Home Electronic Monitoring of Chronic Heart Failure (MEDIC)

Monitoring Electronique à Distance Des Patients Insuffisants Cardiaques

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

Study Overview

• Status: Unknown
• Conditions: Chronic Heart Failure
• Intervention / Treatment: Device: telemonitoring of weight, pulse and blood pressure

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 210
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Besançon, France
    • Recruiting
    • CHU de Besançon
    • Contact: Marie-France Seronde

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients with chronic heart failure, NYHA II, III or IV
• Patients with follow-up in therapeutic education program and who had finish the program in 2011, 2012, 2013, 2014, 2015, 2016, 2017
• Information given and informed consent given

Exclusion Criteria:

• vital emergencies
• Refusal of patient, cardiologist or general practitioner
• Person who is not able to communicate or answer the questions
• Patients with problems of understanding as such dure to those diseases : dementia, Alzheimer disease, or neurological sequelae of cerebral stroke
• Patients who do not speak french
• Patients under guardianship
• Patients with other diseases which alter quality of life
• Patients who participate to another clinical trial
• Person private of liberty by court decision

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: telemonitoring; telemonitoring of weight, arterial pressure and heart rate at home with connection to a medical platform to monitor the evolution.	Device: telemonitoring of weight, pulse and blood pressure
No Intervention: conventional follow-up

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of rehospitalizations due to acute heart failure and number of death due to heart failure	1 year

Secondary Outcome Measures

Outcome Measure	Time Frame
Number and cost of consultations, treatments, hospitalization, transport, care of nurses ...	1 year
Qualitative interviews of patients and to all medical care services about uses and services rendered by the new device	1 year
Interviews of patients and comptability of alarms of non-observance of weight, pulse and arterial pressure measure to evaluate acceptability and observance of telemonitoring device	1 year
Scores on questionnaires of minnesota, EQ-5D and IADL to evaluate quality of life and autonomy	1 year
Mean duration of stay during hospitalization	1 year
Number of hospitalization in emergency care unit to measure efficacy of telemonitoring	1 year
Number of alarm for increase of weight, hypo- or hypertension, bradycardia or tachycardia as a measure of efficacy of telemonitoring	1 year

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Besancon
• Collaborators: AG2R La Mondiale; IMRI; AFPEC; H2AD; Pôle des Microtechniques de Besançon

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2015
• Primary Completion (Anticipated): September 1, 2020
• Study Completion (Anticipated): September 1, 2020

Study Registration Dates

• First Submitted: June 1, 2015
• First Submitted That Met QC Criteria: June 29, 2015
• First Posted (Estimate): July 1, 2015

Study Record Updates

• Last Update Posted (Actual): July 18, 2018
• Last Update Submitted That Met QC Criteria: July 17, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Keywords: telemonitoring
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: P/2014/234