Improving Patient Reported Outcome Measures in Catheter Ablation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorBarts & The London NHS Trust
About this trial
This study will assess whether more frequent measurement of patient reported outcome measures (PROMs) - specifically health related quality of life (HRQL) - can improve the evaluation of the clinical effectiveness and cost-effectiveness of catheter ablation of ventricular tachycardia (VT) in patients with an Implantable Cardioverter Defibrillator (ICD).
It is designed to have feasibility outcomes which contribute to answering the above.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
Validated quality of life questionnaire (EQ-5D & C-CAP)
Other interventionPatient quality of life to be assessed at baseline, 1, 2, 3, 4, 6, 9 and 12 months
Treatment groups
70 Participants
are divided into 2 treatment groupsGroup A: InterventionExperimental treatment 1 intervention
Group B: ComparatorActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Completion rate of HRQL forms for patients undergoing VT ablation and those starting or continuing AAD therapy
Time frame
1 year follow upSecondary outcomes
1
Recruitment rate of patients who fulfil study criteria
Time frame
1 year2
- Patient preferences for either paper or electronic HQRL (as a percentage of total recruitment)
Time frame
1 year3
Patient reported HRQL of VT ablation and AAD therapy on both EQ-5D and C-CAP
Time frame
18 months4
Impact on the cost-effectiveness calculation of VT ablation (using EQ-5D, and a number of different EQ-5D data points)
Using the Incremental Cost-effectiveness ratio
Time frame
18 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Barts & The London NHS Trust
Lead sponsor
University College, London
Collaborator
Source ClinicalTrials.gov