Heart Failure Clinical Trial
Official title:
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
Verified date | November 2023 |
Source | Kantonsspital Olten |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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)
Status | Not yet recruiting |
Enrollment | 24 |
Est. completion date | March 2026 |
Est. primary completion date | December 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 70 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Nisha Arenja |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Sensitivity and specificity of ambient sensor derived digital biomarkers | 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. | 6 months | |
Secondary | Outcome assessment | re-hospitalizations, cardiovascular death, all-cause death | 6 months | |
Secondary | Quality of life (heart failure symptoms) - KCCQ | KCCQ scores are scaled from 0 to 100 and frequently summarized in 25-point ranges, where scores represent health status as follows: 0 to 24: very poor to poor; 25 to 49: poor to fair; 50 to 74: fair to good; and 75 to 100: good to excellent. | 6 months | |
Secondary | System Usability Scale (SUS) | SUS score 0-100; 80.3 or higher is an A. People will recommend it to their friends 68 or there abouts gets you a C. You are doing OK but could improve 51 or under gets you a big fat F. Make usability your priority now and fix this fast. | 6 months |
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