Patient Reported Outcome Measures for Ablation of Cardiac Arrhythmias

Cardiff and Vale University Health Board

Status: Completed

Conditions: Cardiac Arrhythmia

Treatments: Other: Questionnaires; Other: Interview

Study type: Observational

Funder types: Other

Identifiers

NCT01672528

RRK 4429 (Other Identifier)

12-CAD-5351

6125 (Other Identifier)

Details and patient eligibility

About

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

Full 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.

Enrollment: 586 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

586 participants in 1 patient group

Cardiac arrhythmia patients

Description:

Patients with cardiac arrhythmias consented to and awaiting a cardiac ablation procedure or post ablation.

Treatment:

Other: Interview

Other: Questionnaires