Contact information
Type
Scientific
Primary contact
Prof Kathy Murphy
ORCID ID
Contact details
School of Nursing and Midwifery
National University of Ireland
Áras Moyola
Galway
-
Ireland
kathy.murphy@nuigalway.ie
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
A cluster randomised controlled trial evaluating the effectiveness of a structured pulmonary rehabilitation programme (SPRP) for improving the health status of people with chronic obstructive pulmonary disease (COPD) delivered at the level of general practice compared with usual care
Acronym
PRINCE
Study hypothesis
The aim of this study is to evaluate the effectiveness of a structured pulmonary rehabilitation programme on the health status of people with chronic obstructive pulmonary disease (COPD) delivered at the level of the general practice compared with usual care.
Ethics approval
1. Irish College of General Practitioners (ICGP), National University of Ireland, Galway Research Ethics Committee, approved on the 30th September 2008
2. Health Research Board (HRB) approved initially on the 6th March 2008 and gave secondary approval post-submitted amendments on the 26th September 2008
Study design
Two armed single blind clustered randomised trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
GP practices
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a participant information sheet
Condition
Chronic obstructive pulmonary disease (COPD)
Intervention
Randomisation to control and intervention is at the level of the General Practice.
The experimental group will receive a structured pulmonary rehabilitation programme (SPRP), which consists of an eight week programme with one 2-hour session each week (16 hours total duration). The SRPR will be facilitated by Practice Nurses and Physiotherapists who have received a Practice Nurse preparation programme (PNPP) (a three day programme focused on preparing practice nurses to deliver the structured education programme) or a Physiotherapist preparation programme (PNPP) (a one day programme focused on preparing physiotherapists to deliver the structured education programme). Practice Nurses and Physiotherapists will be supported in the delivery of the programme by having recourse to members of the research team for purposes of clarification on training materials, identification of sources of information in response to specific patient queries.
A standardised curriculum and programme materials will be developed by the research team for use in the intervention. The SPRP curriculum will be developed in accordance with the key criteria for structured education programmes and will include the development of a course philosophy, a detailed curriculum, development of common course materials and training for all educators.
Secondary sponsor details:
Mr David Gallagher MD
Pfizer Health Care Ireland
9 River Walk
National Digital Park
Citywest Business Campus
Dublin 24
Ireland
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
Health status as measured by the Chronic Respiratory Questionnaire (CRQ)
Secondary outcome measures
1. Incremental Shuttle Walking Test
2. Self-Efficacy for Managing Chronic Disease 6-Item Scale
3. Economic analysis specific:
3.1. EuroQol EQ-5D
3.2. Utilisation of health care service:
3.2.1. Hospital admissions/length of stay
3.2.2. Attendance at the emergency department
3.2.3. Attendance at/by GP
3.2.4. Attendance at/by Practice Nurse
3.2.5. Attendance at/by Public Health Nurse
3.2.6. Attendance at/by Physiotherapy
3.2.7. Attendance at/by Social Worker
3.2.8. Attendance at/by Dietician
3.2.9. Outpatient attendances
3.2.10. Attendance at/by consultant
3.2.11. Utilisation of home help
Overall trial start date
01/01/2008
Overall trial end date
31/12/2012
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Practice eligibility criteria:
1. Supported by a practice nurse
2. Practice supported by a computerised patient (medication recording) system
3. Commitment on the part of the practice team to participate in the proposed work
4. Have a client population with greater than 2500 clients
5. Participation by a minimum of 10 consenting patients meeting eligibility criteria
Participant eligibility criteria:
1. Patient with an existing diagnosis or suspected of having COPD. Patient eligibility algorithm provided to each practice to support identification of participants.
2. COPD confirmed at baseline assessment by spirometer results of:
2.1. Post-bronchial dilator forced expiratory volume in one second (FEV1)/forced vital capacity (FVC) ratio of less than 70%* unless body mass index (BMI) greater than 30 in which case FEV1/FVC ratio greater than 70% are acceptable provided other criteria fully met
2.2. Post-bronchial dilator predicted value of FEV1 greater than or equal to 30% and less than or equal to 80%**
3. Must be able to converse in and read English as initial delivery of programme will be only available in English
4. Ability to understand the study and a willingness to give informed consent
*This value is reported in the spirometry result under the column heading 'Base'
**This value is reported in the spirometry result under the column heading '%Pr'
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
32 practices with 10 participants per practice are required
Participant exclusion criteria
Any significant underlying co-morbidities or mental health problems (based on the recorded judgement of practice staff) which are likely to impair their capacity to successful participate in or assimilate new information as part of the rehabilitation programme or which may pose a risk to their health.
Recruitment start date
01/01/2008
Recruitment end date
31/12/2012
Locations
Countries of recruitment
Ireland
Trial participating centre
School of Nursing and Midwifery
Galway
-
Ireland
Sponsor information
Organisation
Health Research Board (HRB) (Ireland)
Sponsor details
73 Lower Baggot Street
Dublin
2
Ireland
hrb@hrb.ie
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Health Research Board (HRB) (Ireland)
Alternative name(s)
HRB
Funding Body Type
private sector organisation
Funding Body Subtype
other non-profit
Location
Ireland
Funder name
Pfizer (Ireland) - unconditional educational grant providing nursing, and support services and the temporary loan of two spirometers for the study
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
1. 2011 results in: http://www.ncbi.nlm.nih.gov/pubmed/21244668
2. 2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/24282243
3. 2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/23736156
Publication citations
-
Results
Murphy K, Casey D, Devane D, Cooney A, McCarthy B, Mee L, Nichulain M, Murphy AW, Newell J, O' Shea E, A cluster randomised controlled trial evaluating the effectiveness of a structured pulmonary rehabilitation education programme for improving the health status of people with chronic obstructive pulmonary disease (COPD): The PRINCE Study protocol., BMC Pulm Med, 2011, 11, 4, doi: 10.1186/1471-2466-11-4.
-
Results
Gillespie P, O'Shea E, Casey D, Murphy K, Devane D, Cooney A, Mee L, Kirwan C, McCarthy B, Newell J, , The cost-effectiveness of a structured education pulmonary rehabilitation programme for chronic obstructive pulmonary disease in primary care: the PRINCE cluster randomised trial., BMJ Open, 2013, 3, 11, e003479, doi: 10.1136/bmjopen-2013-003479.
-
Results
Casey D, Murphy K, Devane D, Cooney A, McCarthy B, Mee L, Newell J, O'Shea E, Scarrott C, Gillespie P, Kirwan C, Murphy AW, The effectiveness of a structured education pulmonary rehabilitation programme for improving the health status of people with moderate and severe chronic obstructive pulmonary disease in primary care: the PRINCE cluster randomised trial., Thorax, 2013, 68, 10, 922-928, doi: 10.1136/thoraxjnl-2012-203103.