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

Heart Failure Clinical Trial

— IMPACT-HF  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05653726
• Other study ID #: HU12Octubre
• Status: Recruiting
• Phase: N/A
• Start date: November 29, 2023
• Est. completion date: June 30, 2025

Study information

• Verified date: February 2024
• Source: Hospital Universitario 12 de Octubre
• Contact: Juan Carlos López-Azor García, MD, PhD
• Phone: +34628026462
• Email: lopez.gcia.juan.carlos[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 390
• Est. completion date: June 30, 2025
• Est. primary completion date: June 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Heart Failure

Intervention

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

Locations

Country	Name	City	State
Spain	Hospital Universitario 12 de Octubre	Madrid

Sponsors (2)

Lead Sponsor	Collaborator
Hospital Universitario 12 de Octubre	Consorcio Centro de Investigación Biomédica en Red (CIBER)

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Symptoms	Measured using New York Heart Association dyspnea scale	12 months
Secondary	Care burden of caregivers	Measured using Zarit scale (values 0 to 88)	12 months
Secondary	Number of hospital admissions	For any cause, cardiovascular and for heart failure.	12 months
Secondary	Mortality	For any cause and for cardiovascular cause	12 months
Secondary	Patient satisfaction with service	Measured using a customer satistaction questionnaire (values 0 to 20), with higer scores meaning	12 months
Secondary	Adherence to the telemonitoring protocolo	Number of transmissions made versus planned at 12 months.	12 months
Secondary	Quality of life variation	Euroqol-5D-5L questionnaire	12 months