Clinical trial NCT01672528: Patient Reported Outcome Measures for Ablation of Cardiac Arrhythmias
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiac Arrhythmia
Keywords: Patient Reported Outcome Measures
PROMs
Cardiac arrhythmia
Cardiac ablation
Lead sponsor: Cardiff and Vale University Health Board
Sponsor class: OTHER_GOV
Collaborators: name: National Institute for Health and Clinical Excellence
name: University Hospital Birmingham NHS Foundation Trust
name: Newcastle-upon-Tyne Hospitals NHS Trust
name: University College, London
First posted: 2012-08-27
Enrollment: 586
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cardiac arrhythmia clinic

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Is a newly developed disease specific tool able to accurately detect changes in health status following ablation for symptomatic cardiac arrhythmias?
timeFrame: 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?
timeFrame: Average 10 weeks post ablation
measure: Do PROMs responses show concurrent, convergent and discriminant validity; corresponding with responses to EQ5D and clinical outcomes?
timeFrame: Up to 5 years post-ablation.
measure: Is the tool sensitive to detecting whether patient expectations are met following ablation procedures for cardiac arrhythmias?
timeFrame: Average 10 weeks post ablation
Other outcomes:
Locations:
city: Birmingham
country: United Kingdom
facility: University Hospitals Birmingham Foundation Trust
city: Cardiff
country: United Kingdom
facility: Cardiff and Vale University Health Board
city: Newcastle
country: United Kingdom
facility: Newcastle Upon Tyne Hospitals NHS Trusts
Study officials:
affiliation: Cardiff and Vale University Health Board
name: Grace Carolan-Rees, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.