Action Plan to Enhance Self-management and Early Detection of Exacerbations in Chronic Obstructive Pulmonary Disease (COPD) Patients (ACZiE)

UMC Utrecht

Status

Completed

Conditions

Chronic Obstructive Pulmonary Disease

Treatments

Behavioral: Action plan

Study type

Interventional

Funder types

Other

Identifiers

NCT00879281

OND1333118

Details and patient eligibility

About

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).

Full 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.

Enrollment

233 patients

Sex

All

Ages

40+ years old

Volunteers

No Healthy Volunteers

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).