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

October 12, 2018 updated by: Brenda O'Neill, University of Ulster

Pulmonary Rehabilitation in COPD: the Development and Feasibility of an Education Package

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.

Study Overview

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.

Study Type

Interventional

Enrollment (Actual)

53

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Belfast, United Kingdom
        • Southern Eastern Health and Social Care Trust
      • Derry, United Kingdom
        • Western Health and Social Care Trust
    • Co ANtrim
      • Belfast, Co ANtrim, United Kingdom
        • Belfast Health and Social Care Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Living Well with COPD 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 Names:
  • LWWCOPD

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Understanding your COPD questionaire
Time Frame: 6 weeks
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).
6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Bristol COPD Knowledge Questionnaire (BCKQ)
Time Frame: 6 weeks
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).
6 weeks
Global questions
Time Frame: 6 weeks
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.
6 weeks
Qualitative data collection (patients' perspective)
Time Frame: 6 weeks
An evaluation questionnaire will be completed after each education session.
6 weeks
Qualitative data collection (health professional's perspective)
Time Frame: 6 weeks
An evaluation questionnaire will be completed after each education session.
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (ACTUAL)

October 1, 2010

Study Completion (ACTUAL)

October 1, 2010

Study Registration Dates

First Submitted

October 21, 2010

First Submitted That Met QC Criteria

October 21, 2010

First Posted (ESTIMATE)

October 22, 2010

Study Record Updates

Last Update Posted (ACTUAL)

October 15, 2018

Last Update Submitted That Met QC Criteria

October 12, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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