Patient Reported Outcome Measures for Ablation of Cardiac Arrhythmias

Completed

• Conditions: Cardiac Arrhythmia
• Interventions: Other: Interview; Other: Questionnaires

• Registration Number: NCT01672528
• Lead Sponsor: Cardiff and Vale University Health Board

Brief Summary

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

Detailed Description

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 Timeline

• Study First Submitted: 2012-08-16
• Study First Submitted QC: 2012-08-22
• Study First Posted: 2012-08-27
• Study Start: 2012-10
• Primary Completion: 2019-12-31
• Study Completion: 2019-12-31
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-17
• Last Update Posted: 2020-01-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 586

Inclusion Criteria

• Patients with symptomatic cardiac arrhythmias
• Consented to and awaiting a cardiac ablation procedure
• Able to read, write and understand English or Welsh
• Capable of giving informed written consent

Exclusion Criteria

• Not able to read, write and understand English or Welsh
• Not able to provide informed written consent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cardiac arrhythmia patients	Interview	Patients with cardiac arrhythmias consented to and awaiting a cardiac ablation procedure or post ablation.
Cardiac arrhythmia patients	Questionnaires	Patients with cardiac arrhythmias consented to and awaiting a cardiac ablation procedure or post ablation.

Primary Outcome Measures

Name	Time	Method
Is a newly developed disease specific tool able to accurately detect changes in health status following ablation for symptomatic cardiac arrhythmias?	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.

Secondary Outcome Measures

Name	Time	Method
Do replies to the questionnaires show that the tool is responsive to change following ablation treatment?	Average 10 weeks post ablation
Do PROMs responses show concurrent, convergent and discriminant validity; corresponding with responses to EQ5D and clinical outcomes?	Up to 5 years post-ablation.
Is the tool sensitive to detecting whether patient expectations are met following ablation procedures for cardiac arrhythmias?	Average 10 weeks post ablation

Trial Locations

Locations (3)

University Hospitals Birmingham Foundation Trust; 🇬🇧 Birmingham, United Kingdom

Cardiff and Vale University Health Board; 🇬🇧 Cardiff, United Kingdom

Newcastle Upon Tyne Hospitals NHS Trusts; 🇬🇧 Newcastle, United Kingdom