Clinical trial NCT05653726: Multidimensional Impact of Telemonitoring in Heart Failure (IMPACT-HF)
Official title: Impact of Noninvasive Telemonitoring on Clinical Events, Healthcare Resource Use and Costs in Heart Failure
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Heart Failure
Lead sponsor: Hospital Universitario 12 de Octubre
Sponsor class: OTHER
Collaborators: name: Consorcio Centro de Investigación Biomédica en Red (CIBER)
name: Fundacion Investigacion Biomedica Hospital 12 de Octubre
name: Hospital Universitario Puerta de Hierro de Majadahonda
First posted: 2022-12-16
Enrollment: 390
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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.
* Institutionalized.
* Limiting psychiatric pathology.

Primary outcomes:
measure: Health care costs
timeFrame: 12 months
Secondary outcomes:
measure: Non-health care costs
timeFrame: 12 months
measure: Symptoms
timeFrame: 12 months
measure: Care burden of caregivers
timeFrame: 12 months
measure: Number of hospital admissions
timeFrame: 12 months
measure: Mortality
timeFrame: 12 months
measure: Patient satisfaction with service
timeFrame: 12 months
measure: Adherence to the telemonitoring protocolo
timeFrame: 12 months
measure: Quality of life variation
timeFrame: 12 months
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
Study officials:
References: