The primary objective is to demonstrate efficacy of an extended remote monitoring intervention, including a TM app, HF nurse guided home care and multidisciplinary network collaboration using the Virtual Ward platform, on top of standard HF care…
ID
Source
Brief title
Condition
- Heart failures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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.
Background summary
Remote Monitoring (RM) or telemonitoring (TM) has been widely used in patients
with heart failure (HF) to monitor for signs and symptoms of worsening HF (WHF)
aiming to reduce HF (re)hospitalization rates. However, the efficacy of RM in
achieving this goal remains debatable as multiple randomized clinical trials
reported neutral outcomes opposed to meta-analyses demonstrating beneficial
effects of RM on HF (re)hospitalization rates. Previous studies differed in
study design, endpoints and organization of HF care and used a broad variety of
different RM modalities in distinct and heterogeneous HF patient populations,
which may explain the ambiguity in outcome results observed in RM trials and
registries. Nevertheless, continuous development of novel TM modalities, (HF)
nurse guided home care programs and multidisciplinary network collaborations
provide HF care specialists with new tools that could potentially contribute to
improved guidance and outcomes of HF patients. However, to demonstrate the
efficacy of RM and outpatient multidisciplinary home care based programs in
improving prognosis, the need for properly designed randomized controlled
clinical trials unequivocally remains. In this regard, the current study will
investigate the efficacy of a combined intervention including TM, HF nurse
guided home care and multidisciplinary network collaboration (using Virtual
Ward and cBoards system) in improving all-cause mortality and WHF events
(including HF hospitalizations, urgent HF visits and outpatient worsening) in
different WHF patient populations. Our hypothesis is that an extended and
comprehensive RM strategy on top of standard HF care, consisting of regular
outpatient cardiologist and HF nurse treatment and guidance, is superior to
standard HF care alone to reduce WHF events and mortality in patients with WHF.
Study objective
The primary objective is to demonstrate efficacy of an extended remote
monitoring intervention, including a TM app, HF nurse guided home care and
multidisciplinary network collaboration using the Virtual Ward platform, on top
of standard HF care consisting of regular outpatient cardiologist and HF nurse
treatment and guidance in patients with worsening heart failure.
Secondary and exploratory
Secundaire en exploratieve objectives include to determine the effect of the
intervention versus standard care on quality of life and cost-effectiveness of
the intervention.
Study design
A single center, prospective, unblinded, randomized clinical trial.
Intervention
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 platform using Virtual Ward and
cBoards.
Group 2: control group receiving standard heart failure care.
Study burden and risks
The burden of participating in the trial is limited to 4 study visits including
physical examination and a limited laboratory assessment that is part of the
standard heart failure care (so no additional laboratory assessments).
Furthermore, patients are asked to fill in two questionaires concerning quality
of life and the impact of heart failure symptoms at the start end end of study.
The intervention group will be asked to add measurements in the smartphone
application twice a week and will receive home visits by heart failure nurses
ranging from once a week to once every two weeks.
No potential harm is to be expected from using the Luscii or Virtual Ward
application and remote monitoring.
Oosterpark 9
Amsterdam 1091AC
NL
Oosterpark 9
Amsterdam 1091AC
NL
Listed location countries
Age
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
- 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) <20 ml/min (obtained within 2 weeks of the
baseline visit), refractory to diuretic therapy, or on chronic renal dialysis
- Unable to use and/or unavailability of a computer device or smart phone
application
- Simultaneous participation in any other intervention study or remote
monitoring programme is not allowed.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL81244.100.22 |