Home Electronic Monitoring of Chronic Heart Failure (MEDIC)

Centre Hospitalier Universitaire de Besancon

Status: Unknown

Conditions: Chronic Heart Failure

Treatments: Device: telemonitoring of weight, pulse and blood pressure

Study type: Interventional

Funder types: Other

Identifiers

NCT02486887

P/2014/234

Details and patient eligibility

About

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

Full 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.

Enrollment: 210 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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210 participants in 2 patient groups

telemonitoring

Experimental group

Description:

telemonitoring of weight, arterial pressure and heart rate at home with connection to a medical platform to monitor the evolution.

Treatment:

Device: telemonitoring of weight, pulse and blood pressure

conventional follow-up

No Intervention group

Description:

conventional follow-up