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Pilot Randomized Controlled Trial of a Breathlessness Intervention Service for Chronic Obstructive Pulmonary Disease (BIS-PhIInm)

This study has been completed.
King's College London
Information provided by:
Cambridge University Hospitals NHS Foundation Trust Identifier:
First received: July 3, 2008
Last updated: July 7, 2008
Last verified: October 2006
The aim of this study is to test the feasibility of conducting a pragmatic fast track Randomized Controlled Trial (RCT) of the Breathlessness Intervention Service (BIS) versus standard care for patients with COPD and their carers, and to begin testing the effectiveness of the intervention.

Condition Intervention Phase
Behavioral: Breathlessness Intervention Service (BIS)
Behavioral: Best supportive care (Standard care)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Supportive Care
Official Title: Phase II Pilot Pragmatic Single-Blinded Fast Track Randomised Controlled Trial of the Breathlessness Intervention Service Versus Standard Care for Patients With Chronic Obstructive Pulmonary Disease

Resource links provided by NLM:

Further study details as provided by Cambridge University Hospitals NHS Foundation Trust:

Primary Outcome Measures:
  • Visual Analogue Scale (VAS) - distress due to breathlessness [ Time Frame: End of intervention (8 weeks after baseline) ]

Secondary Outcome Measures:
  • Modified BORG [ Time Frame: As for primary outcome measure ]
  • VAS breathlessness at best /worst [ Time Frame: As for primary outcome measure ]
  • Mastery scale of CRQ [ Time Frame: As for primary outcome measure ]
  • SEIQoL-DW [ Time Frame: As for primary outcome measure ]
  • HADS [ Time Frame: As for primary outcome measure ]
  • social functioning [ Time Frame: As for primary outcome measure ]
  • WHO Performance scale [ Time Frame: As for primary outcome measure ]
  • experience of breathlessness & expectations / views of BIS [ Time Frame: As for primary outcome measure ]
  • Carer Burden Interview and Caregiver Appraisal Scale [ Time Frame: As for primary outcome measure ]

Enrollment: 13
Study Start Date: April 2006
Study Completion Date: April 2007
Primary Completion Date: April 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: FT
Breathlessness Intervention Service (BIS)
Behavioral: Breathlessness Intervention Service (BIS)
BIS consists of a clinical specialist physiotherapist & palliative care consultant. It aims to manage the symptom of breathlessness in patients with any disease using a rehabilitative approach. Interventions include: evidence-based non-pharmacological interventions (psychological, social & physical); palliative care input (e.g. end of life issues, psychosocial issues, family concerns); & pharmacological review. This BIS seeks to enhance self-management of breathlessness. Uniquely, care is located in clinic or in patients' own homes, as appropriate. Referrals come from medical specialists, GPs & allied health professionals (with medical consent).
Other Name: BIS
Active Comparator: WL
Best supportive care
Behavioral: Best supportive care (Standard care)
Standard care: specialist outpatient appointments in secondary care (e.g. respiratory) which may include specialist nurse input, and primary care services.
Other Name: Standard care

  Show Detailed Description


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:


  • Appropriate referral to the BIS
  • Diagnosis of COPD/COAD
  • Aged 18 years or over
  • Any patient who does not meet any of the exclusion criteria


  • The informal carers of patients specified above, who can be significant others, relatives, friends or neighbours
  • Aged 18 years or over
  • Any carer who does not meet the exclusion criteria

Exclusion Criteria:

  • Any patient/carer unable to give informed consent
  • Any patient living outside of Cambridgeshire PCT, West Essex PCT, East & North Hertfordshire PCT, or Suffolk PCT
  • Any patient who has previously had access to BIS
  • Any patient/carer who is demented or confused
  • Any patient/carer with learning difficulties
  • Any patient/carer from other vulnerable groups (e.g. head injury, severe trauma, and mental illness)
  • Any patient/carer who does not meet all of the inclusion criteria
  Contacts and Locations
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Please refer to this study by its identifier: NCT00711438

United Kingdom
Addenbrooke's Hospital
Cambridge, Cambridgeshire, United Kingdom, CB2 0QQ
Sponsors and Collaborators
Cambridge University Hospitals NHS Foundation Trust
King's College London
Principal Investigator: Sara Booth, FRCP Cambridge University Hopsitals NHS Foundation Trust
  More Information


Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Dr Sara Booth, Cambridge University Hospitals NHS Foundation Trust Identifier: NCT00711438     History of Changes
Other Study ID Numbers: BIS PhIInm v3 26/10/06
Study First Received: July 3, 2008
Last Updated: July 7, 2008

Keywords provided by Cambridge University Hospitals NHS Foundation Trust:
Palliative care
Randomised controlled trial
Chronic respiratory disease

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Respiration Disorders
Signs and Symptoms, Respiratory
Signs and Symptoms processed this record on April 24, 2017