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11 February 2012 
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Randomised controlled trial of nurse-led breathlessness intervention to improve the management of breathlessness for patients with Chronic Obstructive Pulmonary Disease (COPD)
ISRCTN ISRCTN53887688
ClinicalTrials.gov identifier
Public title Randomised controlled trial of nurse-led breathlessness intervention to improve the management of breathlessness for patients with Chronic Obstructive Pulmonary Disease (COPD)
Scientific title
Acronym N/A
Serial number at source N0274135623
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
Lay summary
Ethics approval Not provided at time of registration
Study design Randomised controlled trial
Countries of recruitment United Kingdom
Disease/condition/study domain Respiratory: Chronic obstructive pulmonary disease (COPD)
Participants - inclusion criteria Patients with a confirmed diagnosis of Chronic Obstructive Pulmonary Disease whose therapy has been optimised and breathlessness remains a predominating symptom.
Participants - exclusion criteria Not provided at time of registration
Anticipated start date 01/04/2004
Anticipated end date 01/10/2006
Status of trial Completed
Patient information material
Target number of participants Not provided at time of registration
Interventions 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.
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.
Secondary outcome measure(s) Additional GP and hospital attendance and hospital admissions.
Sources of funding West Suffolk Hospitals NHS Trust (UK)
Trial website
Publications
Contact name Mrs  L  Pearce
  Address West Suffolk Hospitals NHS Trust
Hardwick Lane
  City/town Bury St Edmunds
  Zip/Postcode IP33 2QZ
  Country United Kingdom
Sponsor Record Provided by the NHSTCT Register - 2004 Update - Department of Health (UK)
  Address The Department of Health,
Richmond House,
79 Whitehall
  City/town London
  Zip/Postcode SW1A 2NL
  Country United Kingdom
  Tel +44 (0)20 7307 2622
  Email dhmail@doh.gsi.org.uk
  Sponsor website: http://www.dh.gov.uk/Home/fs/en
Date applied 30/09/2004
Last edited 13/04/2011
Date ISRCTN assigned 30/09/2004
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