CardiologyNCT05560828
Zio Real-World Evaluation
An observational study of Cardiology and Stroke/TIA, run by King's College London.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiology, Stroke/TIA
- What is being tested?
- Zio XT service
- How many people
- 1,440 participants
- Where
- No sites listed yet
- Study dates
- 31 Oct 2022to 31 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Two cohorts will be recruited from a cardiology and stroke/TIA population
Who may be able to join
- Data from stroke/TIA population:
- 18 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:
- 18 years of age or older
Show all 14Show fewer
- 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)
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official 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
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
Read the detailed description
The proposed study is a multi-centre, cohort study that will collect 6-month control data from a cohort of participants wearing Holter devices (2018-2019) and match this data to a 6-month cohort of patients wearing Zio patches (2021 - 2022). An additional cohort of patients using the Zio patch from both the cardiology and stroke/TIA population will be included for the patient experience aspect of the study.
Other designs have been considered but from a pragmatic point of view and the need for a "real-world" evaluation this is the preferred alternative with the caveat that there may not be an exact match between the two patient groups.
The proposed study is a multi-centre, cohort study that will collect 6-month baseline data from a retrospective cohort of participants wearing Holter devices and match this data to a 6-month retrospective cohort of patients wearing Zio patches. 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.
Two separate populations will be considered for this study: cardiology outpatients and patients at risk of (or who have had a previous) stroke or TIA. Each of these populations will comprise a control cohort for Holter monitor and a cohort for Zio service, which will be analysed separately. A separate cohort comprising of participants prescribed Zio will be included in a qualitative analysis to assess their experience of using Zio and previous experience of using Holter monitor within the past 2 years, where applicable. This will allow for a comparative analysis of patient experience. For patients in the cohort who have not had prior experience of using Holter monitor, a questionnaire will be administered to assess their experience of using Zio only.
Given the potential for a shift in the spectrum of the population that may be expected when Zio is implemented, propensity score matching will be utilised to compare the Holter and Zio cohorts for both the stroke/TIA and cardiology arms.
- Conditions
- Cardiology, Stroke/TIA
- Being tested
- Zio XT service
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zio XT serviceOther
There will be no intervention. Standard of care at participating NHS organizations will not be affected.
| Study group | Role | What they receive |
|---|---|---|
| Zio Cohort | Patients who have been prescribed Zio Receives: Other: Zio XT service | |
| Holter Cohort | Patients who have been prescribed Holter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to device being fitted
Time to device being fitted
Measured: 6 months
Time to diagnosis
Time to diagnosis
Measured: 6 months
Time to treatment decision
Time to treatment decision - referral for anticoagulant prescription or other clinical intervention, where needed
Measured: 6 months
Secondary outcomes (14)
Resource utilisation
Resource utilisation
Measured: 6 months
Time to ECG report
Time to ECG report
Measured: 6 months
Time to repeat ambulatory ECG test referrals
Time to repeat ambulatory ECG test referrals
Measured: 6 months
Number of insertable cardiac monitors such as LINQ implants
Number of insertable cardiac monitors such as LINQ implants
Measured: 6 months
Number of hospital visits
Number of hospital visits
Measured: 6 months
Number of inconclusive follow-up appointments
Number of inconclusive follow-up appointments
Measured: 6 months
Number of device failures / adverse events
Number of device failures / adverse events
Measured: 6 months
Proportion of patients that undergo full monitoring following referral
Proportion of patients that undergo full monitoring following referral
Measured: 6 months
Diagnostic yield
Diagnostic yield
Measured: 6 months
"Rule out"
"Rule out" - number of patients with non-clinically significant arrhythmia
Measured: 6 months
Time to discharge of patients with non-clinically significant cardiac arrhythmia
Time to discharge of patients with non-clinically significant cardiac arrhythmia
Measured: 6 months
Settlement of patient's GP surgery - urban or rural area
Settlement of patient's GP surgery - urban or rural area
Measured: 6 months
Patient experience
Patient experience of using Zio
Measured: 6 months
Clinical experience of using Zio
Clinical experience of using Zio
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2022
- Study start31 Oct 2022 (estimated)
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CardiologyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 1,440 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05560828
- Sponsor's protocol ID
- KCLAI001
- Status last verified
- Aug 2022
- First submitted
- 16 Aug 2022
- Last updated
- 29 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No IPD will be shared
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT05560828
- Acronym / sponsor ID
- KCLAI001
- Conditions
- Cardiology, Stroke/TIA
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,440 participants (estimated)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Study start
- 31 Oct 2022 (estimated)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 29 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
The proposed study is a multi-centre, cohort study that will collect 6-month control data from a cohort of participants wearing Holter devices (2018-2019) and match this data to a 6-month cohort of patients wearing Zio patches (2021 - 2022). An additional cohort of patients using the Zio patch from both the cardiology and stroke/TIA population will be included for the patient experience aspect of the study.
