Clinical trial NCT00879281: Action Plan to Enhance Self-management and Early Detection of Exacerbations in Chronic Obstructive Pulmonary Disease (COPD) Patients
Official title: Action Plan to Enhance Self-management and Early Detection of Exacerbations in COPD Patients; A Multicenter RCT (ACZiE)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: COPD
emphysema
chronic bronchitis
Lead sponsor: UMC Utrecht
Sponsor class: OTHER
First posted: 2009-04-09
Enrollment: 233
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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).

Primary outcomes:
measure: CCQ-recovery time in the event of an exacerbation(Health status recovery time)
timeFrame: 6-months
Secondary outcomes:
measure: Symptom recovery time in the event of an exacerbation
timeFrame: 6 months
measure: Health Related Quality of Life - St George Respiratory Questionnaire
timeFrame: baseline and 6 months follow-up
measure: The Hospital Anxiety and Depression Scale (HADS)
timeFrame: baseline and 6 months follow-up
measure: Medical Research Council (MRC) Dyspnoea Scale
timeFrame: baseline and 6 months follow-up
measure: Julius Self-Efficacy Scale
timeFrame: baseline and 6 months follow-up
measure: Contact delay & treatment delay in the event of an exacerbation
timeFrame: 6 months
measure: Exacerbation rates (Number of symptom-based / event-based exacerbations per patient year)
timeFrame: 6 months
measure: 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)
timeFrame: 6 months
Other outcomes:
Locations:
city: Utrecht
country: Netherlands
facility: Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht
Study officials:
affiliation: University Medical Center Utrecht, The Netherlands
name: Jaap C.A. Trappenburg, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: University Medical Center Utrecht, The Netherlands
name: Gerdien D. de Weert - van Oene, PhD
role: STUDY_CHAIR
affiliation: University Medical Center Utrecht, The Netherlands
name: Evelyn M. Monninkhof, PhD
role: STUDY_CHAIR
affiliation: KU Leuven
name: Thierry Troosters, PhD
role: STUDY_CHAIR
affiliation: McGill University, Montreal Chest Institute, Canada
name: Jean Bourbeau, PhD
role: STUDY_CHAIR
affiliation: University Medical Center Utrecht, The Netherlands
name: Theo J.M. Verheij, PhD
role: STUDY_DIRECTOR
affiliation: University Medical Center Utrecht, The Netherlands
name: Jan-Willem J. Lammers, PhD
role: STUDY_DIRECTOR
affiliation: University Medical Center Utrecht, The Netherlands
name: Guus J.P. Schrijvers, PhD
role: STUDY_DIRECTOR
References:
citation: Turnock AC, Walters EH, Walters JA, Wood-Baker R. Action plans for chronic obstructive pulmonary disease. Cochrane Database Syst Rev. 2005 Oct 19;(4):CD005074. doi: 10.1002/14651858.CD005074.pub2.
citation: Effing T, Monninkhof EM, van der Valk PD, van der Palen J, van Herwaarden CL, Partidge MR, Walters EH, Zielhuis GA. Self-management education for patients with chronic obstructive pulmonary disease. Cochrane Database Syst Rev. 2007 Oct 17;(4):CD002990. doi: 10.1002/14651858.CD002990.pub2.
citation: Trappenburg JC, Koevoets L, de Weert-van Oene GH, Monninkhof EM, Bourbeau J, Troosters T, Verheij TJ, Lammers JW, Schrijvers AJ. Action Plan to enhance self-management and early detection of exacerbations in COPD patients; a multicenter RCT. BMC Pulm Med. 2009 Dec 29;9:52. doi: 10.1186/1471-2466-9-52.