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

NCT ID: NCT00879281

Last Updated: 2011-02-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 233 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-12-31
• Study Completion Date: 2010-12-31

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.

Conditions

Chronic Obstructive Pulmonary Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

1 Care as usual

Regular care

Group Type: NO_INTERVENTION

No interventions assigned to this group

2 Intervention

Regular Care + individualized "written" action plan to enhance self-mananagement and early detection/treatment of an exacerbation.

Group Type: EXPERIMENTAL

Action plan

Intervention Type: BEHAVIORAL

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

Interventions

Action plan

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

Intervention Type: BEHAVIORAL

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).

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

UMC Utrecht

OTHER

Sponsor Role: lead

Responsible Party

Julius Center for Health Sciences and Primary Care

Principal Investigators

Jaap C.A. Trappenburg, MSc

Role: PRINCIPAL_INVESTIGATOR

University Medical Center Utrecht, The Netherlands

Gerdien D. de Weert - van Oene, PhD

Role: STUDY_CHAIR

University Medical Center Utrecht, The Netherlands

Evelyn M. Monninkhof, PhD

Role: STUDY_CHAIR

University Medical Center Utrecht, The Netherlands

Thierry Troosters, PhD

Role: STUDY_CHAIR

KU Leuven

Jean Bourbeau, PhD

Role: STUDY_CHAIR

McGill University, Montreal Chest Institute, Canada

Theo J.M. Verheij, PhD

Role: STUDY_DIRECTOR

University Medical Center Utrecht, The Netherlands

Jan-Willem J. Lammers, PhD

Role: STUDY_DIRECTOR

University Medical Center Utrecht, The Netherlands

Guus J.P. Schrijvers, PhD

Role: STUDY_DIRECTOR

University Medical Center Utrecht, The Netherlands

Locations

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

Utrecht, Utrecht, Netherlands

Countries

Netherlands

References

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.

Reference Type: BACKGROUND

PMID: 16235392 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 17943778 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 20040088 (View on PubMed)

Other Identifiers

OND1333118

Identifier Type: -

Identifier Source: org_study_id