Early Detection of Health Deterioration in Elderly Patients After Hospitalization for Heart Failure Decompensation

NCT ID: NCT06126848

Last Updated: 2023-11-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-31

Study Completion Date

2026-03-31

Brief Summary

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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)

Detailed Description

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Conditions

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Heart Failure

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Observation Cohort

Group Type OTHER

Ambient sensor system

Intervention Type 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.

Interventions

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Ambient sensor system

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.

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nisha Arenja

OTHER

Sponsor Role lead

Responsible Party

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Nisha Arenja

Pinciple Investigator

Responsibility Role SPONSOR_INVESTIGATOR

References

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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.

Reference Type DERIVED
PMID: 40824685 (View on PubMed)

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.

Reference Type DERIVED
PMID: 38820577 (View on PubMed)

Other Identifiers

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eHealth-HF

Identifier Type: -

Identifier Source: org_study_id

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