Patient Reported Outcome Measures for Ablation of Cardiac Arrhythmias

NCT01672528 | Completed

• 3 other identifiers: 12-CAD-5351RRK 44296125
• Study Type: observational
• Target: 586
• Locations: 1 country
• Sites: 3

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

Conditions

Cardiac Arrhythmia

Keywords

Patient Reported Outcome Measures; PROMs; Cardiac arrhythmia; Cardiac ablation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

Study Arms (1)

Cardiac arrhythmia patients

Patients with cardiac arrhythmias consented to and awaiting a cardiac ablation procedure or post ablation.

Other: Interview; Other: Questionnaires

Interventions

Interview OTHER

Patient participates in a face-to-face interview to facilitate development of the new disease specific questionnaire

Also known as: Disease specific questionnaire, EQ5D5L

Cardiac arrhythmia patients

Questionnaires OTHER

Patients will be sent questionnaires before their procedure, 8 - 12 after their procedure and at 1 and 5 years post procedure

Also known as: Disease specific questionnaire, EQ5D

Cardiac arrhythmia patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Cardiac arrhythmia clinic

You may qualify if:

• 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

You may not qualify if:

• Not able to read, write and understand English or Welsh
• Not able to provide informed written consent

Sponsors & Collaborators

• Cardiff and Vale University Health Board: lead
• National Institute for Health and Clinical Excellence: collaborator
• University Hospital Birmingham NHS Foundation Trust: collaborator
• Newcastle-upon-Tyne Hospitals NHS Trust: collaborator
• University College, London: collaborator

Study Sites (3)

University Hospitals Birmingham Foundation Trust

Birmingham, B15 2PR, United Kingdom

Location

Cardiff and Vale University Health Board

Cardiff, CF14 7XB, United Kingdom

Location

Newcastle Upon Tyne Hospitals NHS Trusts

Newcastle, NE7 7DN, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 26104746 DERIVED

MeSH Terms

Conditions

Arrhythmias, Cardiac

Interventions

Interviews as Topic; Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Grace Carolan-Rees, PhD

  Cardiff and Vale University Health Board

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: August 16, 2012
• First Posted: August 27, 2012
• Study Start: October 1, 2012
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: January 21, 2020

Record last verified: 2020-01

Locations

GB (3)