Action Plan to Enhance Self-management and Early Detection of Exacerbations in Chronic Obstructive Pulmonary Disease (COPD) Patients (ACZiE)
Primary Purpose
Chronic Obstructive Pulmonary Disease
Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Action plan
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring COPD, emphysema, chronic bronchitis
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).
Sites / Locations
- Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
1 Care as usual
2 Intervention
Arm Description
Regular care
Regular Care + individualized "written" action plan to enhance self-mananagement and early detection/treatment of an exacerbation.
Outcomes
Primary Outcome Measures
CCQ-recovery time in the event of an exacerbation(Health status recovery time)
Secondary Outcome Measures
Symptom recovery time in the event of an exacerbation
Health Related Quality of Life - St George Respiratory Questionnaire
The Hospital Anxiety and Depression Scale (HADS)
Medical Research Council (MRC) Dyspnoea Scale
Julius Self-Efficacy Scale
Contact delay & treatment delay in the event of an exacerbation
Exacerbation rates (Number of symptom-based / event-based exacerbations per patient year)
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)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00879281
Brief Title
Action Plan to Enhance Self-management and Early Detection of Exacerbations in Chronic Obstructive Pulmonary Disease (COPD) Patients
Acronym
ACZiE
Official Title
Action Plan to Enhance Self-management and Early Detection of Exacerbations in COPD Patients; A Multicenter RCT (ACZiE)
Study Type
Interventional
2. Study Status
Record Verification Date
April 2009
Overall Recruitment Status
Completed
Study Start Date
December 2008 (undefined)
Primary Completion Date
September 2010 (Actual)
Study Completion Date
December 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
UMC Utrecht
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
Keywords
COPD, emphysema, chronic bronchitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
233 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1 Care as usual
Arm Type
No Intervention
Arm Description
Regular care
Arm Title
2 Intervention
Arm Type
Experimental
Arm Description
Regular Care + individualized "written" action plan to enhance self-mananagement and early detection/treatment of an exacerbation.
Intervention Type
Behavioral
Intervention Name(s)
Action plan
Intervention Description
Individualized "written" Action Plan to enhance self-management and early detection of an exacerbation.
Primary Outcome Measure Information:
Title
CCQ-recovery time in the event of an exacerbation(Health status recovery time)
Time Frame
6-months
Secondary Outcome Measure Information:
Title
Symptom recovery time in the event of an exacerbation
Time Frame
6 months
Title
Health Related Quality of Life - St George Respiratory Questionnaire
Time Frame
baseline and 6 months follow-up
Title
The Hospital Anxiety and Depression Scale (HADS)
Time Frame
baseline and 6 months follow-up
Title
Medical Research Council (MRC) Dyspnoea Scale
Time Frame
baseline and 6 months follow-up
Title
Julius Self-Efficacy Scale
Time Frame
baseline and 6 months follow-up
Title
Contact delay & treatment delay in the event of an exacerbation
Time Frame
6 months
Title
Exacerbation rates (Number of symptom-based / event-based exacerbations per patient year)
Time Frame
6 months
Title
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)
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jaap C.A. Trappenburg, MSc
Organizational Affiliation
University Medical Center Utrecht, The Netherlands
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Gerdien D. de Weert - van Oene, PhD
Organizational Affiliation
University Medical Center Utrecht, The Netherlands
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Evelyn M. Monninkhof, PhD
Organizational Affiliation
University Medical Center Utrecht, The Netherlands
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Thierry Troosters, PhD
Organizational Affiliation
KU Leuven
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Jean Bourbeau, PhD
Organizational Affiliation
McGill University, Montreal Chest Institute, Canada
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Theo J.M. Verheij, PhD
Organizational Affiliation
University Medical Center Utrecht, The Netherlands
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Jan-Willem J. Lammers, PhD
Organizational Affiliation
University Medical Center Utrecht, The Netherlands
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Guus J.P. Schrijvers, PhD
Organizational Affiliation
University Medical Center Utrecht, The Netherlands
Official's Role
Study Director
Facility Information:
Facility Name
Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht
City
Utrecht
ZIP/Postal Code
3584 CX
Country
Netherlands
12. IPD Sharing Statement
Citations:
PubMed Identifier
16235392
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.
Results Reference
background
PubMed Identifier
17943778
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.
Results Reference
background
PubMed Identifier
20040088
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.
Results Reference
derived
Learn more about this trial
Action Plan to Enhance Self-management and Early Detection of Exacerbations in Chronic Obstructive Pulmonary Disease (COPD) Patients
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