Home Electronic Monitoring of Chronic Heart Failure

NCT ID: NCT02486887

Last Updated: 2018-07-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 210 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-06-30
• Study Completion Date: 2020-09-30

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.

Conditions

Chronic Heart Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

telemonitoring

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

Group Type: EXPERIMENTAL

telemonitoring of weight, pulse and blood pressure

Intervention Type: DEVICE

conventional follow-up

conventional follow-up

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

telemonitoring of weight, pulse and blood pressure

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AG2R La Mondiale

OTHER

Sponsor Role: collaborator

IMRI

UNKNOWN

Sponsor Role: collaborator

AFPEC

UNKNOWN

Sponsor Role: collaborator

H2AD

OTHER

Sponsor Role: collaborator

Pôle des Microtechniques de Besançon

UNKNOWN

Sponsor Role: collaborator

Centre Hospitalier Universitaire de Besancon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CHU de Besançon

Besançon, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Seronde Marie-France, PH

Role: CONTACT

mfseronde@chu-besancon.fr

0033381668185

Sall Fatimata, SC

Role: CONTACT

fatimata.sarr@chu-besancon.fr

Facility Contacts

Marie-France Seronde

Role: primary

Other Identifiers

P/2014/234

Identifier Type: -

Identifier Source: org_study_id