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

Terminated

• Conditions: Residents of Retirement Home (EHPAD); Cardiac Pathology

• Registration Number: NCT04357405
• Lead Sponsor: Gérond'if

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.

Study Timeline

• Study Start: 2019-06-06
• Study First Submitted: 2020-04-16
• Study First Submitted QC: 2020-04-21
• Study First Posted: 2020-04-22
• Primary Completion: 2020-07-07
• Study Completion: 2021-04-08
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-27
• Last Update Posted: 2022-09-29

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 430

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Assessment of teletransmetted electrocardiogram (ECG) feasability (number of ECGs interpretable)	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.	12 months	The prevalence of anomalies highlighted by performing an electrocardiogram: supra-ventricular rhythm disorders, ventricular rhythm disorder and coronary pathologies.

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Psychiatric Geriatric Department, Broca hospital; 🇫🇷 Paris, Ile-de-France, France