Patient Reported Outcome Measures for Ablation of Cardiac Arrhythmias

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
National Institute for Health and Clinical Excellence
University Hospital Birmingham NHS Foundation Trust
Newcastle-upon-Tyne Hospitals NHS Trust
University College, London
Information provided by (Responsible Party):
Dr Grace Carolan-Rees, Cardiff and Vale University Health Board
ClinicalTrials.gov Identifier:
NCT01672528
First received: August 16, 2012
Last updated: August 7, 2014
Last verified: August 2014
  Purpose

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


Condition Intervention
Cardiac Arrhythmia
Other: Interview
Other: Questionnaires

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by Cardiff and Vale University Health Board:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Do replies to the questionnaires show that the tool is responsive to change following ablation treatment? [ Time Frame: Average 10 weeks post ablation ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • Is the tool sensitive to detecting whether patient expectations are met following ablation procedures for cardiac arrhythmias? [ Time Frame: Average 10 weeks post ablation ] [ Designated as safety issue: No ]

Estimated Enrollment: 630
Study Start Date: September 2012
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Cardiac arrhythmia clinic

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01672528

Locations
United Kingdom
University Hospitals Birmingham Foundation Trust
Birmingham, United Kingdom, B15 2PR
Cardiff and Vale University Health Board
Cardiff, United Kingdom, CF14 7XB
Newcastle Upon Tyne Hospitals NHS Trusts
Newcastle, United Kingdom, NE7 7DN
Sponsors and Collaborators
Cardiff and Vale University Health Board
National Institute for Health and Clinical Excellence
University Hospital Birmingham NHS Foundation Trust
Newcastle-upon-Tyne Hospitals NHS Trust
University College, London
Investigators
Principal Investigator: Grace Carolan-Rees, PhD Cardiff and Vale University Health Board
  More Information

No publications provided

Responsible Party: Dr Grace Carolan-Rees, Director, Cardiff and Vale University Health Board
ClinicalTrials.gov Identifier: NCT01672528     History of Changes
Other Study ID Numbers: 12-CAD-5351, RRK 4429, 6125
Study First Received: August 16, 2012
Last Updated: August 7, 2014
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by Cardiff and Vale University Health Board:
Patient Reported Outcome Measures
PROMs
Cardiac arrhythmia
Cardiac ablation

Additional relevant MeSH terms:
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on August 26, 2014