Evalutation of a Hybrid Care Pathway With Remote MONitoring for Heart Failure
ConditionHeart Failure
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorSt. Antonius Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Inability or unwillingness to participate in home telemonitoring
Patients with end-stage heart failure or other terminal conditions
Trial population
The entire HF population treated at the participating hospitals will be included in the analysis, except for those patients who have formally objected to the use of their data for scientific research
Trial design
Design model
Cohort
Time perspective
Other
Treatments tested in this trial
Hybrid heart failure care pathway
Other interventionThe 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 Dutch-speaking, either themselves or through an informal caregiver.
Treatment groups
6,000 Participants
are divided into 1 treatment groupGroup A: Conventional heart failure care pathway1 intervention
Trial outcomes
Primary outcomes
1
Number of days spent out of hospital within one year
For each patient, follow-up time is calculated from the inclusion date until the earliest of the following: the end of the 400-day analysis period, death, or the last known date of contact (i.e., loss to follow-up). The number of days without hospitalisation is derived by subtracting the number of unplanned in-hospital days from each patient's accumulated person-time. By censoring follow-up at the date of death, person-time reflects only the period during which a patient was actually observed and at risk, thereby accounting for the competing risk of mortality. Although the primary outcome concerns the first year of follow-up, the analysis period is defined as the first 400 days after the inclusion date rather than exactly 365 days. In routine clinical practice, it is not always possible for a patient to attend an outpatient contact precisely 365 days after the start date. A modest margin is incorporated around the one-year mark, thereby maximising the proportion of complete follow-up.
Time frame
From enrollment to the end of follow-up at 400 days after inclusionSecondary outcomes
1
All-cause survival
Probability of survival free from all-cause death, estimated using the Kaplan-Meier method, reported as the percentage of participants alive at 400 days.
Time frame
From enrollment to the end of follow-up at 400 days after inclusion2
HF-related survival
Probability of heart failure related death, estimated using the Kaplan-Meier method, reported as the percentage of participants alive at 400 days.
Time frame
From enrollment to the end of follow-up at 400 days after inclusion3
Health-related quality of life (KCCQ-12)
Based on the Kansas City Cardiomyopathy Questionnaire, units on a scale 0-100 (higher is better)
Time frame
Baseline, 3 months, 6 months and 12 months4
Healthcare utalisation and associated costs
An economic evaluation will be performed as a cost-effectiveness analysis from a healthcare payer perspective and will be based on a discrete event simulation (DES) model. This event- and time-based structure is particularly suited for HF, in which the risk of clinical worsening/decompensation fluctuates over time and is influenced by patient-specific characteristics, and it allows for heterogeneity of the real-world population captured in this study. Patient-level data from both cohorts will be used to inform the model's input parameters. Costs will comprise those of regular HF care, home telemonitoring, clinical events and outpatient contacts, and pharmaceutical treatment, valued using the Dutch costing manual in accordance with the guidelines for economic evaluations. The primary economic outcome will be the incremental cost-effectiveness ratio (ICER).
Time frame
From enrollment to the end of follow-up at 400 days after inclusionSponsors and contacts
Click on the lead sponsor to view all of their trials.
St. Antonius Hospital
Lead sponsor
ZonMw: The Netherlands Organisation for Health Research and Development
Collaborator
Source ClinicalTrials.gov