Pulmonary Rehabilitation in Chronic Obstructive Pulmonary Disease (COPD): the Development and Feasibility of an Education Package

This study has been completed.
Sponsor:
Collaborators:
McGill University Health Center
Belfast Health and Social Care Trust
South Eastern Health and Social Care Trust
Western Health and Social Care Trust
Information provided by (Responsible Party):
Brenda O'Neill, University of Ulster
ClinicalTrials.gov Identifier:
NCT01226836
First received: October 21, 2010
Last updated: November 8, 2012
Last verified: November 2012
  Purpose

The purpose of this study is to assess the feasibility and acceptability of the revised Living Well With COPD programme (LWWCOPD for Pulmonary Rehabilitation) when used to deliver the education component of pulmonary rehabilitation.


Condition Intervention
Chronic Obstructive Pulmonary Disease
Other: LWWCOPD for Pulmonary Rehabilitation

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pulmonary Rehabilitation in COPD: the Development and Feasibility of an Education Package

Resource links provided by NLM:


Further study details as provided by University of Ulster:

Primary Outcome Measures:
  • Understanding your COPD questionaire [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    The "Understanding your COPD" questionnaire will be used to assess knowledge, understanding and self-efficacy (pre- and post- pulmonary rehabilitation) and satisfaction with the education sessions (post- pulmonary rehabilitation only). This questionnaire is a self administered questionnaire which takes approximately 10 minutes to complete. It has been developed and assessed for reliability and responsiveness by our research team (Earley, O'Neill et al. 2008).


Secondary Outcome Measures:
  • The Bristol COPD Knowledge Questionnaire (BCKQ) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    The Bristol COPD Knowledge Questionnaire (BCKQ) will be used to assess knowledge pre- and post- pulmonary rehabilitation (White, Walker et al. 2006). The BCKQ is self-administered and takes 15 minutes to complete. It has been shown to be valid, reliable and responsive in patients with COPD (White, Walker et al 2006).

  • Global questions [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    The participants will answer three global questions post- pulmonary rehabilitation to assess their perception of the change in their knowledge levels since before the pulmonary rehabilitation programme. The global questions take 1 minute to complete.

  • Qualitative data collection (patients' perspective) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    An evaluation questionnaire will be completed after each education session.

  • Qualitative data collection (health professional's perspective) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    An evaluation questionnaire will be completed after each education session.


Enrollment: 53
Study Start Date: January 2010
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Living Well with COPD for Pulmonary Rehabilitation Other: LWWCOPD for Pulmonary Rehabilitation
As part of clinical care participants will attend a 6 week pulmonary rehabilitation programme consisting of supervised exercise and education sessions. The exercise component will be consistent with the usual pulmonary rehabilitation programme delivered at that site (BTS 2001, NICE 2004). The education sessions will be delivered using the revised LWWCOPD programme (1/week, approx. 30-45min). All health professionals will be provided with the health professionals' manual and supplementary posters for their respective education session. All participants will be provided with the revised LWWCOPD information booklet and an action plan for recognising and managing exacerbations.
Other Name: LWWCOPD

Detailed Description:

There is limited guidance on what should be included in the education component of pulmonary rehabilitation. International guidelines for COPD and pulmonary rehabilitation suggest numerous topics but do not provide specific information relating to the principal topics and how these should be delivered (BTS 2001, NICE 2004, ATS/ERS 2006). Recently this research team conducted focus groups of patients with COPD and established from their perspective the important education topics that should be covered in pulmonary rehabilitation, along with information on how these should be delivered (Wilson, O'Neill et al. 2008).

The Living Well with COPD (LWWCOPD) programme mostly includes these topics (Bourbeau, Julien et al. 2003). LWWCOPD, which is based on Bandura's self-efficacy theory, has been shown to significantly reduce healthcare utilisation and improve quality of life (Bourbeau, Julien et al. 2003, Bandura 1986). With modification and reformatting, the LWWCOPD programme could be delivered within the structure of pulmonary rehabilitation.

Although the LWWCOPD programme has been previously validated, it is important that the revised version is assessed for feasibility within the context of pulmonary rehabilitation. The practicality of delivering the programme and its acceptance by healthcare providers and patients should be assessed. Therefore, this study will involve a process evaluation to assess the feasibility and acceptability of using the revised LWWCOPD programme (LWWCOPD for Pulmonary Rehabilitation) to deliver the education component of pulmonary rehabilitation in Northern Ireland.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Participants

  • Clinical diagnosis of COPD.
  • Good understanding of written English in order to be able to provide accurate feedback on the patient information booklet and material used to facilitate the education sessions (as reported by the individual patient).
  • Eligible for pulmonary rehabilitation Health Professionals
  • Involved in the delivery of education sessions during pulmonary rehabilitation

Exclusion Criteria:

Participants

  • Unable to safely partake in pulmonary rehabilitation (e.g. unstable angina, some musculoskeletal conditions).
  • Unable to comprehend or follow instructions (e.g. dementia).
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01226836

Locations
United Kingdom
Belfast Health and Social Care Trust
Belfast, Co ANtrim, United Kingdom
Southern Eastern Health and Social Care Trust
Belfast, United Kingdom
Western Health and Social Care Trust
Derry, United Kingdom
Sponsors and Collaborators
University of Ulster
McGill University Health Center
Belfast Health and Social Care Trust
South Eastern Health and Social Care Trust
Western Health and Social Care Trust
Investigators
Principal Investigator: Brenda O'Neill, PhD University of Ulster
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Brenda O'Neill, Senior Lecturer, Physiotherapy, University of Ulster
ClinicalTrials.gov Identifier: NCT01226836     History of Changes
Other Study ID Numbers: 09/0152
Study First Received: October 21, 2010
Last Updated: November 8, 2012
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by University of Ulster:
Pulmonary Rehabilitation

Additional relevant MeSH terms:
Lung Diseases
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on August 26, 2014