- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01226836
Pulmonary Rehabilitation in Chronic Obstructive Pulmonary Disease (COPD): the Development and Feasibility of an Education Package
Pulmonary Rehabilitation in COPD: the Development and Feasibility of an Education Package
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
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
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
Genders Eligible for Study
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
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:
|
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
Publications and helpful links
General 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 09/0152
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.
Clinical Trials on Chronic Obstructive Pulmonary Disease
-
Spire, Inc.ResMedCompletedSevere Chronic Obstructive Pulmonary Disease | Moderate Chronic Obstructive Pulmonary DiseaseUnited States
-
Karaganda Medical UniversityCompletedChronic Obstructive Pulmonary Disease | Chronic Obstructive Pulmonary Disease Moderate | Chronic Obstructive Pulmonary Disease SevereKazakhstan
-
Randall DebattistaUniversity of Malta, Faculty of Health SciencesNot yet recruitingChronic Obstructive Pulmonary Disease Moderate | Acute Exacerbation of COPD | Chronic Obstructive Pulmonary Disease Severe
-
Cukurova UniversityCompletedAnesthesia | Chronic Obstructive Pulmonary Disease Moderate | Lungcancer | Chronic Obstructive Pulmonary Disease Severe | Chronic Obstructive Pulmonary Disease MildTurkey
-
National Taipei University of Nursing and Health...TerminatedChronic Pulmonary Disease | Chronic Obstructive Pulmonary Disease Exacerbation | Chronic Obstructive Pulmonary Disease With ExacerbationTaiwan
-
Taipei Medical UniversityUnknownChronic Obstructive Pulmonary Disease Severe | Chronic Obstructive Pulmonary Disease End StageTaiwan
-
Kırıkkale UniversityRecruitingCOPD (Chronic Obstructive Pulmonary Disease)Turkey
-
Hopital FochAir Liquide SARecruitingChronic Obstructive Pulmonary Disease SevereFrance
-
Fundación para la Investigación del Hospital Clínico...Not yet recruitingCOPD, Chronic Obstructive Pulmonary DiseaseSpain
-
Canandaigua VA Medical CenterRecruitingChronic Obstructive Pulmonary Disease ModerateUnited States
Clinical Trials on LWWCOPD for Pulmonary Rehabilitation
-
University of Santa Cruz do SulUnknownChronic Obstructive Pulmonary DiseaseBrazil
-
Faculty of Medicine, SousseCompletedChronic Obstructive Pulmonary DiseaseTunisia
-
Universidade Federal de Santa MariaCompletedChronic Obstructive Pulmonary DiseaseBrazil
-
Istanbul Medipol University HospitalRecruitingLung Diseases | Bronchiectasis | Lung Diseases, Interstitial | Pulmonary RehabilitationTurkey
-
La Trobe UniversityMonash University; The Alfred; Austin HealthCompletedChronic Obstructive Pulmonary DiseaseAustralia
-
Aveiro UniversityCentro Hospitalar do Baixo VougaRecruitingChronic Obstructive Pulmonary Disease | Interstitial Lung DiseasePortugal
-
National Cheng-Kung University HospitalCompletedTelerehabilitation | Pulmonary Rehabilitation | Compliance, Patient | COPD | Cardiopulmonary Exercise TestTaiwan
-
Istanbul Medipol University HospitalCompletedEmphysema | Bronchoscopic Lung Volume Reduction | Hospital-based Pulmonary Rehabilitation | Home-based Pulmonary RehabilitationTurkey
-
Hospital Clinic of BarcelonaSociedad Española de Neumología y Cirugía TorácicaUnknownNon-cystic Fibrosis Bronchiectasis