Therefore, in this study, we would like to investigate the clinical effectiveness of a smart technology intervention (The Heart Failure Box) in heart failure patients from the department of Cardiology at Leiden University Medical Center.
ID
Source
Brief title
Condition
- Heart failures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary Objective: The primary objective of the study will be to investigate
whether smart technology in the form of The Heart Failure Box can decrease the
number of cardiac decompensation-related visits to the emergency department
and/or- outpatient clinic, hospital admissions for decompensation and heart
failure related, when compared to standard care, measured until 1 year after
patients start using the smart technology.
Secondary outcome
Secondary Objective(s):
1. Quality of life
2. Patient satisfaction of care
3. Re-admission for heart failure
4. Cost-effectiveness
5. Time to admission for decompensation
6. Duration of admission
7. Total duration of decompensation phase
8. Admission for other causes
9. Overall mortality
10. Major adverse cardiac events
a. Cardiac death
b. Myocardial infarction
c. Ischaemic stroke
Background summary
Currently, heart failure patients are advised to regularly monitor their weight
and contact the outpatient clinic when experiencing symptoms of heart failure.
Nonetheless, 32% of patients are admitted within 30 days after the diagnosis
heart failure has been made and 25% of heart failure patients are readmitted
within the first month after an admission for heart failure, indicating a need
for improved early warning for heart failure. A scientific statement of the AHA
regarding transitions of care in heart failure shows that patients have
difficulties recognizing symptoms and are uncertain when it comes to
unsupervised self-monitoring. As a consequence, patients often contact the
outpatient clinic too late with a higher risk of hospitalization. Smart
technology (The Box) can support patients by giving them more insight into
their own health status and may identify disease worsening at an early stage,
which can lead to timely detection and treatment, possibly reducing
hospitalization for decompensation.
Study objective
Therefore, in this study, we would like to investigate the clinical
effectiveness of a smart technology intervention (The Heart Failure Box) in
heart failure patients from the department of Cardiology at Leiden University
Medical Center.
Study design
This is a study with a before-after comparison.
Study burden and risks
Patients will have to measure their weight, temperature, blood pressure and
heart rate on a regular basis. In addition they will use a sleepsensor and
activity tracker. Regularly, they also will be asked questions about their
general health and to monitor their fluid intake. They will fill in the
Minnesota Living with Heart Failure Questionnaire (MLHFQ) when receiving the
devices at the start of the study and 1 year afterwards. Patients who have an
left ventricular assist device will be asked additional questions about the
function of their device and necessary medication. These activities may take
some of their time.
All devices used by patients for personal management in this study are
non-invasive, easy-to-use and electrically safe within its intended use. Using
the devices is with very limited risks.
This study has some potential benefits for patients: First, patients can
measure their own blood pressure, pulse and weight, which can reassure patients
and give them more insight in their own health (the so-called *patient
empowerment*). Furthermore, this data gives the doctor more insight in the
health status of patients, potentially leading to earlier detection of heart
failure progression, hypotension or arrhythmias such as atrial fibrillation.
Due to the video connection system for e-consults, patients will not have to
come to the hospital for an extra consult, which saves the patient both time
and money.
Albinusdreef 2
Leiden 2333 ZA
NL
Albinusdreef 2
Leiden 2333 ZA
NL
Listed location countries
Age
Inclusion criteria
-Patient has heart failure according to the ESC guideline
-Patient is able to communicate in English or Dutch
-Patient is treated in the outpatient clinic by a cardiologist from the Leiden
University Medical Center
Exclusion criteria
-Patient is < 18 years old
-Patient is pregnant
-Patient does not have internet access at home
-Patient is considered an incapacitated adult
-Patient is unwilling to sign the informed consent form
Design
Recruitment
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| Other | Netherlands Trial Register Trial NL8492 |
| CCMO | NL73432.058.20 |
| OMON | NL-OMON26613 |