Home Electronic Monitoring of Chronic Heart Failure

Chronic Heart Failure Clinical Trial

— MEDIC  

Official title:

Monitoring Electronique à Distance Des Patients Insuffisants Cardiaques

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02486887
• Other study ID #: P/2014/234
• Status: Recruiting
• Phase: N/A
• Start date: June 2015
• Est. completion date: September 2020

Study information

• Verified date: July 2018
• Source: Centre Hospitalier Universitaire de Besancon
• Contact: Seronde Marie-France, PH
• Phone: 0033381668185
• Email: mfseronde[@]chu-besancon.fr
• Is FDA regulated: No
• Study type: Interventional

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 210
• Est. completion date: September 2020
• Est. primary completion date: September 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Heart Failure
• Heart Failure

Intervention

Device:
• telemonitoring of weight, pulse and blood pressure

Locations

Country	Name	City	State
France	CHU de Besançon	Besançon

Sponsors (6)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Besancon	AFPEC, AG2R La Mondiale, H2AD, IMRI, Pôle des Microtechniques de Besançon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of rehospitalizations due to acute heart failure and number of death due to heart failure		1 year
Secondary	Number and cost of consultations, treatments, hospitalization, transport, care of nurses ...		1 year
Secondary	Qualitative interviews of patients and to all medical care services about uses and services rendered by the new device		1 year
Secondary	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
Secondary	Scores on questionnaires of minnesota, EQ-5D and IADL to evaluate quality of life and autonomy		1 year
Secondary	Mean duration of stay during hospitalization		1 year
Secondary	Number of hospitalization in emergency care unit to measure efficacy of telemonitoring		1 year
Secondary	Number of alarm for increase of weight, hypo- or hypertension, bradycardia or tachycardia as a measure of efficacy of telemonitoring		1 year