Atrial Fibrillation, Cryptogenic Stroke
Conditions
Keywords
Mobile health, Prolonged cardiac monitoring, Photoplethysmography
Brief summary
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
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.
Interventions
DEVICEseven-day ECG Holter
Participants receive a seven-day ECG Holter after hospital discharge.
DEVICE24-hour blood pressure monitor
Participants receive a 24-hour blood pressure monitor, approximately four weeks after hospital discharge.
OTHERQuestionnaire: vision of mHealth
Participants receive a questionnaire concerning their vision of mHealth, approximately four weeks after hospital discharge.
OTHERQuestionnaire: 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.
DEVICEInsertable loop recorder
Participants receive an insertable loop recorder, approximately six weeks after hospital discharge.
Sponsors
Hasselt University
Jessa Hospital
Ziekenhuis Oost-Limburg
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
DOUBLE (Subject, Caregiver)
Masking description
The participant and care provider are not blinded for which mHealth method is used (smartphone or smartwatch), but are blinded for the mHealth results (i.e., AF detection) during the monitoring period with the mHealth application.
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| AF detection with mHealth versus ILR - Percentage | After 6 months of having an ILR inserted and using mHealth. | Percentage of patients with AF detected |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| AF detection with mHealth versus ILR - Time to first AF detection | Baseline until end of study (after 12 months of having an ILR inserted). | Time to first AF detection |
| AF detection with mHealth versus ILR - Frequency | Baseline until end of study (after 12 months of having an ILR inserted). | Frequency of AF episodes |
| AF detection with mHealth versus ILR - Duration | Baseline until end of study (after 12 months of having an ILR inserted). | Duration of AF episodes |
| AF detection with ILR - Percentage | After 12 months of having an ILR inserted. | Percentage of patients with AF detected |
| Correlation between baseline characteristics and AF detection | Baseline until end of study (after 12 months of having an ILR inserted). | Baseline characteristics include comorbidities, results of standard of care in-hospital stroke examinations and scores, relevant in-hospital therapy |
| Correlation between follow-up characteristics and AF detection | Baseline until end of study (after 12 months of having an ILR inserted). | Follow-up characteristics include changes in therapy, number of relevant readmissions, mortality and healthcare-related costs |
| User experience and feeling of safety questionnaire | After 6 months of having an ILR inserted and using mHealth. | Questionnaire with a 7 point Likert scale |
Countries
Belgium
Contacts
Primary ContactDavid Verhaert, Dr.
Backup ContactFemke Wouters
Outcome results
None listed