NCT01672528

Patient Reported Outcome Measures for Ablation of Cardiac Arrhythmias

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 586 (actual)
• Sponsor: Cardiff and Vale University Health Board · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cardiac Arrhythmia

Interventions

Type	Name	Description
OTHER	Interview	Patient participates in a face-to-face interview to facilitate development of the new disease specific questionnaire
OTHER	Questionnaires	Patients will be sent questionnaires before their procedure, 8 - 12 after their procedure and at 1 and 5 years post procedure

Timeline

• Start date: 2012-10-01
• Primary completion: 2019-12-31
• Completion: 2019-12-31
• First posted: 2012-08-27
• Last updated: 2020-01-21

Locations

3 sites across 1 country: United Kingdom