Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Heart Failure Events Reduction With Remote Monitoring and eHealth Support Investigator Initiated Trial (HERMeS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03663907
Recruitment Status : Recruiting
First Posted : September 10, 2018
Last Update Posted : July 17, 2019
Sponsor:
Collaborator:
Institut d'Investigació Biomèdica de Bellvitge
Information provided by (Responsible Party):
Josep Comín, Hospital Universitari de Bellvitge

Brief Summary:
The primary objective of the study is to evaluate the efficacy of a telemedicine-based follow-up strategy compared with usual care in the management of patients with chronic heart failure (HF) at high risk of clinical events.

Condition or disease Intervention/treatment Phase
Heart Failure Procedure: Telemonitoring Not Applicable

Detailed Description:

The HERMeS Trial (Heart failure Events reduction with Remote Monitoring and eHealth Support) is a multicenter, prospective, randomized, open label, observational investigator initiated study to assess the effect on cardiovascular mortality and non-fatal heart failure (HF) events of a telemedicine-based comprehensive management program for patients with chronic HF by means of remote daily telemonitoring of signs and symptoms of HF and remote structured follow-up using videoconference. The organizational characteristics of the programme and the impact in health outcomes resulting from its implementation have been previously published.

In this study we aim to compare the strategy of providing nurse-based structured follow-up to high-risk chronic HF patients through planned contacts between health care providers and patients and/or caregivers in the basis of face-to-face on-site encounters (usual care) or provide the planned care using telemedicine with the combination of remote daily monitoring of signs and symptoms of HF (telemonitoring) and delivery of structured nurse-based follow-up health care using videoconference (tele-intervention).

The main hypothesis of the study is that daily telemonitoring of clinical variables and symptoms in high-risk patients with HF allows early detection of decompensations by decreasing the number of fatal cardiovascular events or non-fatal HF events. As a secondary hypothesis we assume that tele-intervention using telemedicine may help to optimise neurohormonal treatment and deliver appropriate education to high-risk patients with HF; and delivery of care in high risk patients with HF through the combination of remote monitoring and tele-intervention may translate into a reduction of fatal and non fatal HF-related events.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 508 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Heart Failure Events Reduction With Remote Monitoring and eHealth Support Investigator Initiated Trial
Actual Study Start Date : May 15, 2018
Estimated Primary Completion Date : June 1, 2020
Estimated Study Completion Date : July 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
Experimental: Telemonitoring
Structured follow-up in the basis of using telemedicine. Telemedicine will include daily signs and symptoms telemonitoring and structured follow-up by the means of video or audio-conference.
Procedure: Telemonitoring

The system (the home tele-healthcare platform) designed jointly by engineers and clinical personal to be able daily automated selfreported symptom and weight, blood pressure and heart rate monitoring. The system allow weekly follow up through videoconferences.

Information from the telemonitoring system is automatically downloaded to a secure Internet site for review by clinicians and nurses daily.


No Intervention: Usual Care
Patients with usual care follow-up in a heart failure program.



Primary Outcome Measures :
  1. Occurrence of cardiovascular death or non-fatal heart failure events. [ Time Frame: Six months after inclusion of the patient ]
    Occurrence of cardiovascular death or non-fatal heart failure events (time to first event) during a follow-up period of 6 months. Non-fatal heart failure event is defined as a new episode of worsening of symptoms and signs consistent with acute decompensated HF requiring intravenous decongestive therapy (e.g. diuretics) either on an outpatient basis (day-case HF hospital) or in the emergency department (<24 hours) or requiring unplanned hospital admission (>24 hours) or complicating the course of a non-cardiovascular admission.


Secondary Outcome Measures :
  1. Readmission (all-cause, HF and cardiovascular) rate and total number. [ Time Frame: Six months after inclusion of the patient. ]
    Comparison of both strategies at the end of follow-up.

  2. Days in hospital (all-cause, HF and cardiovascular). [ Time Frame: Six months after inclusion of the patient. ]
    Comparison of both strategies at the end of follow-up.

  3. Rate of emergency visits. [ Time Frame: Six months after inclusion of the patient. ]
    Comparison of both strategies at the end of follow-up.

  4. Rate of non-fatal HF events. [ Time Frame: Six months after inclusion of the patient. ]
    Comparison of both strategies at the end of follow-up.

  5. Mortality for any cause and cardiovascular mortality. [ Time Frame: Six months after inclusion of the patient. ]
    Comparison of both strategies at the end of follow-up.

  6. Improvement of self-care using a validated scale (European Heart Failure Self-Care Behavior Scale). [ Time Frame: Six months after inclusion of the patient. ]
    Comparison of both strategies at the end of follow-up.

  7. Improvement of quality of life using a validated questionnaire (EUROQOL - 5D). [ Time Frame: Six months after inclusion of the patient. ]
    Comparison of both strategies at the end of follow-up.

  8. Patient satisfaction using a Likert-type scale. [ Time Frame: Six months after inclusion of the patient. ]
    Comparison of both strategies at the end of follow-up.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age ≥ 18 years old.
  • Patients discharged from a heart failure hospitalization within 30 days of enrollment into the study or in the process of discharge planning.
  • Heart Failure diagnosis according to European Society of Cardiology (ESC) criteria.
  • Written informed consent must be obtained before any assessment is performed.
  • Patients receiving oral standard medication for chronic heart failure (CHF).
  • All patients will be eligible regardless the level of left ventricular ejection fraction (LVEF).

Exclusion Criteria:

  • Age<18 years old.
  • Participation in another clinical trial.
  • Moderate or severe cognitive impairment without a competent caregiver.
  • Lack of social support.
  • Institutionalized patients.
  • Life expectancy less than 1 year (excluding HF).
  • Candidates for home-based or institutional end-of-life care.
  • Serious psychiatric illness.
  • Planned cardiac surgery.
  • Planned Heart transplantation or left ventricular assist device (LVAD) implant.
  • Patients in hemodialysis program.
  • Death before hospital discharge.
  • The patient is unable or unwilling to give the informed consent to participate.
  • The patient is considered not to be an adequate candidate for this study according to the decision of the local investigator.
  • Unstable patients with signs of fluid overload or low cardiac output.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03663907


Contacts
Layout table for location contacts
Contact: Josep Comín Colet, MD,PhD +34 93 260 7078 jcomin@bellvitgehospital.cat
Contact: Sergi Yun Viladomat, MD +34 93 260 7078 sergi.yun@bellvitgehospital.cat

Locations
Layout table for location information
Spain
University Hospital Bellvitge Recruiting
L'Hospitalet de Llobregat, Barcelona, Spain, 08907
Contact: Josep Comín Colet, MD, PhD         
Sponsors and Collaborators
Hospital Universitari de Bellvitge
Institut d'Investigació Biomèdica de Bellvitge
Investigators
Layout table for investigator information
Principal Investigator: Josep Comín Colet, MD,PhD Hospital Universitari de Bellvitge
Layout table for additonal information
Responsible Party: Josep Comín, Head of the Community Heart Failure Unit, Cardiology Department. MD, PhD, Hospital Universitari de Bellvitge
ClinicalTrials.gov Identifier: NCT03663907    
Other Study ID Numbers: IDIBELL- 2017/PR190/17
First Posted: September 10, 2018    Key Record Dates
Last Update Posted: July 17, 2019
Last Verified: July 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Josep Comín, Hospital Universitari de Bellvitge:
Telemedicine
Telemonitoring
Disease Management
Chronic Care Model
Transitional Care
Additional relevant MeSH terms:
Layout table for MeSH terms
Heart Failure
Heart Diseases
Cardiovascular Diseases