Fatigue in patients with chronic obstructive pulmonary disease: protocol of the Dutch multicentre, longitudinal, observational FAntasTIGUE study
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 prim...
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BMJ Publishing Group
2018-04-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/8/4/e021745.full |
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| author | Mirjam A G Sprangers Martijn A Spruit Emiel F M Wouters Daisy J A Janssen Jean W M Muris Judith B Prins Yvonne M J Goërtz Milou Looijmans Melissa S Y Thong Jeannette B Peters Chris Burtin Yvonne Meertens-Kerris Arnold Coors Jan H Vercoulen |
| author_facet | Mirjam A G Sprangers Martijn A Spruit Emiel F M Wouters Daisy J A Janssen Jean W M Muris Judith B Prins Yvonne M J Goërtz Milou Looijmans Melissa S Y Thong Jeannette B Peters Chris Burtin Yvonne Meertens-Kerris Arnold Coors Jan H Vercoulen |
| author_sort | Mirjam A G Sprangers |
| collection | DOAJ |
| description | 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).Trial registration number NTR6933; Pre-results. |
| format | Article |
| id | doaj-art-470177c702504c24a3de4604d3b3f49f |
| institution | Kabale University |
| issn | 2044-6055 |
| language | English |
| publishDate | 2018-04-01 |
| publisher | BMJ Publishing Group |
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| series | BMJ Open |
| spelling | doaj-art-470177c702504c24a3de4604d3b3f49f2025-02-01T19:15:10ZengBMJ Publishing GroupBMJ Open2044-60552018-04-018410.1136/bmjopen-2018-021745Fatigue in patients with chronic obstructive pulmonary disease: protocol of the Dutch multicentre, longitudinal, observational FAntasTIGUE studyMirjam A G Sprangers0Martijn A Spruit1Emiel F M Wouters2Daisy J A Janssen3Jean W M Muris4Judith B Prins5Yvonne M J Goërtz6Milou Looijmans7Melissa S Y Thong8Jeannette B Peters9Chris Burtin10Yvonne Meertens-Kerris11Arnold Coors12Jan H Vercoulen134 Department of Medical Psychology, Academic Medical Centre University of Amsterdam, Amsterdam Public Health Research Institute, Amsterdam, The NetherlandsDepartment of Research and Development, Ciro, Horn, the Netherlands6 Ludwig Boltzmann Institute for Lung Health, Vienna, AustriaDepartment of Health Services Research, Faculty of Health, Medicine and Life Sciences, Maastricht University, Maastricht, the NetherlandsFamily Medicine, Maastricht University, Research Institute CAPHRI, Maastricht, Limburg, The NetherlandsMedical Psychology, Radboud Institute for Health Sciences, Radboud university medical center, Nijmegen, The Netherlands1 Department of Research and Education, Ciro, Centre of Expertise for Chronic Organ Failure, Horn, The Netherlands2 Department of Medical Psychology and Department of Pulmonary Diseases, Radboud University Nijmegen Medical Centre, Nijmegen, The Netherlands4 Department of Medical Psychology, Academic Medical Centre University of Amsterdam, Amsterdam Public Health Research Institute, Amsterdam, The Netherlands2 Department of Medical Psychology and Department of Pulmonary Diseases, Radboud University Nijmegen Medical Centre, Nijmegen, The NetherlandsREVAL—Rehabilitation Research Center, Faculty of Rehabilitation Sciences, BIOMED Biomedical Research Institute, Hasselt University, Hasselt, Belgium6 Patient Advisory Board, Ciro, Centre of Expertise for Chronic Organ Failure, Horn, The Netherlands7 Patient Advisory Board, Radboud University Nijmegen Medical Centre, Nijmegen, The Netherlands2 Department of Medical Psychology and Department of Pulmonary Diseases, Radboud University Nijmegen Medical Centre, Nijmegen, The NetherlandsIntroduction 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).Trial registration number NTR6933; Pre-results.https://bmjopen.bmj.com/content/8/4/e021745.full |
| spellingShingle | Mirjam A G Sprangers Martijn A Spruit Emiel F M Wouters Daisy J A Janssen Jean W M Muris Judith B Prins Yvonne M J Goërtz Milou Looijmans Melissa S Y Thong Jeannette B Peters Chris Burtin Yvonne Meertens-Kerris Arnold Coors Jan H Vercoulen Fatigue in patients with chronic obstructive pulmonary disease: protocol of the Dutch multicentre, longitudinal, observational FAntasTIGUE study BMJ Open |
| title | Fatigue in patients with chronic obstructive pulmonary disease: protocol of the Dutch multicentre, longitudinal, observational FAntasTIGUE study |
| title_full | Fatigue in patients with chronic obstructive pulmonary disease: protocol of the Dutch multicentre, longitudinal, observational FAntasTIGUE study |
| title_fullStr | Fatigue in patients with chronic obstructive pulmonary disease: protocol of the Dutch multicentre, longitudinal, observational FAntasTIGUE study |
| title_full_unstemmed | Fatigue in patients with chronic obstructive pulmonary disease: protocol of the Dutch multicentre, longitudinal, observational FAntasTIGUE study |
| title_short | Fatigue in patients with chronic obstructive pulmonary disease: protocol of the Dutch multicentre, longitudinal, observational FAntasTIGUE study |
| title_sort | fatigue in patients with chronic obstructive pulmonary disease protocol of the dutch multicentre longitudinal observational fantastigue study |
| url | https://bmjopen.bmj.com/content/8/4/e021745.full |
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