Lung disease pulmonary disease
Conditions
Interventions
None listed
Sponsors
CIRO
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
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
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 outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 acti | — |
Countries
Netherlands
Outcome results
None listed