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Clinical Trials/NCT04357405
NCT04357405
Terminated
Not Applicable

Study of the Interest of ECG Teletransmission in Retirement Home (EHPAD) In the Ile-de-France Region.

Gérond'if1 site in 1 country430 target enrollmentJune 6, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cardiac Pathology
Sponsor
Gérond'if
Enrollment
430
Locations
1
Primary Endpoint
Assessment of teletransmetted electrocardiogram (ECG) feasability (number of ECGs interpretable)
Status
Terminated
Last Updated
3 years ago

Overview

Brief Summary

The aim of the study is to evaluate the interest and the workability of ECG teletranmission in EHPAD in Île-de-France. ECG for the elderly is beneficial to detect or monitor cardiovascular disease.

Detailed Description

Main objectives : * Evaluate the workability of ECG uploaded by a caregiver who was trained before * Evaluate the prevalence of ECG anomalies highlighted thanks to the realisation of an uploaded ECG (supraventricular and ventricular rhythm disorder and coronary pathology) Secondaries objectives : * Evaluate the prevalence of unknown ECG anomalies and thus determine the number of new diagnostics highlighted thanks to uploaded ECG * Evaluate the prevalence of ECG iatrogenic anomalies The study is observational, multicentre and prospective. It is going to include 3211 elderly living in EHPAD in Île-de-France. 150 EHPAD or involved in the study, they are split in two groups : 100 EHPAD will receive ECG and 50 EHPAD will not. This last group will enable to lead a comparative analysis, only global data about death will be collected. The study will last 36 months with 12 months of participation for each resident.

Registry
clinicaltrials.gov
Start Date
June 6, 2019
End Date
April 8, 2021
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Gérond'if
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Elderly living in nursing homes (EHPAD) who requires electrocadiogram (ECG) due to :
  • Cardiac pathology : coronary artery disease, heart failure, high blood pressure, diabetes, valvular disease, atrial fibrillation
  • A medication which could causes electrocadiogram (ECG) anomalies Patients living in nursing homes (EHPAD) who give their agreement.
  • Exclusion criteria :
  • Protected adult under a protection of the court

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Assessment of teletransmetted electrocardiogram (ECG) feasability (number of ECGs interpretable)

Time Frame: 12 months

An interpretable ECG is defined by an absence of parasite, a stable baseline, an absence of argument of a malposition of electrodes, an unwinding paper speed: 25 mm / sec, a calibration of the amplitude

Assessment of prevalence of anomalies highlighted by performing an electrocardiogram.

Time Frame: 12 months

The prevalence of anomalies highlighted by performing an electrocardiogram: supra-ventricular rhythm disorders, ventricular rhythm disorder and coronary pathologies.

Secondary Outcomes

  • Assessment of commorbidity risk and life expectancy according Charlson score.(12 months)
  • Assessment of prevalence of unknown and iatrogenic anomalies according to the electrocardiogram(12 months)

Study Sites (1)

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