Patient Reported Outcome Measures for Ablation of Cardiac Arrhythmias

Cardiff and Vale University Health Board586 enrolled

Overview

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

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

Enrollment

586

Conditions

Cardiac Arrhythmia

Interventions

InterviewOTHER

Patient participates in a face-to-face interview to facilitate development of the new disease specific questionnaire

QuestionnairesOTHER

Patients will be sent questionnaires before their procedure, 8 - 12 after their procedure and at 1 and 5 years post procedure

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

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

Outcomes

Primary Outcomes

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

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.

Time frame: Up to 5 years post ablation

Secondary Outcomes

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

Data from ClinicalTrials.gov

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