The classic website will no longer be available as of June 25, 2024. Please use the modernized ClinicalTrials.gov.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    RELEASE-HF
Previous Study | Return to List | Next Study

REsponsible roLl-out of E-heAlth Through Systematic Evaluation - Heart Failure Study (RELEASE-HF)

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: NCT05654961
Recruitment Status : Recruiting
First Posted : December 16, 2022
Last Update Posted : December 16, 2022
Sponsor:
Information provided by (Responsible Party):
Prof. Dr. F.W. Asselbergs, UMC Utrecht

Brief Summary:

Telemedicine is gradually becoming accepted in heart failure (HF) management. Meta-analyses show a positive effect of telemedicine on hospital admission, length of stay, mortality, and costs. However, the magnitude of the effect is heterogeneous because of the variety in the HF population using telemedicine, components of telemedicine, and variety in considered costs. Despite the lack of clear guidance how to implement telemedicine within routine HF management, implementation of telemedicine is advocated by payers, private companies, and patient organizations.

In this nationwide study the investigators aim to identify in which subgroup of HF patients telemedicine is (cost-)effective, and which intervention components of telemedicine are most (cost-)effective.


Condition or disease Intervention/treatment
Heart Failure Other: Use of telemedicine

Detailed Description:

The objectives of the study are to examine:

  1. which HF patient characteristics are related to an increase in number of days spent outside the hospital within one year of follow-up, when telemedicine is part of regular HF care compared to regular HF care alone?
  2. which HF patient characteristics are related to cost-effectiveness when telemedicine is part of regular care compared to regular HF care alone?
  3. which components of telemedicine as part of regular HF care lead to an increase in number of days spent outside the hospital within one year of follow-up?
  4. which components of telemedicine as part of regular HF care are cost-effective?

The main focus of this study is on patient-related subgroup analyses with telemedicine. The patient-related subgroups are identified by a systematic literature review of randomized-controlled trials of telemedicine: (1) age, (2) severity of HF (NYHA class at baseline), (3) sex (female compared to male), (4) socio-economic status (SES) (HF patients with higher SES compared to lower SES), (5) presence of depression, (6) Type of heart failure (LVEF: HFrEF, HFmrEF, HFpEF), (7) presence of atrial fibrillation (AF). In an additional analysis, (8) heterogeneity across time of diagnosis will be explored (recently diagnosed compared to not recently diagnosed).

To answer the four research questions a RELEASE-HF database will be set up. The RELEASE-HF database will be composed from various data sources:

  1. National Heart Failure Registry (abbreviated as Registry; a patient registry),
  2. Interviews with clinicians about telemedicine features on hospital level,
  3. Interviews with finance department staff about costs in HF care (including telemedicine use),
  4. Electronic Health Record (EHR) data about telemedicine (including supplier system data)
  5. External national registries and/or databases as Statistics Netherlands (CBS), declaration data (Vektis), Dutch Hospital Data (DHD) or PHARMO.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 6480 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: REsponsible roLl-out of E-heAlth Through Systematic Evaluation - Heart Failure Study
Actual Study Start Date : January 1, 2022
Estimated Primary Completion Date : December 31, 2024
Estimated Study Completion Date : December 31, 2024

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Heart failure patients
According to the eligibility criteria specified below.
Other: Use of telemedicine
Use of telemedicine (any type: telephone only, non-invasive, implantable-cardioverter-defibrillator-based, invasive) in heart failure management




Primary Outcome Measures :
  1. Number of days spent outside the hospital within one year of follow-up [ Time Frame: 12 months ]
    The number of days will be derived from the number of hospital days and mortality status between follow-up moments.


Secondary Outcome Measures :
  1. All-cause mortality [ Time Frame: 12 months ]
    Mortality status, determined after verification at the Personal Records Database (in Dutch: Basisregistratie Personen).

  2. Change from baseline in functional status at 12 months [ Time Frame: Baseline, 12 months ]

    New York Heart Association classification class (NYHA): a functional classification of patients, based on severity of symptoms and physical activity, with specific attention to fatigue, palpitation, and dyspnea. NYHA exist of four classifacation. A higher class means a patient has more physcial problems caused by heart failure.

    Class I: No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, dyspnea (shortness of breath).

    Class II: Slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea (shortness of breath).

    Class III: Marked limitation of physical activity. Comfortable at rest. Less than ordinary activity causes fatigue, palpitation, or dyspnea.

    Class IV: Unable to carry on any physical activity without discomfort. Symptoms of heart failure at rest. If any physical activity is undertaken, discomfort increases.


  3. Change from baseline in health status at 12 months [ Time Frame: Baseline, 12 months ]
    SF-36 or SF-12 questionnaire (subset of SF-36): a validated patient-reported survey of patient health. Both questionnaires consist of eight sections with scores: vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, and mental health. Each score is transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the lower the health status.

  4. Change from baseline in QoL (Quality of Life) at 12 months [ Time Frame: Baseline, 12 months ]
    SF-36 or SF-12 questionnaire. Quality Adjusted Life Years (QALY) will be calculated based on the SF-6D: a model in which directly a single, preference-based score can be calculated for the SF-36 and SF-12. Scores range from 0.0 (worst health state) to 1.0 (best health state).

  5. Outpatient visits [ Time Frame: 12 months ]
    Number of outpatient visits (planned/unplanned).

  6. Costs [ Time Frame: 12 months ]
    Costs estimated from patient, disease, and treatment characteristics. Information taken into account includes medication use, whether the patient underwent cardiac interventions (e.g., pacemaker implantation, percutaneous coronary intervention), use of telemedicine, hospital admission days, visits to the outpatient clinic, visits to the emergency room, admission days at an intensive care unit, visits at the GP related to HF



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:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients diagnosed with heart failure and who are treated at an outpatient clinic in the Netherlands, with or without telemedicine use.
Criteria

Inclusion Criteria:

  • All heart failure patients newly admitted to a hospital outpatient clinic for HF
  • All phenotypes of heart failure that meet the ESC 2021 guideline
  • Patient who has been diagnosed with heart failure in a setting other than the one where the patient currently presents (primary, secondary or tertiary care)

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): NCT05654961


Contacts
Layout table for location contacts
Contact: Jorna van Eijk, MSc +31634609890 j.vaneijk-4@umcutrecht.nl

Locations
Show Show 34 study locations
Sponsors and Collaborators
UMC Utrecht
Investigators
Layout table for investigator information
Principal Investigator: Folkert W. Asselbergs, MD, PhD UMC Utrecht
Additional Information:
Layout table for additonal information
Responsible Party: Prof. Dr. F.W. Asselbergs, MD, PhD, UMC Utrecht
ClinicalTrials.gov Identifier: NCT05654961    
Other Study ID Numbers: 21-634/C
First Posted: December 16, 2022    Key Record Dates
Last Update Posted: December 16, 2022
Last Verified: December 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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 Prof. Dr. F.W. Asselbergs, UMC Utrecht:
Telemedicine
Observational study
Registry
Multicenter
Additional relevant MeSH terms:
Layout table for MeSH terms
Heart Failure
Heart Diseases
Cardiovascular Diseases