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Early Detection of Atrial Fibrillation Using Mobile Technology in Cryptogenic Stroke Patients (REMOTE)

Primary Purpose

Cryptogenic Stroke, Atrial Fibrillation

Status
Recruiting
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
seven-day ECG Holter
24-hour blood pressure monitor
Questionnaire: vision of mHealth
Questionnaire: user experience & feeling of safety
Insertable loop recorder
Sponsored by
Ziekenhuis Oost-Limburg
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Cryptogenic Stroke focused on measuring Mobile health, Prolonged cardiac monitoring, Photoplethysmography

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • 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
  • Inclusion in another clinical trial that will affect the objectives of this study
  • Not able to understand the Dutch language
  • Patient or partner not in possession of a smartphone

Sites / Locations

  • Ziekenhuist Oost-LimburgRecruiting
  • Jessa HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

PPG-based mHealth on smartphone

PPG-based mHealth on smartwatch

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

AF detection with mHealth versus ILR - Percentage
Percentage of patients with AF detected

Secondary Outcome Measures

AF detection with ILR - Percentage
Percentage of patients with AF detected
AF detection with mHealth versus ILR - Time to first AF detection
Time to first AF detection
AF detection with mHealth versus ILR - Frequency
Frequency of AF episodes
AF detection with mHealth versus ILR - Duration
Duration of AF episodes
User experience and feeling of safety questionnaire
Questionnaire with a 7 point Likert scale
Correlation between baseline characteristics and AF detection
Baseline characteristics include comorbidities, results of standard of care in-hospital stroke examinations and scores, relevant in-hospital therapy
Correlation between follow-up characteristics and AF detection
Follow-up characteristics include changes in therapy, number of relevant readmissions, mortality and healthcare-related costs

Full Information

First Posted
July 13, 2021
Last Updated
September 14, 2022
Sponsor
Ziekenhuis Oost-Limburg
Collaborators
Hasselt University, Jessa Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05006105
Brief Title
Early Detection of Atrial Fibrillation Using Mobile Technology in Cryptogenic Stroke Patients
Acronym
REMOTE
Official Title
Early Detection of Atrial Fibrillation Using Mobile Technology in Cryptogenic Stroke Patients - REMOTE Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 12, 2020 (Actual)
Primary Completion Date
February 2025 (Anticipated)
Study Completion Date
February 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ziekenhuis Oost-Limburg
Collaborators
Hasselt University, Jessa Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
The use of photoplethysmography (PPG)-based mHealth (with smartphone and smartwatch) is compared to the guideline-recommended insertable loop recorders (ILR) in the detection of AF in cryptogenic stroke or TIA patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cryptogenic Stroke, Atrial Fibrillation
Keywords
Mobile health, Prolonged cardiac monitoring, Photoplethysmography

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
ParticipantCare Provider
Masking Description
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.
Allocation
Randomized
Enrollment
225 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PPG-based mHealth on smartphone
Arm Type
Experimental
Arm Description
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.
Arm Title
PPG-based mHealth on smartwatch
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
seven-day ECG Holter
Intervention Description
Participants receive a seven-day ECG Holter after hospital discharge.
Intervention Type
Device
Intervention Name(s)
24-hour blood pressure monitor
Intervention Description
Participants receive a 24-hour blood pressure monitor, approximately four weeks after hospital discharge.
Intervention Type
Other
Intervention Name(s)
Questionnaire: vision of mHealth
Intervention Description
Participants receive a questionnaire concerning their vision of mHealth, approximately four weeks after hospital discharge.
Intervention Type
Other
Intervention Name(s)
Questionnaire: user experience & feeling of safety
Intervention Description
Participants receive a questionnaire concerning their user experience and feeling of safety of using mHealth, after using mHealth for six months.
Intervention Type
Device
Intervention Name(s)
Insertable loop recorder
Intervention Description
Participants receive an insertable loop recorder, approximately six weeks after hospital discharge.
Primary Outcome Measure Information:
Title
AF detection with mHealth versus ILR - Percentage
Description
Percentage of patients with AF detected
Time Frame
After 6 months of having an ILR inserted and using mHealth.
Secondary Outcome Measure Information:
Title
AF detection with ILR - Percentage
Description
Percentage of patients with AF detected
Time Frame
After 12 months of having an ILR inserted.
Title
AF detection with mHealth versus ILR - Time to first AF detection
Description
Time to first AF detection
Time Frame
Baseline until end of study (after 12 months of having an ILR inserted).
Title
AF detection with mHealth versus ILR - Frequency
Description
Frequency of AF episodes
Time Frame
Baseline until end of study (after 12 months of having an ILR inserted).
Title
AF detection with mHealth versus ILR - Duration
Description
Duration of AF episodes
Time Frame
Baseline until end of study (after 12 months of having an ILR inserted).
Title
User experience and feeling of safety questionnaire
Description
Questionnaire with a 7 point Likert scale
Time Frame
After 6 months of having an ILR inserted and using mHealth.
Title
Correlation between baseline characteristics and AF detection
Description
Baseline characteristics include comorbidities, results of standard of care in-hospital stroke examinations and scores, relevant in-hospital therapy
Time Frame
Baseline until end of study (after 12 months of having an ILR inserted).
Title
Correlation between follow-up characteristics and AF detection
Description
Follow-up characteristics include changes in therapy, number of relevant readmissions, mortality and healthcare-related costs
Time Frame
Baseline until end of study (after 12 months of having an ILR inserted).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of cryptogenic ischemic stroke or TIA The patient or its legal representative is willing to sign the informed consent Exclusion Criteria: 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 Inclusion in another clinical trial that will affect the objectives of this study Not able to understand the Dutch language Patient or partner not in possession of a smartphone
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
David Verhaert, Dr.
Phone
+3289 32 70 91
Email
david.verhaert@zol.be
First Name & Middle Initial & Last Name or Official Title & Degree
Femke Wouters
Email
femke.wouters@zol.be
Facility Information:
Facility Name
Ziekenhuist Oost-Limburg
City
Genk
State/Province
Limburg
ZIP/Postal Code
3600
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Verhaert, Dr.
Email
david.verhaert@zol.be
First Name & Middle Initial & Last Name & Degree
Femke Wouters, MSc
Email
femke.wouters@uhasselt.be
First Name & Middle Initial & Last Name & Degree
David Verhaert, Dr.
Facility Name
Jessa Hospital
City
Hasselt
State/Province
Limburg
ZIP/Postal Code
3500
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thomas Phlips, Dr.
Email
thomas.phlips@jessazh.be
First Name & Middle Initial & Last Name & Degree
Femke Wouters, MSc
Email
femke.wouters@uhasselt.be
First Name & Middle Initial & Last Name & Degree
Thomas Phlips, Dr.

12. IPD Sharing Statement

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Early Detection of Atrial Fibrillation Using Mobile Technology in Cryptogenic Stroke Patients

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