RedStroke - Reducing Europe's Stroke Incidence

NCT04108884 | Completed

• 1 other identifier: 2019-00908
• Study Type: interventional
• Target: 1,019
• Locations: 6 countries
• Sites: 7

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.

Conditions

Atrial Fibrillation

Keywords

Atrial Fibrillation; Smartphone App; CHA2DS2-VASc-Score; Screening; Cardiovascular risk factors; Outpatient setting; Congestive heart failure; Stroke; Diabetes; Vascular disease

Outcome Measures

Primary Outcomes (1)

• Prevalence of Atrial Fibrillation

  Prevalence of Atrial Fibrillation confirmed by ECG in the app group compared with the standard care group

  6 months

Secondary Outcomes (2)

• Costs related to the AF screening

  6 months

• Compliance of patients using the app

  6 months

Study Arms (2)

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.

Device: App measurement; Device: 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.

Device: App measurement

Interventions

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

App Group; Standard Care Group

14 day Holter ECG DEVICE

14 day moblie patch Holter ECG for AF confirmation

App Group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead
• European Union: collaborator
• Preventicus GmbH: collaborator

Study Sites (7)

University Medicine Greifswald

Greifswald, Mecklenburg-Vorpommern, 17475, Germany

Location

Ambulantes Herz-Kreislauf-Zentrum

Pasewalk, 17309, Germany

Location

Asklepeion Hospital

Athens, Attica, 17121, Greece

Location

Semmelweis University - Heart and Vascular Center

Budapest, 1122, Hungary

Location

University Maastricht Polikliniek Hart+Vaat Centrum

Maastricht, Limburg, 6200 MD, Netherlands

Location

Jagiellonian University Medical College

Krakow, Lesser Poland Voivodeship, 31-501, Poland

Location

Universitiy Hospital Basel

Basel, Canton of Basel-City, 4031, Switzerland

Location

MeSH Terms

Conditions

Atrial Fibrillation; Heart Failure; Stroke; Diabetes Mellitus; Vascular Diseases

Interventions

Electrocardiography, Ambulatory

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Electrocardiography; Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Electrodiagnosis; Monitoring, Ambulatory; Monitoring, Physiologic

Study Officials

• Jens Eckstein, MD, PhD

  University Hospital, Basel, Switzerland

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: 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.
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: September 26, 2019
• First Posted: September 30, 2019
• Study Start: October 22, 2019
• Primary Completion: January 18, 2024
• Study Completion: January 18, 2024
• Last Updated: May 17, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

HU (1); NL (1); DE (2); GR (1); PL (1); CH (1)