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

September 27, 2022 updated by: Gérond'if
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.

Study Overview

Status

Terminated

Conditions

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 Type

Observational

Enrollment (Actual)

430

Contacts and Locations

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

Study Locations

  • France
    • Ile-de-France
      • Paris, Ile-de-France, France, 75013
        • Psychiatric Geriatric Department, Broca hospital

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

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients living in nursing homes (EHPAD) requiring an electrocadiogram (ECG) except emergency situation, due to a cardiac pathology with / or without treatment which can lead to ECG abnormalities

Description

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

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

Cohorts and Interventions

Group / Cohort
Experimental arm
This group consists of 100 EHPAD which will benefit from ECG teletransmission. all data will be collected
Control arm
This arm consists of 50 EHPAD that have not benefited from ECG teletransmission. Only the global death occurrence data will be analyzed, no individual data will be collected.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
12 months
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.
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Assessment of commorbidity risk and life expectancy according Charlson score.
Time Frame: 12 months
12 months
Assessment of prevalence of unknown and iatrogenic anomalies according to the electrocardiogram
Time Frame: 12 months
12 months

Collaborators and Investigators

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

Sponsor

Gérond'if

Investigators

  • Study Chair: Olivier Hanon, MD PhD, Psychiatric Geriatric Department, Broca hospital

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)

June 6, 2019

Primary Completion (Actual)

July 7, 2020

Study Completion (Actual)

April 8, 2021

Study Registration Dates

First Submitted

April 16, 2020

First Submitted That Met QC Criteria

April 21, 2020

First Posted (Actual)

April 22, 2020

Study Record Updates

Last Update Posted (Actual)

September 29, 2022

Last Update Submitted That Met QC Criteria

September 27, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2017-A02647-46

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.

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