Evalutation of a Hybrid Care Pathway With Remote MONitoring for Heart Failure

Обзор

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.

Подробное описание

The HARMONY-HF study is a real-world, multicentre, observational cohort study with both retrospective and prospective components.

Вмешательства

• Другое 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

Первичные конечные точки

• Number of days spent out of hospital within one year [Срок оценки: From enrollment to the end of follow-up at 400 days after inclusion]

Вторичные конечные точки (5)

• All-cause survival [Срок оценки: From enrollment to the end of follow-up at 400 days after inclusion]
• HF-related survival [Срок оценки: From enrollment to the end of follow-up at 400 days after inclusion]
• Health-related quality of life (KCCQ-12) [Срок оценки: Baseline, 3 months, 6 months and 12 months]
• Healthcare utalisation and associated costs [Срок оценки: From enrollment to the end of follow-up at 400 days after inclusion]
• Guideline-Directed Medical Treatment (GMDT) scores [Срок оценки: Baseline, 6 weeks, 3 months, 6 months and 12 months]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• Inability or unwillingness to participate in home telemonitoring
• Patients with end-stage heart failure or other terminal conditions

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Нидерланды · 7 центров

• OLVG — Amsterdam
• Catharina Hospital — Eindhoven
• Medisch Spectrum Twente — Enschede
• Martini Hospital — Groningen
• St. Antonius Hospital — Nieuwegein
• Canisius-Wilhelmina Hospital — Nijmegen
• Maasstad Hospital — Rotterdam

Идентификаторы

NCT: NCT07680634 · SDB 2025-019

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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