Home Electronic Monitoring of Chronic Heart Failure (MEDIC)
Primary Purpose
Chronic Heart Failure
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
telemonitoring of weight, pulse and blood pressure
Sponsored by
About this trial
This is an interventional supportive care trial for Chronic Heart Failure focused on measuring telemonitoring
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
Sites / Locations
- CHU de BesançonRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
telemonitoring
conventional follow-up
Arm Description
telemonitoring of weight, arterial pressure and heart rate at home with connection to a medical platform to monitor the evolution.
conventional follow-up
Outcomes
Primary Outcome Measures
Number of rehospitalizations due to acute heart failure and number of death due to heart failure
Secondary Outcome Measures
Number and cost of consultations, treatments, hospitalization, transport, care of nurses ...
Qualitative interviews of patients and to all medical care services about uses and services rendered by the new device
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
Scores on questionnaires of minnesota, EQ-5D and IADL to evaluate quality of life and autonomy
Mean duration of stay during hospitalization
Number of hospitalization in emergency care unit to measure efficacy of telemonitoring
Number of alarm for increase of weight, hypo- or hypertension, bradycardia or tachycardia as a measure of efficacy of telemonitoring
Full Information
NCT ID
NCT02486887
First Posted
June 1, 2015
Last Updated
July 17, 2018
Sponsor
Centre Hospitalier Universitaire de Besancon
Collaborators
AG2R La Mondiale, IMRI, AFPEC, H2AD, Pôle des Microtechniques de Besançon
1. Study Identification
Unique Protocol Identification Number
NCT02486887
Brief Title
Home Electronic Monitoring of Chronic Heart Failure
Acronym
MEDIC
Official Title
Monitoring Electronique à Distance Des Patients Insuffisants Cardiaques
Study Type
Interventional
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Unknown status
Study Start Date
June 2015 (Actual)
Primary Completion Date
September 2020 (Anticipated)
Study Completion Date
September 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Besancon
Collaborators
AG2R La Mondiale, IMRI, AFPEC, H2AD, Pôle des Microtechniques de Besançon
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
- Data collected
- 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)
- 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)
- 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)
- 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
- 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Heart Failure
Keywords
telemonitoring
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
210 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
telemonitoring
Arm Type
Experimental
Arm Description
telemonitoring of weight, arterial pressure and heart rate at home with connection to a medical platform to monitor the evolution.
Arm Title
conventional follow-up
Arm Type
No Intervention
Arm Description
conventional follow-up
Intervention Type
Device
Intervention Name(s)
telemonitoring of weight, pulse and blood pressure
Primary Outcome Measure Information:
Title
Number of rehospitalizations due to acute heart failure and number of death due to heart failure
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Number and cost of consultations, treatments, hospitalization, transport, care of nurses ...
Time Frame
1 year
Title
Qualitative interviews of patients and to all medical care services about uses and services rendered by the new device
Time Frame
1 year
Title
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
Time Frame
1 year
Title
Scores on questionnaires of minnesota, EQ-5D and IADL to evaluate quality of life and autonomy
Time Frame
1 year
Title
Mean duration of stay during hospitalization
Time Frame
1 year
Title
Number of hospitalization in emergency care unit to measure efficacy of telemonitoring
Time Frame
1 year
Title
Number of alarm for increase of weight, hypo- or hypertension, bradycardia or tachycardia as a measure of efficacy of telemonitoring
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Seronde Marie-France, PH
Phone
0033381668185
Email
mfseronde@chu-besancon.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Sall Fatimata, SC
Email
fatimata.sarr@chu-besancon.fr
Facility Information:
Facility Name
CHU de Besançon
City
Besançon
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marie-France Seronde
12. IPD Sharing Statement
Learn more about this trial
Home Electronic Monitoring of Chronic Heart Failure
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