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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01226836
Other study ID # 09/0152
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 2010
Est. completion date October 2010

Study information

Verified date October 2018
Source University of Ulster
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 53
Est. completion date October 2010
Est. primary completion date October 2010
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
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

Sponsors (5)

Lead Sponsor Collaborator
University of Ulster Belfast Health and Social Care Trust, McGill University Health Center, South Eastern Health and Social Care Trust, Western Health and Social Care Trust

Country where clinical trial is conducted

United Kingdom, 

References & Publications (1)

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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). 6 weeks
Secondary 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). 6 weeks
Secondary 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. 6 weeks
Secondary Qualitative data collection (patients' perspective) An evaluation questionnaire will be completed after each education session. 6 weeks
Secondary Qualitative data collection (health professional's perspective) An evaluation questionnaire will be completed after each education session. 6 weeks
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