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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Heart Failure
• Intervention / Treatment: Other: Telemonitoring follow-up using medical devices and telematic consultations

• Study Type: Interventional
• Enrollment (Estimated): 390
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Juan Carlos López-Azor García, MD, PhD; Phone Number: +34628026462; Email: lopez.gcia.juan.carlos@gmail.com

Study Locations

• Spain
  • Madrid, Spain
    • Recruiting
    • Hospital Universitario 12 de Octubre
    • Contact: Juan Carlos López-Azor, PhD; Phone Number: +34628026462; Email: lopez.gcia.juan.carlos@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Telemonitoring group; 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; Home telemonitoring of blood pressure, heart rate and peripheral oxygen saturation on a daily basis during 12 months
No Intervention: Control gropu; Usual care follow-up group

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Hospital Universitario 12 de Octubre
• Collaborators: Consorcio Centro de Investigación Biomédica en Red (CIBER)

Study record dates

Study Major Dates

• Study Start (Actual): November 29, 2023
• Primary Completion (Estimated): June 15, 2024
• Study Completion (Estimated): June 30, 2025

Study Registration Dates

• First Submitted: November 28, 2022
• First Submitted That Met QC Criteria: December 7, 2022
• First Posted (Actual): December 16, 2022

Study Record Updates

• Last Update Posted (Estimated): February 21, 2024
• Last Update Submitted That Met QC Criteria: February 19, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: HU12Octubre

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No