Multidimensional Impact of Telemonitoring in Heart Failure (IMPACT-HF)

Study Overview
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Brief Summary
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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: 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.

Official Title
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Impact of Noninvasive Telemonitoring on Clinical Events, Healthcare Resource Use and Costs in Heart Failure

Conditions
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Heart Failure

Intervention / Treatment
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* Other: Telemonitoring follow-up using medical devices and telematic consultations


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Telemonitoring group<br>Follow-up group by telematic consultations and non-invasive daily telemonitoring of weight, blood pressure, heart rate, peripheral oxygen saturation and electrocardiogram. | Other: Telemonitoring follow-up using medical devices and telematic consultations<br>* Home telemonitoring of blood pressure, heart rate and peripheral oxygen saturation on a daily basis during 12 months<br>|
| No Intervention: Control gropu<br>Usual care follow-up group | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |