Patient Reported Outcome Measures for Ablation of Cardiac Arrhythmias

Cardiac Arrhythmia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01672528
• Other study ID #: 12-CAD-5351
• Secondary ID: RRK 44296125
• Status: Completed
• Start date: October 2012
• Est. completion date: December 31, 2019

Study information

• Verified date: January 2020
• Source: Cardiff and Vale University Health Board
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 586
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arrhythmias, Cardiac
• Cardiac Arrhythmia

Intervention

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

Locations

Country	Name	City	State
United Kingdom	University Hospitals Birmingham Foundation Trust	Birmingham
United Kingdom	Cardiff and Vale University Health Board	Cardiff
United Kingdom	Newcastle Upon Tyne Hospitals NHS Trusts	Newcastle

Sponsors (5)

Lead Sponsor	Collaborator
Cardiff and Vale University Health Board	National Institute for Health and Clinical Excellence, Newcastle-upon-Tyne Hospitals NHS Trust, University College, London, University Hospital Birmingham NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

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