The Smartphone and Wearable Detected Atrial Arrhythmia in Older Adults Case Finding Study (Smart in OAC - AFNET 9)

Study Overview
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Brief Summary
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This feasibility study will develop and evaluate pathways to identify participants with wearable-detected absoulute Arrhythmia (AA) and to enable local study teams to contact them regarding participation in a controlled trial of oral anticoagulation in this population, which will be conducted after the feasibility study.

Detailed Description
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In this study, the feasibility of evaluating the efficacy of a cloud based analytic service in combination with a PPG-wearable in detecting AA will be assessed and the number of cases found. The design aims to provide simple, low-threshold access to this screening technology targeting at-risk populations. This study will not cause any restrictions on the usual care of the study participants. Access to the screening will be provided close to home and free of charge. The app will also be used to validate and enhance the clinical information about the participants captured during the study. This information will be used to define and refine target groups with highest screening efficiency and, in the long-term, outcome benefits. The study will describe the prevalence of AA in an unselected population that can be reached by a low-threshold screening procedure. The study will also generate important information on the different possible screening environments in different countries (e.g. pharmacies, GP practices, etc). Structures of work-up and continuous patient management in screen-positive individuals will be described and may help to design screening pathways in the main trial. By verifying the wearable-diagnoses by ECG in all screen-positive and a random selection of screen-negative participants, the diagnostic accuracy of the wearable in combination of cloud based analytic service can be estimated. Cost effectiveness assessment will evaluate the cost of low-threshold remote screening per patient identified and help guide to target high risk groups with optimal screening yield in the future. The collected data will provide the sound basis for the design and conduct of a large outcome trial.

Official Title
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Multicentre, Intern., Inv.-Initiated, Single-arm Case-finding Study of a Cloud Based Analytic Service as Screening Tool to Detect and Quantify Episodes of Absolute Arrhythmia Using an Automated, Wearable PPG-based Monitoring System

Conditions
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Atrial Arrhythmia

Intervention / Treatment
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* Device: Preventicus heartbeat app in combination with wearables


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Inclusion criteria: 65 years or older Willing and able to provide informed consent Owning mobile phone compatible with the PPG-wearable Exclusion criteria: Known AF Known current or planned oral anticoagulation treatment

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: only control group<br>To investigate the specificity of the wearable and to gather more information on ECG abnormalities in the population studied, a randomly selected group of participants without wearable-detected AA within 8 weeks of screening (same number as screen-positives and verified by Telecare) will also be invited to obtain a 14day Tele ECG (patch). | Device: Preventicus heartbeat app in combination with wearables<br>* CE certified devices<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of participants with newly detected AA within 4 weeks of device use of all participants included in the study | Proportion of participants with newly detected AA within 4 weeks of device use of all participants included in the study | Screening per participant: 4-8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Propotion of participants with AA detected at any time, including those with AA detected within the full time of recording | Propotion of participants with AA detected at any time, including those with AA detected within the full time of recording | Screening per participant: 4-8 weeks ECG screening: 2 weeks Overall study duration: 12 months | 
| Time from completed enrolment to the first positive screening, taking death as compeeting risk into account | Time from completed enrolment to the first positive screening, taking death as compeeting risk into account | Screening per participant: 4-8 weeks ECG screening: 2 weeks Overall study duration: 12 months | 
| Regional differences of AA prevalance (diagnostic yield) | Regional differences of AA prevalance (diagnostic yield) | Screening per participant: 4-8 weeks ECG screening: 2 weeks Overall study duration: 12 months | 
| Differences by rout fo invitation and enrolment | Differences by rout fo invitation and enrolment | Screening per participant: 4-8 weeks ECG screening: 2 weeks Overall study duration: 12 months | 
| Duration of atrial arrhythmia episodes | Duration of atrial arrhythmia episodes will be reported descriptively by mean, sd, range, median and IQR | Screening per participant: 4-8 weeks ECG screening: 2 weeks Overall study duration: 12 months | 
| Follow-up EQ-5DL-5L viscual analogue scale of participants with positve PPG | Follow-up EQ-5DL-5L viscual analogue scale of participants with positve PPG | Screening per participant: 4-8 weeks ECG screening: 2 weeks Overall study duration: 12 months | 
| Detection of AF: Number of participants with clinically confirmed arrhythmias during Holter ECG | Detection of AF: Number of participants with clinically confirmed arrhythmias during Holter ECG, documented clinically or by event-recorder | Screening per participant: 4-8 weeks ECG screening: 2 weeks Overall study duration: 12 months | 
| Compliance: The compliance of participants with protocol with regards to the measurement procedure of the app and wearable | Compliance: The compliance of participants with protocol with regards to the measurement procedure of the app and wearable will be presented descriptively | Screening per participant: 4-8 weeks ECG screening: 2 weeks Overall study duration: 12 months |