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

Chronic Obstructive Pulmonary Disease Clinical Trial

— ACZiE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00879281
• Other study ID #: OND1333118
• Status: Completed
• Phase: N/A
• First received: April 8, 2009
• Last updated: February 23, 2011
• Start date: December 2008
• Est. completion date: December 2010

Study information

• Verified date: April 2009
• Source: UMC Utrecht
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 233
• Est. completion date: December 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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).

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Behavioral:
• Action plan
Individualized "written" Action Plan to enhance self-management and early detection of an exacerbation.

Locations

Country	Name	City	State
Netherlands	Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht	Utrecht

Sponsors (1)

Lead Sponsor	Collaborator
UMC Utrecht

Country where clinical trial is conducted

Netherlands, 

References & Publications (2)

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. Review. Update in: Cochrane Database Syst Rev. 2014;3:CD002990. — View 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. Review. Update in: Cochrane Database Syst Rev. 2010;(5):CD005074. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CCQ-recovery time in the event of an exacerbation(Health status recovery time)		6-months	No
Secondary	Symptom recovery time in the event of an exacerbation		6 months	No
Secondary	Health Related Quality of Life - St George Respiratory Questionnaire		baseline and 6 months follow-up	No
Secondary	The Hospital Anxiety and Depression Scale (HADS)		baseline and 6 months follow-up	No
Secondary	Medical Research Council (MRC) Dyspnoea Scale		baseline and 6 months follow-up	No
Secondary	Julius Self-Efficacy Scale		baseline and 6 months follow-up	No
Secondary	Contact delay & treatment delay in the event of an exacerbation		6 months	No
Secondary	Exacerbation rates (Number of symptom-based / event-based exacerbations per patient year)		6 months	No
Secondary	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	No