Patient Reported Outcome Measures for Ablation of Cardiac Arrhythmias

NCT ID: NCT01672528


Title
A Multicentre, Prospective Observational Study to Develop, Evaluate and Validate Patient Reported Outcome Measures (PROMs) for Patients Treated With Cardiac Ablation for Symptomatic Cardiac Arrhythmias
Purpose
A multicentre, prospective observational study to develop, evaluate and validate Patient Reported Outcome Measures (PROMs) for patients treated with cardiac ablation for symptomatic cardiac arrhythmias
Details
This study aims to develop, evaluate and validate disease specific PROMs for patients in the UK treated with cardiac ablation for cardiac arrhythmias. The potential benefits include support for clinicians to improve their performance, assisting patients in making informed choices and strengthening audit and research. Phase 1 of the study will involve patient interviews with approximately 30 patients from 2 sites. These, together with input from a multidisciplinary team, will aim to improve drafts of disease specific questionnaires. This will be followed by Phase 2 which will trial the questionnaires in a group of approximately 600 patients from three sites. In Phase 2 patients will be asked to complete a pre-procedure questionnaire relating to their symptoms, quality of life and procedure expectations. They will also be sent post-procedure questionnaires relating to procedural outcomes, symptoms and quality of life at 8-16 weeks post procedure and at 1 and 5 years post-procedure. The responses obtained from these PROMs will be used to undertake recommended statistical tests of reliability and validity.
Conditions
Cardiac Arrhythmia
Keywords
Patient Reported Outcome Measures, PROMs, Cardiac arrhythmia, Cardiac ablation
Source
Cardiff and Vale University Health Board
Sponsors
Cardiff and Vale University Health Board, National Institute for Health and Clinical Excellence, University Hospital Birmingham NHS Foundation Trust, Newcastle-upon-Tyne Hospitals NHS Trust, University College, London
Status
Active, not recruiting
Acronym
Last Updated
31 Jan 2016
URL
Official Link
Locations
United Kingdom