Early Detection of Health Deterioration in Elderly Patients After Hospitalization for Heart Failure Decompensation: A Potential Role for Ambient Sensor Systems in the Patients Home
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Heart Failure
- Sponsor
- Nisha Arenja
- Enrollment
- 24
- Primary Endpoint
- Sensitivity and specificity of ambient sensor derived digital biomarkers
- Status
- Not Yet Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
Digital biomarkers extracted by ambient sensor signals are a promising tool for early detection of health deterioration in the setting of remote patient management of heart failure patients.The primary objective of the study is to evaluate new digital biomarkers as predictors of impending heart failure decompensation.
Secondary objectives are (1) outcome assessment (re-hospitalizations, cardiovascular death, all-cause death), (2) quality of life and (3) System User Satisfaction (SUS)
Investigators
Nisha Arenja
Pinciple Investigator
Kantonsspital Olten
Eligibility Criteria
Inclusion Criteria
- •admitted to hospital for worsening HF
- •age ≥ 70 years
- •LVEF \< 50% and need of diuretics
- •NYHA II or III
- •living alone
- •willing to participate with informed consent.
Exclusion Criteria
- •Major depression (PHQ 9-score \>9)
- •being on hemodialysis
- •had been admitted to hospital for any reason within 7 days before HF decompensation.
- •patients with a left ventricular assist device
- •coronary revascularization or cardiac resynchronization therapy implantation within 28 days before the index event of HF decompensation or have been scheduled for such interventions.
Outcomes
Primary Outcomes
Sensitivity and specificity of ambient sensor derived digital biomarkers
Time Frame: 6 months
Sensitivity and specificity of a combination of ambient sensor derived digital biomarker for the prediction of brain natriuretic peptide (BNP) increase of ≥ 20% compared to baseline value.
Secondary Outcomes
- Outcome assessment(6 months)
- Quality of life (heart failure symptoms) - KCCQ(6 months)
- System Usability Scale (SUS)(6 months)