Heart Failure
Conditions
Brief summary
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: * Does telematic follow-up reduce de use of healthcare resource utilization of patients with heart failure? * Is telematic follow-up cost-efficient in terms of reducing direct healthcare costs in heart failure patients? * Is telematic follow-up cost-efficient in terms of reducing non-healthcare costs in heart failure patients? Participants will be randomized to usual care (control group) or telematic care (interventional group). Patients randomized to the interventional group will be included in a protocol of daily automatic telemonitoring of arterial pressure, peripheral oximetry, heart rate and weight, and telematic consultations lead by a heart failure clinical specialized team. Researchers will compare the healthcare resource utilization, healthcare and non-healthcare costs of patients randomized to control vs. interventional group.
Interventions
OTHERTelemonitoring follow-up using medical devices and telematic consultations
Home telemonitoring of blood pressure, heart rate and peripheral oxygen saturation on a daily basis during 12 months
Sponsors
Consorcio Centro de Investigación Biomédica en Red (CIBER)
Fundacion Investigacion Biomedica Hospital 12 de Octubre
Hospital Universitario Puerta de Hierro de Majadahonda
Hospital Universitario 12 de Octubre
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosis of HF according to the 2021 guidelines of the European Society of Cardiology criteria for ≥3 months. * Admitted for decompensation of chronic HF. * Admitted for HF decompensation ≥30 days and ≤6 months. * HF decompensation in ≥30 days and ≤6 months but discharged directly from the emergency department or managed on an outpatient basis, but requiring intravenous diuretic administration in an ambulatory basis, or \>50% increase in loop diuretic dose. * With previous optimized prognostic medical treatment. * Under treatment with loop diuretic drugs. * New York Heart Association functional class II, III or IV.
Exclusion criteria
* Inclusion in other intervention studies. * Hemodynamic instability. * Acute myocardial infarction, acute pulmonary thromboembolism or stroke in the previous 40 days. * Uncontrolled arrhythmias * On waiting list for transplantation (any organ) or other cardiac surgery. * Advanced mechanical circulatory support. * Chronic renal disease on hemodialysis. * Life expectancy less than 1 year. * Moderate-severe cognitive impairment. * Manifest inability to use a technological system. * Institutionalized. * Limiting psychiatric pathology.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Health care costs | 12 months | Sum of the costs for the consumption of medicines, primary care consultations, specialist consultations, hospitalization, emergency care and medical transport. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Symptoms | 12 months | Measured using New York Heart Association dyspnea scale |
| Care burden of caregivers | 12 months | Measured using Zarit scale (values 0 to 88) |
| Number of hospital admissions | 12 months | For any cause, cardiovascular and for heart failure. |
| Non-health care costs | 12 months | 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) |
| Patient satisfaction with service | 12 months | Measured using a customer satistaction questionnaire (values 0 to 20), with higer scores meaning |
| Adherence to the telemonitoring protocolo | 12 months | Number of transmissions made versus planned at 12 months. |
| Quality of life variation | 12 months | Euroqol-5D-5L questionnaire |
| Mortality | 12 months | For any cause and for cardiovascular cause |
Countries
Spain
Contacts
Primary ContactJuan Carlos López-Azor García, MD, PhD
Outcome results
None listed