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Zio Real-World Evaluation

NCT05560828 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 1440

Last updated 2022-09-29

No results posted yet for this study

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

Interventions

OTHER

Zio XT service

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

Sponsors & Collaborators

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-31
Primary Completion
2022-12-31
Completion
2022-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05560828 on ClinicalTrials.gov