Early Detection of Atrial Fibrillation Using Mobile Technology in Cryptogenic Stroke Patients

Study Overview
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Brief Summary
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The purpose of this study is to demonstrate the added value of mobile health (mHealth) to detect atrial fibrillation (AF) early in the care path of cryptogenic stroke and transient ischemic attack (TIA) patients.

Detailed Description
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The use of photoplethysmography (PPG)-based mHealth (with smartphone and smartwatch) is compared to the guideline-recommended insertable loop recorders (ILR) in the detection of AF in cryptogenic stroke or TIA patients.

Official Title
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Early Detection of Atrial Fibrillation Using Mobile Technology in Cryptogenic Stroke Patients - REMOTE Study

Conditions
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Cryptogenic Stroke, Atrial Fibrillation

Intervention / Treatment
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* Device: seven-day ECG Holter
* Device: 24-hour blood pressure monitor
* Other: Questionnaire: vision of mHealth
* Other: Questionnaire: user experience & feeling of safety
* Device: Insertable loop recorder


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of cryptogenic ischemic stroke or TIA The patient or its legal representative is willing to sign the informed consent Exclusion Criteria: History of AF or atrial flutter Life expectancy of less than one year Not qualified for ILR insertion Indication or contraindication for permanent oral anticoagulants (OAC) at enrolment Untreated hyperthyroidism Myocardial infarction or coronary bypass grafting less than one month before the stroke onset Presence of patent foramen ovale (PFO) and it is or was an indication to start OAC according to the European Stroke Organization guidelines Inclusion in another clinical trial that will affect the objectives of this study Not able to understand the Dutch language Patient or partner not in possession of a smartphone

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Group 1 uses PPG-based mHealth with a smartphone; two times a day, a spot-check measurement is taken; and in case of symptoms, additional measurements can be taken. Group 2 uses PPG-based mHealth with a smartwatch, this results in semi-continuous measurements that are performed automatically.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PPG-based mHealth on smartphone<br>Participants used PPG-based mHealth on a smartphone for 6 months. Participants were asked to perform two spot-check measurements and additional measurements in case of symptoms. The use of PPG-based mHealth on a smartphone was initiated on the day of insertable loop recorder insertion. | Device: seven-day ECG Holter<br>* Participants receive a seven-day ECG Holter after hospital discharge.<br>Device: 24-hour blood pressure monitor<br>* Participants receive a 24-hour blood pressure monitor, approximately four weeks after hospital discharge.<br>Other: Questionnaire: vision of mHealth<br>* Participants receive a questionnaire concerning their vision of mHealth, approximately four weeks after hospital discharge.<br>Other: Questionnaire: user experience & feeling of safety<br>* Participants receive a questionnaire concerning their user experience and feeling of safety of using mHealth, after using mHealth for six months.<br>Device: Insertable loop recorder<br>* Participants receive an insertable loop recorder, approximately six weeks after hospital discharge.<br>|
| Experimental: PPG-based mHealth on smartwatch<br>Participants used PPG-based mHealth on a smartwatch for 6 months. Participants were asked to wear the smartwatch continuously (except during battery charging). The use of PPG-based mHealth on a smartwatch was initiated on the day of insertable loop recorder insertion. | Device: seven-day ECG Holter<br>* Participants receive a seven-day ECG Holter after hospital discharge.<br>Device: 24-hour blood pressure monitor<br>* Participants receive a 24-hour blood pressure monitor, approximately four weeks after hospital discharge.<br>Other: Questionnaire: vision of mHealth<br>* Participants receive a questionnaire concerning their vision of mHealth, approximately four weeks after hospital discharge.<br>Other: Questionnaire: user experience & feeling of safety<br>* Participants receive a questionnaire concerning their user experience and feeling of safety of using mHealth, after using mHealth for six months.<br>Device: Insertable loop recorder<br>* Participants receive an insertable loop recorder, approximately six weeks after hospital discharge.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AF detection with mHealth versus ILR - Percentage | Percentage of patients with AF detected | After 6 months of having an ILR inserted and using mHealth. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AF detection with ILR - Percentage | Percentage of patients with AF detected | After 12 months of having an ILR inserted. | 
| AF detection with mHealth versus ILR - Time to first AF detection | Time to first AF detection | Baseline until end of study (after 12 months of having an ILR inserted). | 
| AF detection with mHealth versus ILR - Frequency | Frequency of AF episodes | Baseline until end of study (after 12 months of having an ILR inserted). | 
| AF detection with mHealth versus ILR - Duration | Duration of AF episodes | Baseline until end of study (after 12 months of having an ILR inserted). | 
| User experience and feeling of safety questionnaire | Questionnaire with a 7 point Likert scale | After 6 months of having an ILR inserted and using mHealth. | 
| Correlation between baseline characteristics and AF detection | Baseline characteristics include comorbidities, results of standard of care in-hospital stroke examinations and scores, relevant in-hospital therapy | Baseline until end of study (after 12 months of having an ILR inserted). | 
| Correlation between follow-up characteristics and AF detection | Follow-up characteristics include changes in therapy, number of relevant readmissions, mortality and healthcare-related costs | Baseline until end of study (after 12 months of having an ILR inserted). | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prolonged cardiac monitoring, Photoplethysmography, Mobile health