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| Name | Class |
|---|---|
| Hasselt University | OTHER |
| Jessa Hospital | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PPG-based mHealth on smartphone | Experimental | 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. |
|
| PPG-based mHealth on smartwatch | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| seven-day ECG Holter | Device | Participants receive a seven-day ECG Holter after hospital discharge. |
|
| 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. |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| David Verhaert, Dr. | Contact | +3289 32 70 91 | david.verhaert@zol.be | |
| Femke Wouters | Contact | femke.wouters@zol.be |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ziekenhuist Oost-Limburg | Recruiting | Genk | Limburg | 3600 | Belgium |
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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.
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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.
| 24-hour blood pressure monitor | Device | Participants receive a 24-hour blood pressure monitor, approximately four weeks after hospital discharge. |
|
| Questionnaire: vision of mHealth | Other | Participants receive a questionnaire concerning their vision of mHealth, approximately four weeks after hospital discharge. |
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| Questionnaire: user experience & feeling of safety | Other | Participants receive a questionnaire concerning their user experience and feeling of safety of using mHealth, after using mHealth for six months. |
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| Insertable loop recorder | Device | Participants receive an insertable loop recorder, approximately six weeks after hospital discharge. |
|
| 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). |
| Jessa Hospital | Recruiting | Hasselt | Limburg | 3500 | Belgium |
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| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D015716 | Electrocardiography, Ambulatory |
| D015924 | Blood Pressure Monitors |
| ID | Term |
|---|---|
| D004562 | Electrocardiography |
| D006334 | Heart Function Tests |
| D003935 | Diagnostic Techniques, Cardiovascular |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D004568 | Electrodiagnosis |
| D018670 | Monitoring, Ambulatory |
| D008991 | Monitoring, Physiologic |
| D019722 | Sphygmomanometers |
| D019719 | Diagnostic Equipment |
| D004864 | Equipment and Supplies |
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