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

Residents of Retirement Home (EHPAD) Clinical Trial

— TEECAD  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04357405
• Other study ID #: 2017-A02647-46
• Status: Terminated
• Start date: June 6, 2019
• Est. completion date: April 8, 2021

Study information

• Verified date: September 2022
• Source: Gérond'if
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 430
• Est. completion date: April 8, 2021
• Est. primary completion date: July 7, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiac Pathology
• Residents of Retirement Home (EHPAD)

Locations

Country	Name	City	State
France	Psychiatric Geriatric Department, Broca hospital	Paris	Ile-de-France

Sponsors (1)

Lead Sponsor	Collaborator
Gérond'if

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of teletransmetted electrocardiogram (ECG) feasability (number of ECGs interpretable)	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	12 months
Primary	Assessment of prevalence of anomalies highlighted by performing an electrocardiogram.	The prevalence of anomalies highlighted by performing an electrocardiogram: supra-ventricular rhythm disorders, ventricular rhythm disorder and coronary pathologies.	12 months
Secondary	Assessment of commorbidity risk and life expectancy according Charlson score.		12 months
Secondary	Assessment of prevalence of unknown and iatrogenic anomalies according to the electrocardiogram		12 months