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.
BACKGROUND
A key strategy in improving care for people with chronic obstructive pulmonary disease (COPD) is the provision of pulmonary rehabilitation programmes. Pulmonary rehabilitation programmes have been successful in improving patients' sense of dyspnoea and Health Related Quality of Life. However, the effectiveness of structured education pulmonary rehabilitation programmes delivered at the level of the general practice on the health status of people with COPD remains uncertain and there is a need for a robust and fair assessment of this. The PRINCE study will evaluate the effectiveness of a Structured Education Pulmonary Rehabilitation Programme (SEPRP), delivered at the level of the general practice, on the health status of people with COPD.


METHODS
The PRINCE Trial is a two-armed, single blind cluster randomised trial conducted in the primary care setting in Ireland. Randomisation to control and intervention is at the level of the General Practice. Participants in the intervention arm will receive a SEPRP and those allocated to the control arm will receive usual care. Delivery of the SEPRP will be by a practice nurse and physiotherapist in the General Practice (GP) site. The primary outcome measure of the study will be health status as measured by the Chronic Respiratory Questionnaire (CRQ). Blinded outcome assessment will be undertaken at baseline and at twelve-fourteen weeks after completion of the programme. A comparison of outcomes between the intervention and control sites will be made to examine if differences exist and, if so, to what extent between control and experimental groups. Sample size calculations estimate that 32 practices with a minimum of 10 participants per practice are required, in total, to be randomised to control and intervention arms for power of at least 80% with alpha levels of 0.05, to determine a clinically significant change of 0.5 units in the CRQ. A cost effectiveness analysis will also be conducted.


CONCLUSIONS
The results of this trial are directly applicable to primary care settings in Ireland. Should a SEPRP delivered by practice nurses and physiotherapists in primary care be found to be effective in improving patients' sense of dyspnoea and HRQoL, then the findings would be applicable to many thousands of individuals in Ireland and beyond.
School of Nursing and Midwifery, National University of Ireland, Galway, Ireland. kathy.murphy@nuigalway.ie
Kathy
K
Murphy
Dympna
D
Casey
Declan
D
Devane
Adeline
A
Cooney
Bernard
B
McCarthy
Lorraine
L
Mee
Martina
M
Nichulain
Andrew W
AW
Murphy
John
J
Newell
Eamon
E
O' Shea
D002985:Clinical Protocols; D006304:Health Status; D006801:Humans; D007494:Ireland; D010353:Patient Education as Topic / Q000379:methods*; D011320:Primary Health Care; D029424:Pulmonary Disease, Chronic Obstructive / Q000534:rehabilitation*; D011788:Quality of Life; D012107:Research Design; D016037:Single-Blind Method; D011795:Surveys and Questionnaires
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