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

Primary Purpose

Heart Failure

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Telemonitoring follow-up using medical devices and telematic consultations
Sponsored by
Hospital Universitario 12 de Octubre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Heart Failure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Telemonitoring group

    Control gropu

    Arm Description

    Follow-up group by telematic consultations and non-invasive daily telemonitoring of weight, blood pressure, heart rate, peripheral oxygen saturation and electrocardiogram.

    Usual care follow-up group

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

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

    Full Information

    First Posted
    November 28, 2022
    Last Updated
    February 28, 2023
    Sponsor
    Hospital Universitario 12 de Octubre
    Collaborators
    Consorcio Centro de Investigación Biomédica en Red (CIBER)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05653726
    Brief Title
    Multidimensional Impact of Telemonitoring in Heart Failure (IMPACT-HF)
    Acronym
    IMPACT-HF
    Official Title
    Impact of Noninvasive Telemonitoring on Clinical Events, Healthcare Resource Use and Costs in Heart Failure
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    April 15, 2023 (Anticipated)
    Primary Completion Date
    December 15, 2023 (Anticipated)
    Study Completion Date
    June 30, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Hospital Universitario 12 de Octubre
    Collaborators
    Consorcio Centro de Investigación Biomédica en Red (CIBER)

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Heart Failure

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    390 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Telemonitoring group
    Arm Type
    Experimental
    Arm Description
    Follow-up group by telematic consultations and non-invasive daily telemonitoring of weight, blood pressure, heart rate, peripheral oxygen saturation and electrocardiogram.
    Arm Title
    Control gropu
    Arm Type
    No Intervention
    Arm Description
    Usual care follow-up group
    Intervention Type
    Other
    Intervention Name(s)
    Telemonitoring follow-up using medical devices and telematic consultations
    Intervention Description
    Home telemonitoring of blood pressure, heart rate and peripheral oxygen saturation on a daily basis during 12 months
    Primary Outcome Measure Information:
    Title
    Health care costs
    Description
    Sum of the costs for the consumption of medicines, primary care consultations, specialist consultations, hospitalization, emergency care and medical transport.
    Time Frame
    12 months
    Secondary Outcome Measure Information:
    Title
    Non-health care costs
    Description
    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)
    Time Frame
    12 months
    Title
    Symptoms
    Description
    Measured using New York Heart Association dyspnea scale
    Time Frame
    12 months
    Title
    Care burden of caregivers
    Description
    Measured using Zarit scale (values 0 to 88)
    Time Frame
    12 months
    Title
    Number of hospital admissions
    Description
    For any cause, cardiovascular and for heart failure.
    Time Frame
    12 months
    Title
    Mortality
    Description
    For any cause and for cardiovascular cause
    Time Frame
    12 months
    Title
    Patient satisfaction with service
    Description
    Measured using a customer satistaction questionnaire (values 0 to 20), with higer scores meaning
    Time Frame
    12 months
    Title
    Adherence to the telemonitoring protocolo
    Description
    Number of transmissions made versus planned at 12 months.
    Time Frame
    12 months
    Title
    Quality of life variation
    Description
    Euroqol-5D-5L questionnaire
    Time Frame
    12 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Juan Carlos López-Azor García, MD, PhD
    Phone
    +34628026462
    Email
    lopez.gcia.juan.carlos@gmail.com

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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

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