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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Action Plan to Enhance Self-management and Early Detection of Exacerbations in COPD Patients; A Multicenter RCT (ACZiE)

Conditions
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Chronic Obstructive Pulmonary Disease

Intervention / Treatment
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* Behavioral: Action plan


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: 1 Care as usual<br>Regular care | |
| Experimental: 2 Intervention<br>Regular Care + individualized written action plan to enhance self-mananagement and early detection/treatment of an exacerbation. | Behavioral: Action plan<br>* Individualized written Action Plan to enhance self-management and early detection of an exacerbation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CCQ-recovery time in the event of an exacerbation(Health status recovery time) |  | 6-months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptom recovery time in the event of an exacerbation |  | 6 months | 
| 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 | 
| Julius Self-Efficacy Scale |  | baseline and 6 months follow-up | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COPD, emphysema, chronic bronchitis