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| Name | Class |
|---|---|
| AG2R La Mondiale | OTHER |
| IMRI | UNKNOWN |
| AFPEC | UNKNOWN |
| H2AD |
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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 :
prospective, monocentric, randomized open-labeled study.
- Data collected
- 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 :
- 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| telemonitoring | Experimental | telemonitoring of weight, arterial pressure and heart rate at home with connection to a medical platform to monitor the evolution. |
|
| conventional follow-up | No Intervention | conventional follow-up |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| telemonitoring of weight, pulse and blood pressure | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of rehospitalizations due to acute heart failure and number of death due to heart failure | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Number and cost of consultations, treatments, hospitalization, transport, care of nurses ... | 1 year | |
| Qualitative interviews of patients and to all medical care services about uses and services rendered by the new device | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Seronde Marie-France, PH | Contact | 0033381668185 | mfseronde@chu-besancon.fr | |
| Sall Fatimata, SC | Contact | fatimata.sarr@chu-besancon.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Besançon | Recruiting | Besançon | France |
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| ID | Term |
|---|---|
| D006339 | Heart Rate |
| D001794 | Blood Pressure |
| ID | Term |
|---|---|
| D055986 | Vital Signs |
| D010808 | Physical Examination |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| Pôle des Microtechniques de Besançon | UNKNOWN |
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| 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 |
| Scores on questionnaires of minnesota, EQ-5D and IADL to evaluate quality of life and autonomy | 1 year |
| Mean duration of stay during hospitalization | 1 year |
| Number of hospitalization in emergency care unit to measure efficacy of telemonitoring | 1 year |
| Number of alarm for increase of weight, hypo- or hypertension, bradycardia or tachycardia as a measure of efficacy of telemonitoring | 1 year |
| D006439 |
| Hemodynamics |
| D002320 | Cardiovascular Physiological Phenomena |
| D002943 | Circulatory and Respiratory Physiological Phenomena |