Early Detection of Atrial Fibrillation Using Mobile Technology in Cryptogenic Stroke Patients
NCT ID: NCT05006105
Last Updated: 2022-09-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
225 participants
INTERVENTIONAL
2020-10-12
2025-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
Group 2 uses PPG-based mHealth with a smartwatch, this results in semi-continuous measurements that are performed automatically.
DIAGNOSTIC
DOUBLE
Study Groups
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PPG-based mHealth on smartphone
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.
seven-day ECG Holter
Participants receive a seven-day ECG Holter after hospital discharge.
24-hour blood pressure monitor
Participants receive a 24-hour blood pressure monitor, approximately four weeks after hospital discharge.
Questionnaire: vision of mHealth
Participants receive a questionnaire concerning their vision of mHealth, approximately four weeks after hospital discharge.
Questionnaire: user experience & feeling of safety
Participants receive a questionnaire concerning their user experience and feeling of safety of using mHealth, after using mHealth for six months.
Insertable loop recorder
Participants receive an insertable loop recorder, approximately six weeks after hospital discharge.
PPG-based mHealth on smartwatch
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.
seven-day ECG Holter
Participants receive a seven-day ECG Holter after hospital discharge.
24-hour blood pressure monitor
Participants receive a 24-hour blood pressure monitor, approximately four weeks after hospital discharge.
Questionnaire: vision of mHealth
Participants receive a questionnaire concerning their vision of mHealth, approximately four weeks after hospital discharge.
Questionnaire: user experience & feeling of safety
Participants receive a questionnaire concerning their user experience and feeling of safety of using mHealth, after using mHealth for six months.
Insertable loop recorder
Participants receive an insertable loop recorder, approximately six weeks after hospital discharge.
Interventions
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seven-day ECG Holter
Participants receive a seven-day ECG Holter after hospital discharge.
24-hour blood pressure monitor
Participants receive a 24-hour blood pressure monitor, approximately four weeks after hospital discharge.
Questionnaire: vision of mHealth
Participants receive a questionnaire concerning their vision of mHealth, approximately four weeks after hospital discharge.
Questionnaire: user experience & feeling of safety
Participants receive a questionnaire concerning their user experience and feeling of safety of using mHealth, after using mHealth for six months.
Insertable loop recorder
Participants receive an insertable loop recorder, approximately six weeks after hospital discharge.
Eligibility Criteria
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Inclusion Criteria
* The patient or its legal representative is willing to sign the informed consent
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Hasselt University
OTHER
Jessa Hospital
OTHER
Ziekenhuis Oost-Limburg
OTHER
Responsible Party
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David Verhaert, MD
Dr.
Locations
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Ziekenhuist Oost-Limburg
Genk, Limburg, Belgium
Jessa Hospital
Hasselt, Limburg, Belgium
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CTU2019106
Identifier Type: -
Identifier Source: org_study_id
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