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

Purpose

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).

Condition	Intervention
Chronic Obstructive Pulmonary Disease	Behavioral: Action plan


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment
Official Title:	Action Plan to Enhance Self-management and Early Detection of Exacerbations in COPD Patients; A Multicenter RCT (ACZiE)

Resource links provided by NLM:

MedlinePlus related topics: COPD

U.S. FDA Resources

Further study details as provided by UMC Utrecht:

Primary Outcome Measures:

CCQ-recovery time in the event of an exacerbation(Health status recovery time) [ Time Frame: 6-months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Symptom recovery time in the event of an exacerbation [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Health Related Quality of Life - St George Respiratory Questionnaire [ Time Frame: baseline and 6 months follow-up ] [ Designated as safety issue: No ]
The Hospital Anxiety and Depression Scale (HADS) [ Time Frame: baseline and 6 months follow-up ] [ Designated as safety issue: No ]
Medical Research Council (MRC) Dyspnoea Scale [ Time Frame: baseline and 6 months follow-up ] [ Designated as safety issue: No ]
Julius Self-Efficacy Scale [ Time Frame: baseline and 6 months follow-up ] [ Designated as safety issue: No ]
Contact delay & treatment delay in the event of an exacerbation [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Exacerbation rates (Number of symptom-based / event-based exacerbations per patient year) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]


Enrollment:	233
Study Start Date:	December 2008
Study Completion Date:	December 2010
Primary Completion Date:	September 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
No Intervention: 1 Care as usual Regular care
Experimental: 2 Intervention Regular Care + individualized "written" action plan to enhance self-mananagement and early detection/treatment of an exacerbation.	Behavioral: Action plan Individualized "written" Action Plan to enhance self-management and early detection of an exacerbation.

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


Ages Eligible for Study:	40 Years and older (Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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).

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00879281

Locations


Netherlands
Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht
Utrecht, Netherlands, 3584 CX

Sponsors and Collaborators

UMC Utrecht

Investigators


Principal Investigator:	Jaap C.A. Trappenburg, MSc	University Medical Center Utrecht, The Netherlands
Study Chair:	Gerdien D. de Weert - van Oene, PhD	University Medical Center Utrecht, The Netherlands
Study Chair:	Evelyn M. Monninkhof, PhD	University Medical Center Utrecht, The Netherlands
Study Chair:	Thierry Troosters, PhD	Katholieke Universiteit Leuven
Study Chair:	Jean Bourbeau, PhD	McGill University, Montreal Chest Institute, Canada
Study Director:	Theo J.M. Verheij, PhD	University Medical Center Utrecht, The Netherlands
Study Director:	Jan-Willem J. Lammers, PhD	University Medical Center Utrecht, The Netherlands
Study Director:	Guus J.P. Schrijvers, PhD	University Medical Center Utrecht, The Netherlands

More Information

Publications:

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.

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.


Responsible Party:	A.J.P. Schrijvers, Julius Center for Health Sciences and Primary Care
ClinicalTrials.gov Identifier:	NCT00879281 History of Changes
Other Study ID Numbers:	OND1333118
Study First Received:	April 8, 2009
Last Updated:	February 23, 2011
Health Authority:	Netherlands: Medical Ethics Review Committee (METC) Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by UMC Utrecht:


COPD emphysema chronic bronchitis

Additional relevant MeSH terms:


Lung Diseases Lung Diseases, Obstructive Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

ClinicalTrials.gov processed this record on September 28, 2016

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