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…
ID
Source
Brief title
Condition
- Bronchial disorders (excl neoplasms)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome, fatigue, will be measured by the subscale subjective
fatigue of the Checklist Individual Strength (Cis-Fat) (8 items, 7-point Likert
scale). Patients will be asked to fill out this questionnaire at baseline, and
at months 4, 8, 12, 18 and 24, and during non-elective hospitalizations.
Secondary outcome
Nijmegen and Maastricht:
Day-to-day/diurnal fatigue (Ecological Momentary Assessment (EMA)) (Sub sample,
n= 60).
Socio-demographic factors:
- Gender;
- Age;
- Social-economic status (SES);
- Marital status;
- Survival status.
Physiological factors:
- Body mass index (BMI);
- Activity-related dyspnoea (modified Medical Research Council dyspnoea grade
(mMRC));
- Symptoms checklist (Visual Analogue Scale (VAS));
- Lower-limb muscle function (MicroFET2 hand-held dynamometer);
- History of COPD-related exacerbations and hospitalizations in the previous
year;
- Current pulmonary and non-pulmonary medication;
- Self-reported comorbidities (Charlson Comorbidity Index (CCI);
- Waist circumference;
- Peripheral artery disease (Huntleigh D900 Doppler 8Mhz probe);
- Mobility (Short Physical Performance Battery (SPPB));
- Handgrip muscle strength (JAMAR);
- Functional exercise capacity (two times a 6 Minute Walking Test (6MWT),
combined with continuous monitoring of a patients* SpO2 and heart rate by the
use of a pulse oximeter);
- A Bioelectrical Impedance Analysis (BIA);
- A lung function.
Psychological factors:
- Disease specific and generic health-status (Nijmegen Clinical Screening
Instrument (NCSI));
- COPD status (COPD Assessment Test (CAT));
- Generic health status (EQOL-5D-5L (EQ-5D-5L));
- Symptoms of anxiety and depression (Hospital Anxiety Depression Scale (HADS));
- Cognitive status (Montreal Cognitive Assessment (MOCA));
- Grief (Acceptance of Disease and Impairments Questionnaire (ADIQ));
- Qualitative experience of fatigue (KWAMOE);
- Fatigue-related self-efficacy (Self-Efficacy-5);
- Catastrophizing (Jacobsen Fatigue Catastrophizing Scale);
- Fear of progression (Fear Of Progression Questionnaire);
- Activity Cognitions Instrument (ACI);
- Patient Activation Measure (PAM).
Behavioural factors:
- Smoking status;
- Alcohol consumption;
- Caffeine consumption;
- Objectified physical activity (ActiGraph GT3X, 3-axis activity monitor,
3.8x3.7x1.8cm);
- Sleep quality (Pittsburgh Sleep Quality Index (PSQI) en accelerometer);
- Drowsiness (Epworth Sleepiness Scale (ESS));
- Attributions (Causal Attribution List (CAL));
- Social impairments (Sickness Impact Profile (SIP));
- Social support (Social Support List, Interactions and Discrepancies (SSL-I,
SSL-D)).
Systemic factors:
- Venous blood sampling (hs-CRP, IL-6, TNF-alfa, IL-1-alfa, IL-1-beta, IL-1-RN,
IL-10, fibrinogen, leukocytes, cortisol, haemoglobin, glucose, thyroid function
(TSH), renal function (creatinine), sodium, Potassium, calcium, magnesium,
vitamine B12, vitamine 25(OH)D3, liver function (ASAT and ALAT), NT-pro-BNP,
blood sediment, ANA and DNA).
Additional tests for patients from the Maastricht region:
- A resting cardiac echocardiography;
- A resting electrocardiogram;
- Retinal imaging to assess retinal microcirculation.
Background summary
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 it
is thought to be caused by a cascade of events. Currently, the underlying
causes of fatigue in COPD have been studied scarcely.
Study objective
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.
Study design
A two-year longitudinal, observational study has been designed. 260 patients
with clinically stable COPD (GOLD A to D, no exacerbation/hospitalization <4
weeks) will be recruited at the outpatient clinic of the Departments of
Respiratory Medicine in Maastricht and the Department of Pulmonary diseases in
Nijmegen, and from the RNFM, ZIO and nHP. In addition, patients who
participated in the Chance Study (recruitment period 2012-2015, METC MUMC+
11-3-070, NTR 3416), were recruited from primary or secondary care, and had
indicated on the Informed Consent that they may be approached for follow-up
research were invited to take part in the FAntasTIGUE study. Primary, secondary
and explanatory outcomes will be assessed at various time points.
The primary outcome, fatigue, will be measured by the subscale subjective
fatigue of the Checklist Individual Strength (Cis-Fat) (8 items, 7-point Likert
scale). Patients will be asked to fill out this questionnaire at baseline, and
at months 4, 8, 12, 18 and 24, as well as during non-elective hospitalizations
and two weeks after discharge.
The secondary outcome is the day-to-day/diurnal variations of fatigue as
measured in a subsample (n=60) with Ecological Momentary Assessment (EMA). EMA
will be registered at baseline, and month 4, 8 and 12.
Other, explanatory outcomes are physical-, systemic-, psychological and
behavioural factors (the precipitating and perpetuating factors of fatigue)
that will be measured at baseline and at month 12. 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 hospitalization, and two weeks
after discharge.
Finally, at month 18 and 24 (6 months and 1 year after completion of the study)
fatigue, number of exacerbations, exacerbation-related hospitalizations, and
survival will be assessed.
Study burden and risks
There are no serious risks associated with participation in this study. The
only minor injury that can occur is a hematoma from the venous blood sampling,
which will heal within a few days. Besides the hematoma, patients may
experience muscle fatigue and shortness of breath while performing the six
minute walk tests. We will compensate for this by giving the patient sufficient
time to rest before and after the exercise. At last, participation requires
time investment (approximately 7 hours in total for the whole study).
Hornerheide 1
Haelen 6085NM
NL
Hornerheide 1
Haelen 6085NM
NL
Listed location countries
Age
Inclusion criteria
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), may not use oral corticosteroids
and/or antibiotics for an acute exacerbation/infection and/or has an
exacerbation-related hospitalization less than 4 weeks before enrolment, and
must provide written informed consent.
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;
3. Participating in other interventionstudies.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL60484.100.17 |
| OMON | NL-OMON23962 |