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

NCT06126848 | Not Yet Recruiting

• 1 other identifier: eHealth-HF
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

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)

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Outcome assessment

  6 months

• Quality of life (heart failure symptoms) - KCCQ

  6 months

• System Usability Scale (SUS)

  6 months

Study Arms (1)

Observation Cohort

OTHER

Device: Ambient sensor system

Interventions

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.

Observation Cohort

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nisha Arenja: lead

Related Publications (2)

• 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.

  PMID: 40824685 DERIVED

• 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.

  PMID: 38820577 DERIVED

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Pinciple Investigator

Study Record Dates

• First Submitted: November 6, 2023
• First Posted: November 13, 2023
• Study Start: January 1, 2024
• Primary Completion: December 1, 2025
• Study Completion: March 1, 2026
• Last Updated: November 14, 2023

Record last verified: 2023-11