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The PRINCE Trial: Pulmonary Rehabilitation In Nurse-led Community Environments

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN52403063
Enrollment
320
Registered
2009-10-01
Start date
2008-01-01
Completion date
Unknown
Last updated
2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic obstructive pulmonary disease (COPD) Respiratory Other chronic obstructive pulmonary disease

Interventions

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 ei

Sponsors

Health Research Board (HRB) (Ireland)
Lead Sponsor

Eligibility

Inclusion criteria

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'

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
Health status as measured by the Chronic Respiratory Questionnaire (CRQ)

Secondary

MeasureTime frame
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

Countries

Ireland

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 10, 2026