Randomised controlled trial of nurse-led breathlessness intervention to improve the management of breathlessness for patients with Chronic Obstructive Pulmonary Disease (COPD)
| ISRCTN | ISRCTN53887688 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN53887688 |
| Secondary identifying numbers | N0274135623 |
- Submission date
- 30/09/2004
- Registration date
- 30/09/2004
- Last edited
- 08/04/2014
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Respiratory
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Mrs L Pearce
Scientific
Scientific
West Suffolk Hospitals NHS Trust
Hardwick Lane
Bury St Edmunds
IP33 2QZ
United Kingdom
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Not Specified |
| Scientific title | |
| Study objectives | To evaluate the effectiveness of a non-pharmacological nurse intervention through a breathlessness service to improve the management of breathlessness for patients with COPD |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Respiratory: Chronic obstructive pulmonary disease (COPD) |
| Intervention | Men and women with a confirmed diagnosis of COPD, who are physically able to access and attend the clinic on a regular basis will be randomised to attend either the nurse run breathlessness clinic or continue with routine care from a respiratory specialist nurse. The intervention will consist of goal setting, a range of strategies to manage breathing control, psychosocial support, and relaxation techniques. |
| Intervention type | Other |
| Primary outcome measure | 1. Dyspnoea and emotional function as measured by the results of self reported Chronic Respiratory Questionnaire (CRQ-SR). This measures dyspnoea, fatigue, emotional function and mastery. 2. Functional exercise capacity as measured by the six-minute shuttle walk. 3. Borg scores and Oxygen saturation will also be recorded. |
| Secondary outcome measures | Additional GP and hospital attendance and hospital admissions. |
| Overall study start date | 01/04/2004 |
| Completion date | 01/10/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Both |
| Target number of participants | Not provided at time of registration |
| Key inclusion criteria | Patients with a confirmed diagnosis of Chronic Obstructive Pulmonary Disease whose therapy has been optimised and breathlessness remains a predominating symptom. |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/04/2004 |
| Date of final enrolment | 01/10/2006 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
West Suffolk Hospitals NHS Trust
Bury St Edmunds
IP33 2QZ
United Kingdom
IP33 2QZ
United Kingdom
Sponsor information
Department of Health
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Website | http://www.dh.gov.uk/Home/fs/en |
|---|
Funders
Funder type
Government
West Suffolk Hospitals NHS Trust (UK)
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 |
