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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.
Sponsor:
Collaborator:
King's College London
Information provided by:
Cambridge University Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT00711438
First received: July 3, 2008
Last updated: July 7, 2008
Last verified: October 2006
History of Changes
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
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:

U.S. FDA Resources

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) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Modified BORG [ Time Frame: As for primary outcome measure ] [ Designated as safety issue: No ]
  • VAS breathlessness at best /worst [ Time Frame: As for primary outcome measure ] [ Designated as safety issue: No ]
  • Mastery scale of CRQ [ Time Frame: As for primary outcome measure ] [ Designated as safety issue: No ]
  • SEIQoL-DW [ Time Frame: As for primary outcome measure ] [ Designated as safety issue: No ]
  • HADS [ Time Frame: As for primary outcome measure ] [ Designated as safety issue: No ]
  • social functioning [ Time Frame: As for primary outcome measure ] [ Designated as safety issue: No ]
  • WHO Performance scale [ Time Frame: As for primary outcome measure ] [ Designated as safety issue: No ]
  • experience of breathlessness & expectations / views of BIS [ Time Frame: As for primary outcome measure ] [ Designated as safety issue: No ]
  • Carer Burden Interview and Caregiver Appraisal Scale [ Time Frame: As for primary outcome measure ] [ Designated as safety issue: No ]

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Patients:

  • 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

Carers:

  • 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00711438

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

Publications:

Responsible Party: Dr Sara Booth, Cambridge University Hospitals NHS Foundation Trust
ClinicalTrials.gov 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
Health Authority: United Kingdom: Research Ethics Committee
United Kingdom: National Health Service
United Kingdom: Department of Health

Keywords provided by Cambridge University Hospitals NHS Foundation Trust:
Breathlessness
Dyspnoea
Dyspnea
Palliative care
 RCT
Randomised controlled trial
COPD
Chronic respiratory disease

Additional relevant MeSH terms:
Dyspnea
Lung Diseases
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
 Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms

ClinicalTrials.gov processed this record on June 18, 2013