the Dutch-GERAF Study (GERAF)

February 19, 2024 updated by: Dijklander Ziekenhuis

The Dutch Multicentre Study Into Opportunistically Screening Geriatric Patients for Atrial Fibrillation Using a PPG Smartphone App; the Dutch-GERAF Study

Geriatric patients are at high risk of cardiovascular complications, and for the development of atrial fibrillation. Often atrial fibrillation exists in these patients without specific symptoms, and could therefore remain unknown. Furthermore, concerns exist about the bleeding profile of anticoagulation in the very elderly or frail patients.

This study applies opportunistic screening for atrial fibrillation as advised in the latest ESC Guideline on the diagnosis and management of atrial fibrillation. Furthermore, multiple bleeding risk scores will be applies, to better assess the bleeding risk in very elderly or frail patients.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

1075

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Netherlands
      • Alkmaar, Netherlands, 1815 JD
        • Noordwest Ziekenhuisgroep
      • Amersfoort, Netherlands, 3813 TZ
        • Meander Medisch Centrum
      • Amsterdam, Netherlands, 1091 AC
        • Onze Lieve Vrouwe Gasthuis
      • Dordrecht, Netherlands, 3318 AT
        • Albert Schweitzer Ziekenhuis
    • Gelderland
      • Arnhem, Gelderland, Netherlands, 6815 AD
        • Rijnstate
    • Noord-Holland
      • Hoorn, Noord-Holland, Netherlands, 1624NP
        • Dijklander ziekenhuis

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

All newly referred patients of 65 years and older that visit a geriatric outpatient service. These will form a cohort of very elderly individuals, with multi morbidity, polypharmacy, cognitive disorders, high frailty and high risk for falling. They can also be seen as a group at high risk of cardiovascular complication and/or the development of cognitive disorders.

Description

Inclusion Criteria:

All newly referred patients of 65 years and older that visit geriatric outpatient services are eligible (including Fall clinic, Memory clinic, Pre-operative geriatric assessment clinic, or any other geriatric outpatient clinics that are led by a geriatrician).

Exclusion Criteria:

  • The patient has a pacemaker or implantable cardioverter defibrillator.
  • The patient is known with a severe dementia, MoCA ≤ 15 points.
  • The patient has a severe tremor, from whatever cause, and thus is unable to use the PPG based smartphone AF detection algorithm.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Newly identified cases of atrial fibrillation
Time Frame: The first 6 months after recruitment for the study
PPG or ECG detected new cases of atrial fibrillation
The first 6 months after recruitment for the study

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Major bleeding
Time Frame: From recruitment until 3 years after the recruitment of the last participant
Major bleeding, including intra cranial haemorrhage
From recruitment until 3 years after the recruitment of the last participant
Stroke
Time Frame: From recruitment until 3 years after the recruitment of the last participant
Stroke
From recruitment until 3 years after the recruitment of the last participant
Death
Time Frame: From recruitment until 3 years after the recruitment of the last participant
Death
From recruitment until 3 years after the recruitment of the last participant
Cognitive disorder
Time Frame: From recruitment until 3 years after the recruitment of the last participant
Development of dementia, categorized by aetiology, during follow up
From recruitment until 3 years after the recruitment of the last participant
New Atrial Fibrillation, developed after the screening period
Time Frame: From recruitment until 3 years after the recruitment of the last participant
New Atrial Fibrillation, developed after the screening period
From recruitment until 3 years after the recruitment of the last participant

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dijklander Ziekenhuis

Investigators

  • Principal Investigator: René Jansen, PhD, Northwest Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 25, 2021

Primary Completion (Actual)

October 26, 2022

Study Completion (Estimated)

June 30, 2026

Study Registration Dates

First Submitted

April 13, 2022

First Submitted That Met QC Criteria

April 13, 2022

First Posted (Actual)

April 20, 2022

Study Record Updates

Last Update Posted (Actual)

February 20, 2024

Last Update Submitted That Met QC Criteria

February 19, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WB 694

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Upon reasonable request, anonymized data could be shared after approval of all principal investigators

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Atrial Fibrillation

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Jamaica

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe