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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
DOUBLE
Enrollment
225
Participants receive a seven-day ECG Holter after hospital discharge.
Participants receive a 24-hour blood pressure monitor, approximately four weeks after hospital discharge.
Participants receive a questionnaire concerning their vision of mHealth, approximately four weeks after hospital discharge.
Ziekenhuist Oost-Limburg
Genk, Limburg, Belgium
RECRUITINGJessa Hospital
Hasselt, Limburg, Belgium
RECRUITINGAF detection with mHealth versus ILR - Percentage
Percentage of patients with AF detected
Time frame: After 6 months of having an ILR inserted and using mHealth.
AF detection with ILR - Percentage
Percentage of patients with AF detected
Time frame: After 12 months of having an ILR inserted.
AF detection with mHealth versus ILR - Time to first AF detection
Time to first AF detection
Time frame: Baseline until end of study (after 12 months of having an ILR inserted).
AF detection with mHealth versus ILR - Frequency
Frequency of AF episodes
Time frame: Baseline until end of study (after 12 months of having an ILR inserted).
AF detection with mHealth versus ILR - Duration
Duration of AF episodes
Time frame: 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
Time frame: 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
Time frame: Baseline until end of study (after 12 months of having an ILR inserted).
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Participants receive a questionnaire concerning their user experience and feeling of safety of using mHealth, after using mHealth for six months.
Participants receive an insertable loop recorder, approximately six weeks after hospital discharge.
Correlation between follow-up characteristics and AF detection
Follow-up characteristics include changes in therapy, number of relevant readmissions, mortality and healthcare-related costs
Time frame: Baseline until end of study (after 12 months of having an ILR inserted).