 12 months. The precipitating and perpetuating factors of fatigue (physical, psychological, behavioural and systemic) will be assessed at baseline and at 12 months. Additional assessments will be conducted following hospitalisation due to an exacerbation of COPD that occurs between baseline and 12 months. Finally, at 18 and 24 months the participants will be followed up on their fatigue, number of exacerbations, exacerbation-related hospitalisation and survival.Ethics and dissemination This protocol was approved by the Medical research Ethics Committees United, Nieuwegein, the Netherlands (NL60484.100.17).
KW - BREAST-CANCER PATIENTS
KW - HEALTH-STATUS
KW - SUBJECTIVE FATIGUE
KW - PHYSICAL-ACTIVITY
KW - SHORT-FORM
KW - COPD
KW - VALIDATION
KW - VALIDITY
KW - DYSPNEA
KW - SCALE
U2 - 10.1136/bmjopen-2018-021745
DO - 10.1136/bmjopen-2018-021745
M3 - Article
C2 - 29643168
SN - 2044-6055
VL - 8
JO - BMJ Open
JF - BMJ Open
IS - 4
M1 - 021745
ER -