Home Electronic Monitoring of Chronic Heart Failure — MEDIC  

Chronic Heart Failure Clinical Trial

Official title: Monitoring Electronique à Distance Des Patients Insuffisants Cardiaques

Status Recruiting

Clinical Trial Summary

The main objective of the study is to evaluate the effect of telemonitoring on mortality and rehospitalization due to heart failure on patients with chronic heart failure which have follow an educational program compared to a conventional follow-up during 1 year.

The secondary objectives of the study are :

• Evaluate the cost of health

• Qualitatively evaluate telemonitoring on uses

• Evaluate quality of life

Clinical Trial Description

prospective, monocentric, randomized open-labeled study.

1. - Data collected

1. - during inclusion visit sex, age, full contact details, marital status, number of child, level of education, professional status weight, height, BMI, cardiac pulse, blood pressure, NYHA, consumption of tobacco and alcohol, concomitant treatments, medical history BNP, prealbumin Quality of life questionnaire (Minnesota), Depression questionnaire (HAD), autonomy questionnaire (IADL)

2. - at 6 month weight, height, BMI, cardiac pulse, blood pressure, NYHA, consumption of tobacco and alcohol, concomitant treatments, medical history BNP, prealbumin Number of consultations, nurses care, number of hospitalization in emergency care unit, number of hospitalization due to acute heart failure, number of days of hospitalization, number of medical transports Quality of life questionnaire (Minnesota), Depression questionnaire (HAD), autonomy questionnaire (IADL)

3. - at one year weight, height, BMI, cardiac pulse, blood pressure, NYHA, consumption of tobacco and alcohol, concomitant treatments, medical history BNP, prealbumin Number of consultations, nurses care, number of hospitalization in emergency care unit, number of hospitalization due to acute heart failure, number of days of hospitalization, number of medical transports Quality of life questionnaire (Minnesota), Depression questionnaire (HAD), autonomy questionnaire (IADL)

2. - Medico-economic evaluation The objective of this evaluation is to analyzed the efficiency of telemonitoring in patients with chronic heart failure.

This evaluation has to be :

• quantitative : directs modifications of cost and nature of health care follow-up or organization

• qualitative : indirect impact on health care costs of situations or behavior

3. - study of uses "uses" is faculty of recognition, comprehension, use, appropriation and diversion of the telemonitoring by patients.

During the first phase, interviews to obtain qualitative vision of interactions between telemonitoring and ecosystems of players.

40 qualitative interviews during 2 hours of : 30 patients ; 24 users of telemonitoring and 6 non-users. 10 members of medical and paramedical staff The objectives of the second phase is to defined usage scenarios from previous assessments.

4.- Telemonitoring surveillance of weight, blood pressure and cardiac pulse, 3 times a week by the patient at home.

H2AD platform, general practitioner, cardiology unit, therapeutical education team had to manage alarms.

The devices (balance, blood pressure and pulse monitor) are related by GPRS to a medical platform. The platform receive every measure of weight, blood pressure and pulse. When weight, blood pressure or pulse increased or decreased, alarms are emitted and patients are contacted by a practitioner. ;

Related Conditions & MeSH terms

• Chronic Heart Failure
• Heart Failure

• NCT number: NCT02486887
• Study type: Interventional
• Source: Centre Hospitalier Universitaire de Besancon
• Contact: Seronde Marie-France, PH
• Phone: 0033381668185
• Email: mfseronde@chu-besancon.fr
• Status: Recruiting
• Phase: N/A
• Start date: June 2015
• Completion date: September 2020