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
Health condition
Heart Failure
Research involving
Sponsors and support
Intervention
- Medical device
Outcome measures
Primary outcome
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, and hospital admissions for decompensation 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. IschaemÃc 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. 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. This is a study with abefore-after comparison.
Study objective
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
12 months
Intervention
Patients who consent to take part in the study receive a box containing a weight scale, thermometer, activity tracker, sleep sensor and a blood pressure monitor. All data will be measured regularly by the patient and uploaded into a mobile app which is accessible for both patient and caregiver. In addition patients will be asked questions about their general health and to monitor their fluid intake.
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
IPD sharing statement
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL8492 |
| CCMO | NL73432.058.20 |
| OMON | NL-OMON49254 |