Condition category
Respiratory
Date applied
24/09/2009
Date assigned
01/10/2009
Last edited
06/01/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http:\\princestudy.com

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 measures

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

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

http://www.hrb.ie

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

Results - basic reporting

Publication summary

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

  1. 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.

  2. 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.

  3. 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.

Additional files

Editorial Notes