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
Protocol serial number	N0274135623
Sponsor	Department of Health
Funder	West Suffolk Hospitals NHS Trust (UK)

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

Mrs L Pearce
Scientific

West Suffolk Hospitals NHS Trust
Hardwick Lane
Bury St Edmunds
IP33 2QZ
United Kingdom

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
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(s)	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.
Key secondary outcome measure(s)	Additional GP and hospital attendance and hospital admissions.
Completion date	01/10/2006

Participant type(s)	Patient
Age group	Not Specified
Sex	All
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

West Suffolk Hospitals NHS Trust

Bury St Edmunds
IP33 2QZ
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan