Clinical trial NCT02486887: Home Electronic Monitoring of Chronic Heart Failure
Official title: Monitoring Electronique à Distance Des Patients Insuffisants Cardiaques
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Heart Failure
Keywords: telemonitoring
Lead sponsor: Centre Hospitalier Universitaire de Besancon
Sponsor class: OTHER
Collaborators: name: AG2R La Mondiale
name: IMRI
name: AFPEC
name: H2AD
name: Pôle des Microtechniques de Besançon
First posted: 2015-07-01
Enrollment: 210
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of rehospitalizations due to acute heart failure and number of death due to heart failure
timeFrame: 1 year
Secondary outcomes:
measure: Number and cost of consultations, treatments, hospitalization, transport, care of nurses ...
timeFrame: 1 year
measure: Qualitative interviews of patients and to all medical care services about uses and services rendered by the new device
timeFrame: 1 year
measure: 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
timeFrame: 1 year
measure: Scores on questionnaires of minnesota, EQ-5D and IADL to evaluate quality of life and autonomy
timeFrame: 1 year
measure: Mean duration of stay during hospitalization
timeFrame: 1 year
measure: Number of hospitalization in emergency care unit to measure efficacy of telemonitoring
timeFrame: 1 year
measure: Number of alarm for increase of weight, hypo- or hypertension, bradycardia or tachycardia as a measure of efficacy of telemonitoring
timeFrame: 1 year
Other outcomes:
Locations:
city: Besançon
country: France
facility: CHU de Besançon
Study officials:
References: