Overview

This trial is active, not recruiting.

Condition cardiac arrhythmia
Treatments interview, questionnaires
Sponsor Cardiff and Vale University Health Board
Collaborator National Institute for Health and Clinical Excellence
Start date September 2012
End date December 2018
Trial size 630 participants
Trial identifier NCT01672528, 12-CAD-5351, 6125, RRK 4429

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
Patients with cardiac arrhythmias consented to and awaiting a cardiac ablation procedure or post ablation.
interview Disease specific questionnaire
Patient participates in a face-to-face interview to facilitate development of the new disease specific questionnaire
questionnaires Disease specific questionnaire
Patients will be sent questionnaires before their procedure, 8 - 12 after their procedure and at 1 and 5 years post procedure

Primary Outcomes

Measure
Is a newly developed disease specific tool able to accurately detect changes in health status following ablation for symptomatic cardiac arrhythmias?
time frame: Up to 5 years post ablation

Secondary Outcomes

Measure
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

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

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
Principal investigator Grace Carolan-Rees, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by Cardiff and Vale University Health Board.