Condition category
Respiratory
Date applied
30/09/2004
Date assigned
30/09/2004
Last edited
08/04/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mrs L Pearce

ORCID ID

Contact details

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

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

http://www.dh.gov.uk/Home/fs/en

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

Publication citations

Additional files

Editorial Notes