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| Name | Class |
|---|---|
| Consorcio Centro de Investigación Biomédica en Red (CIBER) | OTHER_GOV |
| Fundacion Investigacion Biomedica Hospital 12 de Octubre | UNKNOWN |
| Puerta de Hierro University Hospital | OTHER |
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The goal of this clinical trial is to know if telemonitoring and telematic follow-up reduces the healthcare resources utilization, healthcare costs and non-healthcare costs of patients with high-risk heart failure. The main questions it aims to answer are:
Researchers will compare the healthcare resource utilization, healthcare and non-healthcare costs of patients randomized to control vs. interventional group.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Telemonitoring group | Experimental | Follow-up group by telematic consultations and non-invasive daily telemonitoring of weight, blood pressure, heart rate, peripheral oxygen saturation and electrocardiogram. |
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| Control gropu | No Intervention | Usual care follow-up group |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Telemonitoring follow-up using medical devices and telematic consultations | Other | Home telemonitoring of blood pressure, heart rate and peripheral oxygen saturation on a daily basis during 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Health care costs | Sum of the costs for the consumption of medicines, primary care consultations, specialist consultations, hospitalization, emergency care and medical transport. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Non-health care costs | Sum of informal costs (care provided by people who are not health or social care professionals) and professional costs (home help, tele-health, tele-assistance, ambulatory care centers and use of nursing homes) | 12 months |
| Symptoms |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Juan Carlos López-Azor García, MD, PhD | Contact | +34628026462 | lopez.gcia.juan.carlos@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario 12 de Octubre | Recruiting | Madrid | Madrid | Spain |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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Measured using New York Heart Association dyspnea scale |
| 12 months |
| Care burden of caregivers | Measured using Zarit scale (values 0 to 88) | 12 months |
| Number of hospital admissions | For any cause, cardiovascular and for heart failure. | 12 months |
| Mortality | For any cause and for cardiovascular cause | 12 months |
| Patient satisfaction with service | Measured using a customer satistaction questionnaire (values 0 to 20), with higer scores meaning | 12 months |
| Adherence to the telemonitoring protocolo | Number of transmissions made versus planned at 12 months. | 12 months |
| Quality of life variation | Euroqol-5D-5L questionnaire | 12 months |