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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)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Observation Cohort | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ambient sensor system | Device | Main study: A contactless non-intrusive ambient sensor system including infrared motion sensors combined with a contactless Emfit bed sensor will be installed in the home of single living study patients by using a commercially available System (Domo Health®, Lausanne) after informed consent has been obtained. Sensor data are prospectively followed over 3-6 months for predefined indicators of health deterioration. If indicators for health deterioration are present, patients will be called in to the hospital for cardiology consult by the study team including blood analysis for follow-up of BNP values and if necessary, therapy adaption. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Outcome assessment | re-hospitalizations, cardiovascular death, all-cause death | 6 months |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40824685 | Derived | Haas K, Scheidegger-Balmer F, Meichtry A, Vogeli B, Arenja N, Buluschek P, Saner H. Association Between Refrigerator Openings and Protein Intake After Hospitalization for Heart Failure Decompensation: Protocol for a Prospective Cohort Pilot Study. JMIR Res Protoc. 2025 Aug 18;14:e66299. doi: 10.2196/66299. | |
| 38820577 | Derived |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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|
| 6 months |
| 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 |
| Vogeli B, Arenja N, Schutz N, Nef T, Buluschek P, Saner H. Evaluation of Ambient Sensor Systems for the Early Detection of Heart Failure Decompensation in Older Patients Living at Home Alone: Protocol for a Prospective Cohort Study. JMIR Res Protoc. 2024 May 31;13:e55953. doi: 10.2196/55953. |