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

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

Study Overview

• Status: Completed
• Conditions: Cardiac Arrhythmia
• Intervention / Treatment: Other: Interview; Other: Questionnaires

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 Type: Observational
• Enrollment (Actual): 586

Contacts and Locations

Study Locations

• United Kingdom
  • Birmingham, United Kingdom, B15 2PR
    • University Hospitals Birmingham Foundation Trust
  • Cardiff, United Kingdom, CF14 7XB
    • Cardiff and Vale University Health Board
  • Newcastle, United Kingdom, NE7 7DN
    • Newcastle Upon Tyne Hospitals NHS Trusts

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Cardiac arrhythmia clinic

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cardiac arrhythmia patients; Patients with cardiac arrhythmias consented to and awaiting a cardiac ablation procedure or post ablation.	Other: Interview; Patient participates in a face-to-face interview to facilitate development of the new disease specific questionnaire; Other Names: Disease specific questionnaire; EQ5D5L; Other: Questionnaires; Patients will be sent questionnaires before their procedure, 8 - 12 after their procedure and at 1 and 5 years post procedure; Other Names: Disease specific questionnaire; EQ5D

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Cardiff and Vale University Health Board
• Collaborators: University College, London; University Hospital Birmingham NHS Foundation Trust; Newcastle-upon-Tyne Hospitals NHS Trust; National Institute for Health and Clinical Excellence
• Investigators: Principal Investigator: Grace Carolan-Rees, PhD, Cardiff and Vale University Health Board

Publications and helpful links

General Publications

• Withers KL, Wood KA, Carolan-Rees G, Patrick H, Lencioni M, Griffith M. Living on a knife edge-the daily struggle of coping with symptomatic cardiac arrhythmias. Health Qual Life Outcomes. 2015 Jun 24;13:86. doi: 10.1186/s12955-015-0282-9.

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 1, 2012
• Primary Completion (ACTUAL): December 31, 2019
• Study Completion (ACTUAL): December 31, 2019

Study Registration Dates

• First Submitted: August 16, 2012
• First Submitted That Met QC Criteria: August 22, 2012
• First Posted (ESTIMATE): August 27, 2012

Study Record Updates

• Last Update Posted (ACTUAL): January 21, 2020
• Last Update Submitted That Met QC Criteria: January 17, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: Cardiac ablation; Patient Reported Outcome Measures; Cardiac arrhythmia; PROMs
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac
• Other Study ID Numbers: 12-CAD-5351; 6125 (Other Identifier: Stanford IRB); RRK 4429 (OTHER: Birmingham R&D)