'heart failure'
Conditions
Interventions
Group 1: an extended multimodality remote monitoring intervention including
telemonitoring with the Luscii heart failure app, nurse home visits by Cordaan
heart failure home care and a network care
Sponsors
OLVG
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Age > 18 years - Written informed consent - Permission for data sharing through Luscii heart failure application and/or Virtual Ward and cBoards telemonitoring programme - Availability of a proper computer device (including smartphones) for the use of Luscii heart failure application - Diagnosis of new onset or chronic heart failure, independent of LVEF, with an episode of WHF requiring intravenous treatment with diuretics* in the past 7 days before randomization *WHF for inclusion defined as: HF hospitalization, urgent HF visit resulting in iv diuretic treatment or outpatient treatment with iv diuretics.
Exclusion criteria
Exclusion criteria: - New onset heart failure in case of primary reason of admission being supraventricular tachycardia accompanied by mild decompensation without need for continuation of diuretics at time of hospital discharge - Glomerular Filtration Rate (GFR)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is a composite of time to all-cause mortality or first WHF event, comparing the intervention on top of standard HF care with standard HF care alone at 180 days of follow-up. The co-primary endpoint is the total number of (recurrent) WHF events at 180 days of follow-up. The definition of a WHF event is a HF hospitalization (unscheduled admission > 6 hours), urgent HF visit resulting in iv diuretic treatment, outpatient treatment with iv diuretics or outpatient intensification of oral diuretics. | — |
Secondary
| Measure | Time frame |
|---|---|
| The main secondary endpoints are the total number of the individual components of WHF events (HFH, UHF, outpatient treatment with iv diuretics and outpatient intensification of oral diuretics) at 30 and 180 days follow-up and time to (all-cause and cardiovascular) mortality and first WHF event at 180 days follow-up. Also, the effect of the RM strategy on total number of all cause hospitalizations at 30 and 180 days follow-up will be analysed. Finally, change in quality of life assessed with the KCCQ questionnaire between baseline (T0) and 180 days follow-up is analysed. Exploratory endpoints include health care consumption, cost-effectiveness, medication adherence and patient and caregiver satisfaction. | — |
Countries
Netherlands
Contacts
Public ContactL. Heerebeek
OLVG
Outcome results
None listed