Atrial Fibrillation
Conditions
Keywords
Atrial Fibrillation, Smartphone App, CHA2DS2-VASc-Score, Screening, Cardiovascular risk factors, Outpatient setting, Congestive heart failure, Stroke, Diabetes, Vascular disease
Brief summary
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.
Interventions
DEVICEApp measurement
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
DEVICE14 day Holter ECG
14 day moblie patch Holter ECG for AF confirmation
Sponsors
European Union
Preventicus GmbH
University Hospital, Basel, Switzerland
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
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.
Intervention model description
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).
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* written informed consent * CHA2DS2-VASc score of 3 and above, if patients are aged under 65 years * CHA2DS2-VASc score of 2 and above, if patients are aged 65 years or older
Exclusion criteria
* history of Atrial Fibrillation * current anticoagulation treatment, * cardiac implanted electronic device (ICD or/and PM) * app cannot be installed due to technical problems (smartphone type, reduced smartphone storage capacity, other) * inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant * enrollment of the investigator, his/her family members, employees and other dependent persons
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Prevalence of Atrial Fibrillation | 6 months | Prevalence of Atrial Fibrillation confirmed by ECG in the app group compared with the standard care group |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Costs related to the AF screening | 6 months | 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. |
| Compliance of patients using the app | 6 months | Number of patients who regularly use the app according to study instructions |
Countries
Germany, Greece, Hungary, Netherlands, Poland, Switzerland
Outcome results
None listed