The PRINCE Trial: Pulmonary Rehabilitation In Nurse-led Community Environments
| ISRCTN | ISRCTN52403063 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN52403063 |
| Secondary identifying numbers | N/A |
- Submission date
- 24/09/2009
- Registration date
- 01/10/2009
- Last edited
- 06/01/2014
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Respiratory
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Kathy Murphy
Scientific
Scientific
School of Nursing and Midwifery
National University of Ireland
Áras Moyola
Galway
-
Ireland
| kathy.murphy@nuigalway.ie |
Study information
| Study design | Two armed single blind clustered randomised trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | GP practice |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a participant information sheet |
| 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 |
| Study acronym | PRINCE |
| Study objectives | 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(s) | 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 |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 01/01/2008 |
| Completion date | 31/12/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | 32 practices with 10 participants per practice are required |
| Key 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' |
| Key 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. |
| Date of first enrolment | 01/01/2008 |
| Date of final enrolment | 31/12/2012 |
Locations
Countries of recruitment
- Ireland
Study participating centre
School of Nursing and Midwifery
Galway
-
Ireland
-
Ireland
Sponsor information
Health Research Board (HRB) (Ireland)
Government
Government
73 Lower Baggot Street
Dublin
2
Ireland
| hrb@hrb.ie | |
| Website | http://www.hrb.ie |
"ROR" |
https://ror.org/003hb2249 |
Funders
Funder type
Government
Health Research Board (HRB) (Ireland)
Private sector organisation / Other non-profit organizations
Private sector organisation / Other non-profit organizations
- Alternative name(s)
- HRB
- Location
- Ireland
Pfizer (Ireland) - unconditional educational grant providing nursing, and support services and the temporary loan of two spirometers for the study
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 18/01/2011 | Yes | No | |
| Results article | results | 01/10/2013 | Yes | No | |
| Results article | results | 25/11/2013 | Yes | No |
