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

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
LWWCOPD for Pulmonary Rehabilitation
Sponsored by
University of Ulster
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring Pulmonary Rehabilitation

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Belfast Health and Social Care Trust
  • Southern Eastern Health and Social Care Trust
  • Western Health and Social Care Trust

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Living Well with COPD for Pulmonary Rehabilitation

Arm Description

Outcomes

Primary Outcome Measures

Understanding your COPD questionaire
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)
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
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)
An evaluation questionnaire will be completed after each education session.
Qualitative data collection (health professional's perspective)
An evaluation questionnaire will be completed after each education session.

Full Information

First Posted
October 21, 2010
Last Updated
October 12, 2018
Sponsor
University of Ulster
Collaborators
McGill University Health Centre/Research Institute of the McGill University Health Centre, Belfast Health and Social Care Trust, South Eastern Health and Social Care Trust, Western Health and Social Care Trust
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1. Study Identification

Unique Protocol Identification Number
NCT01226836
Brief Title
Pulmonary Rehabilitation in Chronic Obstructive Pulmonary Disease (COPD): the Development and Feasibility of an Education Package
Official Title
Pulmonary Rehabilitation in COPD: the Development and Feasibility of an Education Package
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
October 2010 (Actual)
Study Completion Date
October 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Ulster
Collaborators
McGill University Health Centre/Research Institute of the McGill University Health Centre, Belfast Health and Social Care Trust, South Eastern Health and Social Care Trust, Western Health and Social Care Trust

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
Keywords
Pulmonary Rehabilitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
53 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Living Well with COPD for Pulmonary Rehabilitation
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
LWWCOPD for Pulmonary Rehabilitation
Other Intervention Name(s)
LWWCOPD
Intervention Description
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.
Primary Outcome Measure Information:
Title
Understanding your COPD questionaire
Description
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).
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
The Bristol COPD Knowledge Questionnaire (BCKQ)
Description
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).
Time Frame
6 weeks
Title
Global questions
Description
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.
Time Frame
6 weeks
Title
Qualitative data collection (patients' perspective)
Description
An evaluation questionnaire will be completed after each education session.
Time Frame
6 weeks
Title
Qualitative data collection (health professional's perspective)
Description
An evaluation questionnaire will be completed after each education session.
Time Frame
6 weeks

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brenda O'Neill, PhD
Organizational Affiliation
University of Ulster
Official's Role
Principal Investigator
Facility Information:
Facility Name
Belfast Health and Social Care Trust
City
Belfast
State/Province
Co ANtrim
Country
United Kingdom
Facility Name
Southern Eastern Health and Social Care Trust
City
Belfast
Country
United Kingdom
Facility Name
Western Health and Social Care Trust
City
Derry
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
18047889
Citation
Wilson JS, O'Neill B, Reilly J, MacMahon J, Bradley JM. Education in pulmonary rehabilitation: the patient's perspective. Arch Phys Med Rehabil. 2007 Dec;88(12):1704-9. doi: 10.1016/j.apmr.2007.07.040.
Results Reference
background
PubMed Identifier
23915179
Citation
Cosgrove D, Macmahon J, Bourbeau J, Bradley JM, O'Neill B. Facilitating education in pulmonary rehabilitation using the living well with COPD programme for pulmonary rehabilitation: a process evaluation. BMC Pulm Med. 2013 Aug 5;13:50. doi: 10.1186/1471-2466-13-50.
Results Reference
derived

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

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