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

Completed

• Conditions: Chronic obstructive pulmonary disease (COPD); Respiratory; Other chronic obstructive pulmonary disease

• Registration Number: ISRCTN52403063
• Lead Sponsor: Health Research Board (HRB) (Ireland)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-10-01
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 320

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Health status as measured by the Chronic Respiratory Questionnaire (CRQ)

Secondary Outcome Measures

Name	Time	Method
1. Incremental Shuttle Walking Test<br>2. Self-Efficacy for Managing Chronic Disease 6-Item Scale<br>3. Economic analysis specific:<br>3.1. EuroQol EQ-5D<br>3.2. Utilisation of health care service:<br>3.2.1. Hospital admissions/length of stay<br>3.2.2. Attendance at the emergency department<br>3.2.3. Attendance at/by GP<br>3.2.4. Attendance at/by Practice Nurse<br>3.2.5. Attendance at/by Public Health Nurse<br>3.2.6. Attendance at/by Physiotherapy<br>3.2.7. Attendance at/by Social Worker<br>3.2.8. Attendance at/by Dietician<br>3.2.9. Outpatient attendances<br>3.2.10. Attendance at/by consultant<br>3.2.11. Utilisation of home help