Heart Failure Acute, Telemonitoring
Conditions
Keywords
heart failure, acute decompensation, telemedicine, telemonitoring
Brief summary
Heart failure (HF) is a growing global public health concern. Worldwide, the estimated prevalence of HF has increased to \>64.3 million cases. Despite improvement in outcomes with medication, HF is a leading cause of hospitalization among individuals \>65 years. Approximately 30-40% of HF patients have a history of hospitalization, and 50% are re- admitted with 1 year within their initial diagnosis of HF . In Tunisia, the current statistics (2017) show that the all-cause 1-year mortality rate among acute HF patient was 22.8%, the 1-year rate of hospitalization because of HF was 7.3%, and the 1-year incidence rates of the combined event (all-cause mortality or HF hospitalization) was 18.7%. Available literature highlighted that patient monitoring using wearable biosensors is a promising strategy to improve cardiovascular patients care and have potential to support clinical practice and improve patient outcomes . The objective of this protocol is to evaluate the feasibility and effectiveness of continuous tele- ECG monitoring in predicting hospital readmission and other clinical relevant outcome in patients with AF discharged from the emergency department (ED) after HF decompensation using a novel device "VIVALINK ECG Patch".
Interventions
DEVICEECG Monitoting
Participants will be provided with a chest-worn biosensor ECG patch (Vivalink's multi-vital wearable ECG monitor, VIVALINK California, USA) , which collects real-time continuous ECG and heart rate variability. This multi-function cardiac patch can live stream multiple parameters to a mobile device or the cloud. It is reusable, rechargeable. The related platform offers both raw vital and analysis data: (1) Raw vital data records the ECG, heart rate, respiratory rate, and acceleration with timestamps, (2) Analysis data: arrhythmia detection. Continuous monitoring will be insured for 30 days after patient discharge to identify patients potentially at risk of hospital readmission. The daily statistics include mean heart rate, mean respiratory rate, acceleration index, number of premature ventricular contractions and ventricular arrythmia and other potential arrhythmias.
Sponsors
University of Monastir
Vivalink
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Inclusion criteria
(1) Patients having an HF decompensation diagnosis, patients with reduced ejection fraction\<50%, (2) having a documented AF (3) have a plan for discharging with partnering home health services, (4) agree to use the wearable ECG patch for 30 days (5) with a permanent residential address (6) without significant cognitive impairment and (7) understand English language. \-
Exclusion criteria
(1) patients having implanted pacemaker or any electrical devices; (2) having an allergy to hydrocolloid gel adhesive or skin diseases; (3) unstable vital signs, (4) being on dialysis; (5) having a documented visual, cognitive, or physical impairment that would interfere with the ability to comply with the study procedures, (6) pregnant women (7) having inability to give an informed consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Readmission | 30 days | Hospital readmission and death after ED discharge. Factors associated with hospital readmission and death will be determined. |
Countries
Tunisia
Outcome results
None listed