Evalutation of a Hybrid Care Pathway With Remote MONitoring for Heart Failure
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Hybrid heart failure care pathway.
- Who it may be relevant to
- Registry conditions: Heart Failure. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Netherlands
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
Heart failure is a long-term condition in which the heart cannot pump blood as well as it should. People with heart failure often need to be admitted to hospital when their symptoms suddenly get worse, which affects their quality of life and places a heavy burden on the healthcare system. In recent years, hospitals have started using home telemonitoring, in which patients measure values such as their weight, blood pressure, heart rate, and symptoms at home every day. These measurements are sent to a Medical Service Center (MSC), who can step in quickly when early warning signs appear - often before the patient feels seriously unwell. The HARMONY-HF study looks at how well this hybrid care pathway works in everyday practice. The researchers will compare heart failure patients who take part in the home telemonitoring programme with patients who receive usual care without telemonitoring, across seven hospitals in the Netherlands. Because all care is part of routine treatment, patients are not asked to do anything extra for the study; the researchers use information that is already collected during normal care. The main goal is to find out whether patients in the telemonitoring programme spend more days at home and out of the hospital. The study also looks at survival, hospital admissions, quality of life, and the use of recommended heart failure medication. The findings will help determine whether this approach should be offered more widely.
Detailed description
The HARMONY-HF study is a real-world, multicentre, observational cohort study with both retrospective and prospective components.
Interventions
- Other Hybrid heart failure care pathway
The intervention cohort comprises all adult patients (aged 18 years or older) with an established diagnosis of HF, made in accordance with the prevailing European Society of Cardiology guidelines and irrespective of HF phenotype, who are enrolled in the hybrid care pathway with home telemonitoring since the start of implementation of the program in May 2023. Patients are included in the hybrid care pathwat if they are treated at the outpatient clinic, and are sufficiently digitally literate and
Primary outcome measures
- Number of days spent out of hospital within one year [Time frame: From enrollment to the end of follow-up at 400 days after inclusion]
Secondary outcome measures (5)
- All-cause survival [Time frame: From enrollment to the end of follow-up at 400 days after inclusion]
- HF-related survival [Time frame: From enrollment to the end of follow-up at 400 days after inclusion]
- Health-related quality of life (KCCQ-12) [Time frame: Baseline, 3 months, 6 months and 12 months]
- Healthcare utalisation and associated costs [Time frame: From enrollment to the end of follow-up at 400 days after inclusion]
- Guideline-Directed Medical Treatment (GMDT) scores [Time frame: Baseline, 6 weeks, 3 months, 6 months and 12 months]
Eligibility criteria
Inclusion criteria
- Adults (at least 18 years or older)
- Diagnosed with heart failure according the prevailling ESC guideline
- Treatment at the outpatient clinic at one of the seven participating hospitals
- Sufficient digital literacy and adequate Dutch language proficiency by the patient or throught the informal caregiver.
Exclusion criteria
- Inability or unwillingness to participate in home telemonitoring
- Patients with end-stage heart failure or other terminal conditions
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Netherlands · 7 centers
- OLVG — Amsterdam
- Catharina Hospital — Eindhoven
- Medisch Spectrum Twente — Enschede
- Martini Hospital — Groningen
- St. Antonius Hospital — Nieuwegein
- Canisius-Wilhelmina Hospital — Nijmegen
- Maasstad Hospital — Rotterdam
Identifiers
NCT: NCT07680634 · SDB 2025-019