Chronic Obstructive Pulmonary Disease
Conditions
Keywords
COPD, emphysema, chronic bronchitis
Brief summary
The purpose of this randomized controlled trial is to evaluate the hypothesis that the 'written' action plan, a self-management tool developed by the project group, enhances early detection and prompt action measures and consequently isbeneficial in exacerbation outcome (i.e., health status recovery time).
Detailed description
Early detection of exacerbations by COPD patients initiating prompt interventions has shown to be clinically relevant. Until now, research failed to identify the effectiveness of a written individualized Action Plan (AP) to achieve this. The current multicenter, single-blind RCT with a follow-up period of 6 months, evaluates the hypothesis that individualized AP's reduce exacerbation recovery time. Patients are included from regular respiratory nurse visits and allocated to either usual care or an additional AP providing individualized treatment prescriptions (pharmaceutical and non-pharmaceutical) related to a colour coded symptom status (reinforcement at 1 and 4 months). Although usually not possible in self-management trials, we ensured blinding of patients, using a modified informed consent procedure in which patients give consent to postponed information. Exacerbations in both study arms are defined using the Anthonisen symptom diary-card algorithm. The Clinical COPD Questionnaire (CCQ) is assessed every 3-days. CCQ-recovery time of an exacerbation is our primary outcome. Additionally, healthcare utilisation, anxiety, depression, treatment delay, and self-efficacy are assessed at baseline, 6 and 12 months.
Interventions
BEHAVIORALAction plan
Individualized written Action Plan to enhance self-management and early detection of an exacerbation.
Sponsors
UMC Utrecht
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* post-bronchodilator forced expiratory volume in 1 second/forced vital capacity (FEV1/FVC) ratio \< 70% * age \> 40 years * complaints of chronic cough * smoking history of more than 20 years or 15 pack-years * diagnosis of COPD as major functionally limiting disease and * current use of bronchodilator therapy.
Exclusion criteria
* primary diagnosis of asthma * primary diagnosis of cardiac disease * presence of disease that could either effect mortality or participation in the study (e.g. confusional states).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| CCQ-recovery time in the event of an exacerbation(Health status recovery time) | 6-months |
Secondary
| Measure | Time frame |
|---|---|
| Health Related Quality of Life - St George Respiratory Questionnaire | baseline and 6 months follow-up |
| The Hospital Anxiety and Depression Scale (HADS) | baseline and 6 months follow-up |
| Medical Research Council (MRC) Dyspnoea Scale | baseline and 6 months follow-up |
| Symptom recovery time in the event of an exacerbation | 6 months |
| Contact delay & treatment delay in the event of an exacerbation | 6 months |
| Exacerbation rates (Number of symptom-based / event-based exacerbations per patient year) | 6 months |
| Healthcare Utilization (The number of respiratory-related hospital admissions, hospital days, emergency room visits and scheduled and unscheduled visits or telephone calls to a RP and GP) | 6 months |
| Julius Self-Efficacy Scale | baseline and 6 months follow-up |
Countries
Netherlands
Outcome results
None listed