Patient Reported Outcome Measures for Ablation of Cardiac Arrhythmias
|ClinicalTrials.gov Identifier: NCT01672528|
Recruitment Status : Active, not recruiting
First Posted : August 27, 2012
Last Update Posted : July 19, 2017
|Condition or disease||Intervention/treatment|
|Cardiac Arrhythmia||Other: Interview Other: Questionnaires|
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.
|Study Type :||Observational|
|Estimated Enrollment :||630 participants|
|Official 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|
|Actual Study Start Date :||October 2012|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||December 2019|
Cardiac arrhythmia patients
Patients with cardiac arrhythmias consented to and awaiting a cardiac ablation procedure or post ablation.
Patient participates in a face-to-face interview to facilitate development of the new disease specific questionnaire
Patients will be sent questionnaires before their procedure, 8 - 12 after their procedure and at 1 and 5 years post procedure
- Is a newly developed disease specific tool able to accurately detect changes in health status following ablation for symptomatic cardiac arrhythmias? [ Time Frame: Up to 5 years post ablation ]This will be measured using responses to the new tool, EQ5D5L and clinical outcomes. Statistical evidence of the reliability and validity of the instruments will be illustrated via standard statistical methods.
- Do replies to the questionnaires show that the tool is responsive to change following ablation treatment? [ Time Frame: Average 10 weeks post ablation ]
- Do PROMs responses show concurrent, convergent and discriminant validity; corresponding with responses to EQ5D and clinical outcomes? [ Time Frame: Up to 5 years post-ablation. ]
- Is the tool sensitive to detecting whether patient expectations are met following ablation procedures for cardiac arrhythmias? [ Time Frame: Average 10 weeks post ablation ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01672528
|University Hospitals Birmingham Foundation Trust|
|Birmingham, United Kingdom, B15 2PR|
|Cardiff and Vale University Health Board|
|Cardiff, United Kingdom, CF14 7XB|
|Newcastle Upon Tyne Hospitals NHS Trusts|
|Newcastle, United Kingdom, NE7 7DN|
|Principal Investigator:||Grace Carolan-Rees, PhD||Cardiff and Vale University Health Board|