NCT05006105

Brief Summary

The purpose of this study is to demonstrate the added value of mobile health (mHealth) to detect atrial fibrillation (AF) early in the care path of cryptogenic stroke and transient ischemic attack (TIA) patients.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
225

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 12, 2020

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

July 13, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 16, 2021

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2025

Completed
Last Updated

September 16, 2022

Status Verified

September 1, 2022

Enrollment Period

4.3 years

First QC Date

July 13, 2021

Last Update Submit

September 14, 2022

Conditions

Cryptogenic StrokeAtrial Fibrillation

Keywords

Mobile healthProlonged cardiac monitoringPhotoplethysmography

Outcome Measures

Primary Outcomes (1)

  • AF detection with mHealth versus ILR - Percentage

    Percentage of patients with AF detected

    After 6 months of having an ILR inserted and using mHealth.

Secondary Outcomes (7)

  • AF detection with ILR - Percentage

    After 12 months of having an ILR inserted.

  • AF detection with mHealth versus ILR - Time to first AF detection

    Baseline until end of study (after 12 months of having an ILR inserted).

  • AF detection with mHealth versus ILR - Frequency

    Baseline until end of study (after 12 months of having an ILR inserted).

  • AF detection with mHealth versus ILR - Duration

    Baseline until end of study (after 12 months of having an ILR inserted).

  • User experience and feeling of safety questionnaire

    After 6 months of having an ILR inserted and using mHealth.

  • +2 more secondary outcomes

Study Arms (2)

PPG-based mHealth on smartphone

EXPERIMENTAL

Participants used PPG-based mHealth on a smartphone for 6 months. Participants were asked to perform two spot-check measurements and additional measurements in case of symptoms. The use of PPG-based mHealth on a smartphone was initiated on the day of insertable loop recorder insertion.

Device: seven-day ECG HolterDevice: 24-hour blood pressure monitorOther: Questionnaire: vision of mHealthOther: Questionnaire: user experience & feeling of safetyDevice: Insertable loop recorder

PPG-based mHealth on smartwatch

EXPERIMENTAL

Participants used PPG-based mHealth on a smartwatch for 6 months. Participants were asked to wear the smartwatch continuously (except during battery charging). The use of PPG-based mHealth on a smartwatch was initiated on the day of insertable loop recorder insertion.

Device: seven-day ECG HolterDevice: 24-hour blood pressure monitorOther: Questionnaire: vision of mHealthOther: Questionnaire: user experience & feeling of safetyDevice: Insertable loop recorder

Interventions

seven-day ECG HolterDEVICE

Participants receive a seven-day ECG Holter after hospital discharge.

PPG-based mHealth on smartphonePPG-based mHealth on smartwatch
24-hour blood pressure monitorDEVICE

Participants receive a 24-hour blood pressure monitor, approximately four weeks after hospital discharge.

PPG-based mHealth on smartphonePPG-based mHealth on smartwatch
Questionnaire: vision of mHealthOTHER

Participants receive a questionnaire concerning their vision of mHealth, approximately four weeks after hospital discharge.

PPG-based mHealth on smartphonePPG-based mHealth on smartwatch
Questionnaire: user experience & feeling of safetyOTHER

Participants receive a questionnaire concerning their user experience and feeling of safety of using mHealth, after using mHealth for six months.

PPG-based mHealth on smartphonePPG-based mHealth on smartwatch
Insertable loop recorderDEVICE

Participants receive an insertable loop recorder, approximately six weeks after hospital discharge.

PPG-based mHealth on smartphonePPG-based mHealth on smartwatch

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of cryptogenic ischemic stroke or TIA
  • The patient or its legal representative is willing to sign the informed consent

You may not qualify if:

  • History of AF or atrial flutter
  • Life expectancy of less than one year
  • Not qualified for ILR insertion
  • Indication or contraindication for permanent oral anticoagulants (OAC) at enrolment
  • Untreated hyperthyroidism
  • Myocardial infarction or coronary bypass grafting less than one month before the stroke onset
  • Presence of patent foramen ovale (PFO) and it is or was an indication to start OAC according to the European Stroke Organization guidelines
  • Not able to understand the Dutch language
  • Patient or partner not in possession of a smartphone

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Ziekenhuist Oost-Limburg

Genk, Limburg, 3600, Belgium

RECRUITING

Jessa Hospital

Hasselt, Limburg, 3500, Belgium

RECRUITING

MeSH Terms

Conditions

Ischemic StrokeAtrial Fibrillation

Interventions

Electrocardiography, AmbulatoryBlood Pressure Monitors

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesArrhythmias, CardiacHeart DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

ElectrocardiographyHeart Function TestsDiagnostic Techniques, CardiovascularDiagnostic Techniques and ProceduresDiagnosisElectrodiagnosisMonitoring, AmbulatoryMonitoring, PhysiologicSphygmomanometersDiagnostic EquipmentEquipment and Supplies

Central Study Contacts

David Verhaert, Dr.

CONTACT

+3289 32 70 91david.verhaert@zol.be

Femke Wouters

CONTACT

femke.wouters@zol.be

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Masking Details
The participant and care provider are not blinded for which mHealth method is used (smartphone or smartwatch), but are blinded for the mHealth results (i.e., AF detection) during the monitoring period with the mHealth application.
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Model Details: Group 1 uses PPG-based mHealth with a smartphone; two times a day, a spot-check measurement is taken; and in case of symptoms, additional measurements can be taken. Group 2 uses PPG-based mHealth with a smartwatch, this results in semi-continuous measurements that are performed automatically.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

July 13, 2021

First Posted

August 16, 2021

Study Start

October 12, 2020

Primary Completion

February 1, 2025

Study Completion

February 1, 2025

Last Updated

September 16, 2022

Record last verified: 2022-09

Locations

BE(2)