A photoplethysmography-based smartphone app (FibriCheck) to detect atrial fibrillation after stroke or transient ischemic attack: a prospective interventional study

Not Applicable

• Conditions: Atrial Fibrillation; Cardiovascular - Other cardiovascular diseases; Stroke; Transient Ischemic Attack; Stroke - Ischaemic

• Registration Number: ACTRN12621001547831
• Lead Sponsor: The University of Adelaide

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-11-12
• Last Update Posted: 22 November 2021

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 196

Inclusion Criteria

Patients with a recent (<30 days) ischemic stroke undergoing non-invasive heart rhythm monitoring (either Holter monitoring or ‘Heartbug’)
- Aged 18 years or older
- Owner of a smartphone

Exclusion Criteria

- Intracerebral haemorrhage (this does not include haemorrhagic transformation of an ischemic stroke)
- Known history of atrial fibrillation
- Pacemaker
- High probability of a known stroke aetiology such that heart rhythm monitoring is not clinically necessary
- Cognitive impairment or dysphasia precluding effective use of the App
- Inability to install the app in the smartphone or to use it

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcome will be any detection of AF in stroke/TIA patients by the FibriCheck app within one month of monitoring.[Assessed three times per day for 1 month post-enrolment];The primary outcome will be any detection of AF in stroke/TIA patients by continuous monitoring for one month using Holter monitor/Heartbug[Assessed at 1 month post-enrolment]

Secondary Outcome Measures

Name	Time	Method
The ease of use of the app as reported by the participants via a questionnaire.<br>This will be assessed using a 5-point Likert scale based on questions in the following domains: difficulty in using the app, general satisfaction, feeling of safety/reassurance, physician relationship<br>[Assessed at 1 month post-enrolment];The compliance to the planned PPG measurements (thrice daily for 1 month) assessed by accessing the app analytics (number of measurements recorded versus number of measurements planned or expected)[Assessed at 1 month post-enrolment ];The secondary outcome will be any detection of AF in stroke/TIA patients by the FibriCheck app within three months of monitoring.[Assessed three times per day for 3 months post-enrolment];The compliance to the planned PPG measurements (thrice daily for 3months) assessed by accessing the app analytics (number of measurements recorded versus number of measurements planned or expected)[Assessed at 3 months post-enrolment ]