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

Hospital Universitario 12 de Octubre1 site in 1 country390 target enrollmentNovember 29, 2023

ConditionsHeart Failure

Overview

Phase: N/A
Intervention: Not specified
Conditions: Heart Failure
Sponsor: Hospital Universitario 12 de Octubre
Enrollment: 390
Locations: 1
Primary Endpoint: Health care costs
Status: Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

November 29, 2023

End Date

December 31, 2025

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Hospital Universitario 12 de Octubre

Responsible Party

Principal Investigator

Juan Carlos López-Azor

Principal Investigator, Doctor in Medicine

Hospital Universitario 12 de Octubre

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Health care costs

Time Frame: 12 months

Sum of the costs for the consumption of medicines, primary care consultations, specialist consultations, hospitalization, emergency care and medical transport.