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Zio Real-World Evaluation

  • Research type

    Research Study

  • Full title

    A multi-centre cohort study comparing health outcome data from Holter monitoring to 14 day Zio monitoring in people where ambulatory ECG monitoring is required

  • IRAS ID

    305550

  • Contact name

    Anna Barnes

  • Contact email

    anna.barnes@kcl.ac.uk

  • Sponsor organisation

    King's College London

  • Clinicaltrials.gov Identifier

    N/A, N/A

  • Duration of Study in the UK

    0 years, 8 months, 31 days

  • Research summary

    This research is a multi-centre cohort study comparing 6-month pre-COVID data for standard of care ambulatory ECG monitoring (Holter) with 6-month post-COVID data for Zio XT Service by iRhythm technologies in NHS stroke/TIA and cardiology clinics.

    Zio is standard of care at the NHS sites participating in this study, but it is not standard of care across the NHS. The standard of care received by patients involved in this study will not be affected by their participation in the study. However, should Zio be adopted more widely by the NHS, a change in pathway will be required. The Zio device is CE marked as a Class IIa and will be used within its intended purpose in this study.

    The aim of the research is to asses the impact of introducing Zio XT Service on clinical workflow and patient outcomes to help inform decisions related to future adoption by the NHS.

    The research includes a qualitative component related to a sub-set of patients with regards to their experience. For this component, an additional cohort of patients using the Zio patch from both the cariology and stroke/TIA population will be included for the patient experience aspect of the study. This will be done through a patient questionnaire.

    The patient questionnaire will be self-administered. The primary outcome of this is to investigate overall patient preference for Zio monitor or Holter monitor.

    The qualitative component will also investigate healthcare professionals' (HCP) experience of the Zio monitor. This will be done through a self-administered HCP questionnaire.

    The study will be conducted in England in three NHS trusts: Liverpool Heart & Chest Hospital, North Bristol NHS Trust and Gloucestershire NHS Foundation Trust. The data collection is expected to take no longer than six months, followed by four to five months for data analysis and reporting of results.

  • REC name

    Yorkshire & The Humber - South Yorkshire Research Ethics Committee

  • REC reference

    22/YH/0206

  • Date of REC Opinion

    11 Aug 2022

  • REC opinion

    Favourable Opinion

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