Zio Real-World Evaluation

NCT05560828 | Unknown

• 1 other identifier: KCLAI001
• Study Type: observational
• Target: 1,440
• Locations: 0 countries
• Sites: N/A

Brief Summary

In 2020 an independent evaluation of the Zio service as part of the Digital Health Technologies programme at NICE was conducted. From the available clinical and economic evidence, the evaluation concluded that further evidence is needed to estimate the resource use associated with Zio compared with standard care, particularly the number of outpatient visits and repeat testing needed. Additionally it recommended further evidence is needed for the longer-term clinical consequences such as anticoagulant uptake and other changes to treatment related to the results from monitoring. (MTG52) Therefore, this study aims to address these uncertainties and identify whether the Zio service could be used in the health and social care system in England. This will be assessed using a multicentre, cohort study design consisting of two cohorts. The data for the existing standard of care cohort using Holter monitor (cohort 1) will be collected from 6-month retrospective pre-covid data, and, for the Zio service cohort (cohort 2), data will be collected retrospectively over a 6-month period. Each cohort will include two separate populations recruited from cardiology clinics and stroke/TIA clinics. The main objective of this study is to analyse quantitative data collected from participating sites and complementary qualitative data on Zio utilisation from questionnaires

Conditions

Cardiology; Stroke/TIA

Outcome Measures

Primary Outcomes (3)

• Time to device being fitted

  Time to device being fitted

  6 months

• Time to diagnosis

  Time to diagnosis

  6 months

• Time to treatment decision

  Time to treatment decision - referral for anticoagulant prescription or other clinical intervention, where needed

  6 months

Secondary Outcomes (14)

• Resource utilisation

  6 months

• Time to ECG report

  6 months

• Time to repeat ambulatory ECG test referrals

  6 months

• Number of insertable cardiac monitors such as LINQ implants

  6 months

• Number of hospital visits

  6 months

Study Arms (2)

Zio Cohort

Patients who have been prescribed Zio

Other: Zio XT service

Holter Cohort

Patients who have been prescribed Holter

Interventions

Zio XT service OTHER

There will be no intervention. Standard of care at participating NHS organizations will not be affected.

Zio Cohort

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

Two cohorts will be recruited from a cardiology and stroke/TIA population

You may qualify if:

• Data from stroke/TIA population:
• years of age or older
• diagnosed with having had an ischaemic non-lacunar stroke or probable TIA by a stroke clinician or neurologist.
• Referred for ambulatory ECG monitoring
• Data from cardiology population:
• years of age or older
• experiencing symptomatic palpitations, dizziness, pre-syncope or syncope
• Referred for ambulatory ECG monitoring
• Qualitative data will be collected via self-administered questionnaires from healthcare professionals who:
• are involved in prescribing the Zio XT service, fitting the Zio patch, interpreting the Zio report and making a treatment decision.
• Qualitative data will be collected via self-administered questionnaires from patients who:
• are 18 years of age or older
• have been prescribed the Zio patch
• have been prescribed the Zio patch and the Holter monitor (within two years)

You may not qualify if:

• Data from stroke/TIA population:
• History of AF or atrial flutter
• \> 50% stenosis of a potentially symptomatic cervical artery (carotid or vertebral)
• Pre-existing indication or contraindication for permanent anticoagulation therapy
• Significant uncertainty of TIA diagnosis such as cases where TIA treatment isn't initiated
• New lacunar stroke reported on imaging which corresponds to the presenting stroke syndrome
• Data from cardiology population:
• Patients in whom 24-hour monitoring is required due to the following reasons:
• experiencing daily symptoms
• the need for AF rate control measurement
• the need for ectopic burden measurement
• Patients who are prescribed Implantable Loop Recorders and pacemakers in situ

Sponsors & Collaborators

• King's College London: lead

Central Study Contacts

Anna Barnes

CONTACT

020 784 89527; anna.barnes@kcl.ac.uk

Sarah Hammoudi

CONTACT

020 784 89527; sarah.hammoudi@kcl.ac.uk

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 16, 2022
• First Posted: September 29, 2022
• Study Start: October 31, 2022
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: September 29, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share