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

NCT00879281 | Completed DMC

• 1 other identifier: OND1333118
• Study Type: interventional
• Target: 233
• Locations: 1 country
• Sites: 1

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).

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

COPD; emphysema; chronic bronchitis

Outcome Measures

Primary Outcomes (1)

• CCQ-recovery time in the event of an exacerbation(Health status recovery time)

  6-months

Secondary Outcomes (8)

• Symptom recovery time in the event of an exacerbation

  6 months

• Health Related Quality of Life - St George Respiratory Questionnaire

  baseline and 6 months follow-up

• The Hospital Anxiety and Depression Scale (HADS)

  baseline and 6 months follow-up

• Medical Research Council (MRC) Dyspnoea Scale

  baseline and 6 months follow-up

• Julius Self-Efficacy Scale

  baseline and 6 months follow-up

Study Arms (2)

1 Care as usual

NO INTERVENTION

Regular care

2 Intervention

EXPERIMENTAL

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

Behavioral: Action plan

Interventions

Action plan BEHAVIORAL

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

2 Intervention

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• UMC Utrecht: lead

Study Sites (1)

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

Utrecht, Utrecht, 3584 CX, Netherlands

Location

Related Publications (3)

• 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.

  PMID: 16235392 BACKGROUND

• 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.

  PMID: 17943778 BACKGROUND

• 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.

  PMID: 20040088 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Emphysema; Bronchitis, Chronic

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Bronchitis; Respiratory Tract Infections; Infections; Bronchial Diseases

Study Officials

• Jaap C.A. Trappenburg, MSc

  University Medical Center Utrecht, The Netherlands

  PRINCIPAL INVESTIGATOR

• 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

  KU Leuven

  STUDY CHAIR

• Jean Bourbeau, PhD

  McGill University, Montreal Chest Institute, Canada

  STUDY CHAIR

• 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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 8, 2009
• First Posted: April 9, 2009
• Study Start: December 1, 2008
• Primary Completion: September 1, 2010
• Study Completion: December 1, 2010
• Last Updated: February 24, 2011

Record last verified: 2009-04

Locations

NL (1)