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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00711438
Recruitment Status : Completed
First Posted : July 8, 2008
Last Update Posted : July 8, 2008
King's College London
Information provided by:
Cambridge University Hospitals NHS Foundation Trust

Brief Summary:
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 or disease Intervention/treatment Phase
Dyspnea Behavioral: Breathlessness Intervention Service (BIS) Behavioral: Best supportive care (Standard care) Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (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
Study Start Date : April 2006
Actual Primary Completion Date : April 2007
Actual Study Completion Date : April 2007

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00711438

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


Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Dr Sara Booth, Cambridge University Hospitals NHS Foundation Trust Identifier: NCT00711438    
Other Study ID Numbers: BIS PhIInm v3 26/10/06
First Posted: July 8, 2008    Key Record Dates
Last Update Posted: July 8, 2008
Last Verified: October 2006
Keywords provided by Cambridge University Hospitals NHS Foundation Trust:
Palliative care
Randomised controlled trial
Chronic respiratory disease
Additional relevant MeSH terms:
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Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Signs and Symptoms, Respiratory
Signs and Symptoms