Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0274135623
Study information
Scientific title
Acronym
Study hypothesis
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
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Not Specified
Patient information sheet
Condition
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
Phase
Not Specified
Drug names
Primary outcome measures
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 trial start date
01/04/2004
Overall trial end date
01/10/2006
Reason abandoned
Eligibility
Participant inclusion criteria
Patients with a confirmed diagnosis of Chronic Obstructive Pulmonary Disease whose therapy has been optimised and breathlessness remains a predominating symptom.
Participant type
Patient
Age group
Not Specified
Gender
Both
Target number of participants
Not provided at time of registration
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/04/2004
Recruitment end date
01/10/2006
Locations
Countries of recruitment
United Kingdom
Trial participating centre
West Suffolk Hospitals NHS Trust
Bury St Edmunds
IP33 2QZ
United Kingdom
Sponsor information
Organisation
Department of Health
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
West Suffolk Hospitals NHS Trust (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary