Chronic Obstructive Pulmonary DiseaseNCT01226836
Pulmonary Rehabilitation in Chronic Obstructive Pulmonary Disease (COPD): the Development and Feasibility of an Education Package
A study testing LWWCOPD for Pulmonary Rehabilitation in people with Chronic Obstructive Pulmonary Disease, run by University of Ulster at 3 sites in United Kingdom.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- LWWCOPD for Pulmonary Rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 3 sitesUnited Kingdom
- Study dates
- Jan 2010to Oct 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Participants
- Unable to safely partake in pulmonary rehabilitation (e.g. unstable angina, some musculoskeletal conditions).
- Unable to comprehend or follow instructions (e.g. dementia).
Trial locations and contacts
3 sites in 1 country.
United Kingdom3 sites
Belfast Health and Social Care Trust
Belfast, Co ANtrim
Southern Eastern Health and Social Care Trust
Belfast
Western Health and Social Care Trust
Londonderry
About this study
Official title: 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.
Read the 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.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- LWWCOPD for Pulmonary Rehabilitation
- Keywords
- Pulmonary Rehabilitation
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LWWCOPD for Pulmonary RehabilitationOther
Also called LWWCOPD
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.
| Study group | Role | What they receive |
|---|---|---|
| Living Well with COPD for Pulmonary Rehabilitation | Experimental | Not described Receives: Other: LWWCOPD for Pulmonary Rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 6 weeks
Secondary outcomes (4)
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).
Measured: 6 weeks
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.
Measured: 6 weeks
Qualitative data collection (patients' perspective)
An evaluation questionnaire will be completed after each education session.
Measured: 6 weeks
Qualitative data collection (health professional's perspective)
An evaluation questionnaire will be completed after each education session.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2010 (estimated)
- Study startJan 2010
- Primary completionOct 2010
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Ulster
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Principal investigator, Brenda O'Neill, University of Ulster
- Investigators
- Brenda O'Neill, PhD, Principal investigator, University of Ulster
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01226836
- Sponsor's protocol ID
- 09/0152
- Status last verified
- Oct 2018
- First submitted
- 21 Oct 2010
- Last updated
- 15 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 18047889Cosgrove 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.
PubMed 23915179
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pulmonary Rehabilitation in COPD: the Development and Feasibility of an Education Package
- ClinicalTrials.gov ID
- NCT01226836
- Acronym / sponsor ID
- 09/0152
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- Pulmonary Rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- University of UlsterUniversity, hospital or other
- 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
- Study start
- Jan 2010
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 22 Oct 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Living Well with COPD for Pulmonary Rehabilitation | Experimental | Other: LWWCOPD for Pulmonary Rehabilitation |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- Participants
- Unable to safely partake in pulmonary rehabilitation (e.g. unstable angina, some musculoskeletal conditions).
- Unable to comprehend or follow instructions (e.g. dementia).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LWWCOPD for Pulmonary RehabilitationAlso: LWWCOPDAs 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 | Living Well with COPD for Pulmonary Rehabilitation |
Primary outcome
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).
4 secondary outcomes
The Bristol COPD Knowledge Questionnaire (BCKQ)
Time frame: 6 weeks
Global questions
Time frame: 6 weeks
Qualitative data collection (patients' perspective)
Time frame: 6 weeks
Qualitative data collection (health professional's perspective)
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2018.
- Background: PubMed 18047889Wilson 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.
- Derived from this study: PubMed 23915179Cosgrove 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.
Related trials for Chronic Obstructive Pulmonary Disease
Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Not yet recruiting
The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
Not yet recruitingPhase 2
Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
RecruitingPhase 3
A Study to Investigate the Efficacy and Safety of Belumosudil Compared With Best Available Therapy in Participants Aged 12 Years or Older With Chronic Graft-versus-host Disease
Chronic Graft Versus Host Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brenda O'Neill, PhD principal investigator
University of Ulster
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LWWCOPD for Pulmonary Rehabilitation in people with Chronic Obstructive Pulmonary Disease, run by University of Ulster at 3 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Understanding your COPD questionaire (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01226836, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2018.