Evalutation of a Hybrid Care Pathway With Remote MONitoring for Heart Failure
Recruiting · NCT07680634 · Observational (researchers observe without assigning treatment) · Lead sponsor: St. Antonius Hospital
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
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
Where it is running
7 locations listed.
- OLVG - Amsterdam, Utrecht, Netherlands
- Catharina Hospital - Eindhoven, Utrecht, Netherlands
- Medisch Spectrum Twente - Enschede, Utrecht, Netherlands
- Martini Hospital - Groningen, Utrecht, Netherlands
- St. Antonius Hospital - Nieuwegein, Utrecht, Netherlands
- Canisius-Wilhelmina Hospital - Nijmegen, Utrecht, Netherlands
- Maasstad Hospital - Rotterdam, Utrecht, Netherlands