Clinical trial NCT04357405: Study of the Interest of ECG Teletransmission in Retirement Home (EHPAD) In the Ile-de-France Region.
Official title: Study of the Interest of ECG Teletransmission in Retirement Home (EHPAD) In the Ile-de-France Region.
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Cardiac Pathology
Residents of Retirement Home (EHPAD)
Keywords: ECG
Elderly EHPAD's resident
Cardiac desease
Lead sponsor: Gérond'if
Sponsor class: OTHER
First posted: 2020-04-22
Enrollment: 430
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.

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

Primary outcomes:
measure: Assessment of teletransmetted electrocardiogram (ECG) feasability (number of ECGs interpretable)
timeFrame: 12 months
measure: Assessment of prevalence of anomalies highlighted by performing an electrocardiogram.
timeFrame: 12 months
Secondary outcomes:
measure: Assessment of commorbidity risk and life expectancy according Charlson score.
timeFrame: 12 months
measure: Assessment of prevalence of unknown and iatrogenic anomalies according to the electrocardiogram
timeFrame: 12 months
Other outcomes:
Locations:
city: Paris
country: France
facility: Psychiatric Geriatric Department, Broca hospital
state: Ile-de-France
Study officials:
affiliation: Psychiatric Geriatric Department, Broca hospital
name: Olivier Hanon, MD PhD
role: STUDY_CHAIR
References: