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| Name | Class |
|---|---|
| European Union | OTHER |
| Preventicus GmbH | INDUSTRY |
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In the RedStroke study, the effect of a smartphone application in detecting Atrial Fibrillation (AF) will be assessed in a double-blind randomised controlled multicenter trial. Outpatients with an elevated risk for atrial fibrillation will be randomized to an intervention arm (app group) and to a standard-of-care arm (control group). Both groups will have the app installed on their private smartphones and will be asked to perform a predefined measurement protocol. All patients will continue their prior therapy with their general practitioner and obtain every medical treatment indicated. This study will not cause any restrictions on the usual treatment of the study patients.
The only difference between the two groups will be, that patients in the app group will be informed by their local PI, if the recordings of the app indicate AF (and obtain a 14 day Holter ECG for AF verification), whereas the patients in the "usual care" group will obtain the read out of the app at the end of the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| App Group | Experimental | In the app group, if an episode of arrhythmia is detected with the app, the local investigator will contact the respective patient to schedule an appointment for a 14 day Holter ECG. |
|
| Standard Care Group | Other | The control group will perform the same measurements as the intervention group, with the only difference that a cumulated Portable Document Format (PDF) report is provided after 6 months instead of the immediate feedback in the app group. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| App measurement | Device | App measurement twice a day in the first two weeks after enrollment and twice a week (on different days) from the third week onward and whenever patients feel palpitations |
| Measure | Description | Time Frame |
|---|---|---|
| Prevalence of Atrial Fibrillation | Prevalence of Atrial Fibrillation confirmed by ECG in the app group compared with the standard care group | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Costs related to the AF screening | Health care resource utilization data related to AF diagnosis will be collected for all patients during the study. To evaluate the clinical consequences associated with screening, additional endpoints include the initiation of AF-related therapies including anticoagulants, antiarrhythmic agents or hospitalizations with a primary diagnosis of AF. As a general measure of health care utilization, hospitalization for any cause will also be evaluated. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jens Eckstein, MD, PhD | University Hospital, Basel, Switzerland | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Medicine Greifswald | Greifswald | Mecklenburg-Vorpommern | 17475 | Germany | ||
| Ambulantes Herz-Kreislauf-Zentrum |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| D006333 | Heart Failure |
| D020521 | Stroke |
| D003920 | Diabetes Mellitus |
| D014652 | Vascular Diseases |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D015716 | Electrocardiography, Ambulatory |
| ID | Term |
|---|---|
| D004562 | Electrocardiography |
| D006334 | Heart Function Tests |
| D003935 | Diagnostic Techniques, Cardiovascular |
| D019937 | Diagnostic Techniques and Procedures |
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In this study, the effect of a smartphone application in detecting AF will be assessed in a double-blind randomised controlled trial. Patients will be randomized to an intervention arm (app group) and to a standard-of-care arm (control group). Both groups will have the app installed on their private smartphones and will be asked to perform a predefined measurement protocol. The only difference between the two groups will be, that patients in the "app" group will be informed by their local PI, if the recordings of the app indicate AF, whereas the patients in the "usual care" group will obtain the read out of the app at the end of the study (6 months after inclusion).
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Patients and study team will remain blind to the assigned groups until the end of the trial. Only in case of a positive app finding, patients and site team will be unblinded for the remaining time of the trial.
| 14 day Holter ECG | Device | 14 day moblie patch Holter ECG for AF confirmation |
|
| 6 months |
| Compliance of patients using the app | Number of patients who regularly use the app according to study instructions | 6 months |
| Pasewalk |
| 17309 |
| Germany |
| Asklepeion Hospital | Athens | Attica | 17121 | Greece |
| Semmelweis University - Heart and Vascular Center | Budapest | 1122 | Hungary |
| University Maastricht Polikliniek Hart+Vaat Centrum | Maastricht | Limburg | 6200 MD | Netherlands |
| Jagiellonian University Medical College | Krakow | Lesser Poland Voivodeship | 31-501 | Poland |
| Universitiy Hospital Basel | Basel | Canton of Basel-City | 4031 | Switzerland |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D003933 | Diagnosis |
| D004568 | Electrodiagnosis |
| D018670 | Monitoring, Ambulatory |
| D008991 | Monitoring, Physiologic |