Multidimensional Impact of Telemonitoring in Heart Failure (IMPACT-HF)
- Conditions
- Heart Failure
- Interventions
- Other: Telemonitoring follow-up using medical devices and telematic consultations
- Registration Number
- NCT05653726
- Lead Sponsor
- Hospital Universitario 12 de Octubre
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 390
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Telemonitoring group Telemonitoring follow-up using medical devices and telematic consultations Follow-up group by telematic consultations and non-invasive daily telemonitoring of weight, blood pressure, heart rate, peripheral oxygen saturation and electrocardiogram.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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)
Symptoms 12 months Measured using New York Heart Association dyspnea scale
Number of hospital admissions 12 months For any cause, cardiovascular and for heart failure.
Mortality 12 months For any cause and for cardiovascular cause
Care burden of caregivers 12 months Measured using Zarit scale (values 0 to 88)
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
Trial Locations
- Locations (1)
Hospital Universitario 12 de Octubre
🇪🇸Madrid, Spain