The Smartphone and Wearable Detected Atrial Arrhythmia in Older Adults Case Finding Study (Smart in OAC - AFNET 9)
- Conditions
- Atrial Arrhythmia
- Interventions
- Device: Preventicus heartbeat app in combination with wearables
- Registration Number
- NCT04579159
- Lead Sponsor
- Atrial Fibrillation Network
- Brief Summary
This feasibility study will develop and evaluate pathways to identify participants with wearable-detected absoulute Arrhythmia (AA) and to enable local study teams to contact them regarding participation in a controlled trial of oral anticoagulation in this population, which will be conducted after the feasibility study.
- Detailed Description
In this study, the feasibility of evaluating the efficacy of a cloud based analytic service in combination with a PPG-wearable in detecting AA will be assessed and the number of cases found. The design aims to provide simple, low-threshold access to this screening technology targeting at-risk populations. This study will not cause any restrictions on the usual care of the study participants. Access to the screening will be provided close to home and free of charge. The app will also be used to validate and enhance the clinical information about the participants captured during the study. This information will be used to define and refine target groups with highest screening efficiency and, in the long-term, outcome benefits. The study will describe the prevalence of AA in an unselected population that can be reached by a low-threshold screening procedure. The study will also generate important information on the different possible screening environments in different countries (e.g. pharmacies, GP practices, etc). Structures of work-up and continuous patient management in screen-positive individuals will be described and may help to design screening pathways in the main trial. By verifying the wearable-diagnoses by ECG in all screen-positive and a random selection of screen-negative participants, the diagnostic accuracy of the wearable in combination of cloud based analytic service can be estimated. Cost effectiveness assessment will evaluate the cost of low-threshold remote screening per patient identified and help guide to target high risk groups with optimal screening yield in the future. The collected data will provide the sound basis for the design and conduct of a large outcome trial.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 882
Inclusion criteria:
- 65 years or older
- Willing and able to provide informed consent
- Owning mobile phone compatible with the PPG-wearable
Exclusion criteria:
- Known AF
- Known current or planned oral anticoagulation treatment
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description only control group Preventicus heartbeat app in combination with wearables To investigate the specificity of the wearable and to gather more information on ECG abnormalities in the population studied, a randomly selected group of participants without wearable-detected AA within 8 weeks of screening (same number as screen-positives and verified by Telecare) will also be invited to obtain a 14day Tele ECG (patch).
- Primary Outcome Measures
Name Time Method Proportion of participants with newly detected AA within 4 weeks of device use of all participants included in the study Screening per participant: 4-8 weeks Proportion of participants with newly detected AA within 4 weeks of device use of all participants included in the study
- Secondary Outcome Measures
Name Time Method Differences by rout fo invitation and enrolment Screening per participant: 4-8 weeks ECG screening: 2 weeks Overall study duration: 12 months Differences by rout fo invitation and enrolment
Follow-up EQ-5DL-5L viscual analogue scale of participants with positve PPG Screening per participant: 4-8 weeks ECG screening: 2 weeks Overall study duration: 12 months Follow-up EQ-5DL-5L viscual analogue scale of participants with positve PPG
Propotion of participants with AA detected at any time, including those with AA detected within the full time of recording Screening per participant: 4-8 weeks ECG screening: 2 weeks Overall study duration: 12 months Propotion of participants with AA detected at any time, including those with AA detected within the full time of recording
Time from completed enrolment to the first positive screening, taking death as compeeting risk into account Screening per participant: 4-8 weeks ECG screening: 2 weeks Overall study duration: 12 months Time from completed enrolment to the first positive screening, taking death as compeeting risk into account
Duration of atrial arrhythmia episodes Screening per participant: 4-8 weeks ECG screening: 2 weeks Overall study duration: 12 months Duration of atrial arrhythmia episodes will be reported descriptively by mean, sd, range, median and IQR
Compliance: The compliance of participants with protocol with regards to the measurement procedure of the app and wearable Screening per participant: 4-8 weeks ECG screening: 2 weeks Overall study duration: 12 months Compliance: The compliance of participants with protocol with regards to the measurement procedure of the app and wearable will be presented descriptively
Regional differences of AA prevalance (diagnostic yield) Screening per participant: 4-8 weeks ECG screening: 2 weeks Overall study duration: 12 months Regional differences of AA prevalance (diagnostic yield)
Detection of AF: Number of participants with clinically confirmed arrhythmias during Holter ECG Screening per participant: 4-8 weeks ECG screening: 2 weeks Overall study duration: 12 months Detection of AF: Number of participants with clinically confirmed arrhythmias during Holter ECG, documented clinically or by event-recorder
Trial Locations
- Locations (4)
Universitäres Herz- und Gefäßzentrum UKE Hamburg
🇩🇪Hamburg, Germany
Kardiologische Praxis, Dr. med. Jens Taggeselle
🇩🇪Markkleeberg, Germany
Krakowskie Centrum Diagnostyczno-Kliniczne (KCDK)
🇵🇱Kraków, Poland
Hospital Clínic Unitat d'Arrítmies, Institut Cardiovascular
🇪🇸Barcelona, Catalonia, Spain