CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 13 enrolled
Drug / intervention
Breathlessness Intervention Service (BIS) +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00711438
NCT00711438Phase 2Completed

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

Cambridge University Hospitals NHS Foundation Trust·interventional·Posted Jul 8, 2008·Updated Jul 8, 2008

In Brief

A Phase 2 clinical trial evaluating Breathlessness Intervention Service (BIS) and Best supportive care (Standard care) for Dyspnea. Completed, enrolled 13 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDyspnea
CountriesUnited Kingdom

Timeline

Phase 2CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 8, 2008
Enrollment StartApr 1, 2006
Primary CompletionApr 1, 2007
TodayJul 2, 2026
Enrollment to primary: 1 yearPosted 18.0 years ago

Interventions

Breathlessness Intervention Service (BIS)behavioral

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).

Best supportive care (Standard care)behavioral

Standard care: specialist outpatient appointments in secondary care (e.g. respiratory) which may include specialist nurse input, and primary care services.