Other designs have been considered but from a pragmatic point of view and the need for a "real-world" evaluation this is the preferred alternative with the caveat that there may not be an exact match between the two patient groups.
The proposed study is a multi-centre, cohort study that will collect 6-month baseline data from a retrospective cohort of participants wearing Holter devices and match this data to a 6-month retrospective cohort of patients wearing Zio patches. 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.
Two separate populations will be considered for this study: cardiology outpatients and patients at risk of (or who have had a previous) stroke or TIA. Each of these populations will comprise a control cohort for Holter monitor and a cohort for Zio service, which will be analysed separately. A separate cohort comprising of participants prescribed Zio will be included in a qualitative analysis to assess their experience of using Zio and previous experience of using Holter monitor within the past 2 years, where applicable. This will allow for a comparative analysis of patient experience. For patients in the cohort who have not had prior experience of using Holter monitor, a questionnaire will be administered to assess their experience of using Zio only.
Given the potential for a shift in the spectrum of the population that may be expected when Zio is implemented, propensity score matching will be utilised to compare the Holter and Zio cohorts for both the stroke/TIA and cardiology arms.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Zio Cohort | – | Other: Zio XT servicePatients who have been prescribed Zio |
| Holter Cohort | – | –Patients who have been prescribed Holter |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Two cohorts will be recruited from a cardiology and stroke/TIA population
Key inclusion criteria (14 listed)
- 18 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
- 18 years of age or older
- experiencing symptomatic palpitations, dizziness, pre-syncope or syncope
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Zio XT serviceThere will be no intervention. Standard of care at participating NHS organizations will not be affected. | Other | Zio Cohort |
Primary outcome
Time to device being fitted
Time frame: 6 months
Time to device being fitted
Time to diagnosis
Time frame: 6 months
Time to diagnosis
Time to treatment decision
Time frame: 6 months
Time to treatment decision - referral for anticoagulant prescription or other clinical intervention, where needed
14 secondary outcomes
Resource utilisation
Time frame: 6 months
Time to ECG report
Time frame: 6 months
Time to repeat ambulatory ECG test referrals
Time frame: 6 months
Number of insertable cardiac monitors such as LINQ implants
Time frame: 6 months
Number of hospital visits
Time frame: 6 months
Number of inconclusive follow-up appointments
Time frame: 6 months
Number of device failures / adverse events
Time frame: 6 months
Proportion of patients that undergo full monitoring following referral
Time frame: 6 months
Diagnostic yield
Time frame: 6 months
"Rule out"
Time frame: 6 months
Time to discharge of patients with non-clinically significant cardiac arrhythmia
Time frame: 6 months
Settlement of patient's GP surgery - urban or rural area
Time frame: 6 months
Patient experience
Time frame: 6 months
Clinical experience of using Zio
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2022.
- Individual participant dataSharing planned: No. No IPD will be shared
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiology and Stroke/TIA, run by King's College London.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anna Barnes (020 784 89527, anna.barnes@kcl.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to device being fitted (time frame: 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2022.