Evaluation of Home-based Sensor System to Detect Health Decompensation in Elderly Patients With History of CHF or COPD

Recruiting

• Conditions: COPD Exacerbation; CHF; COPD; Chronic Obstructive Pulmonary Disease; Congestive Heart Failure
• Interventions: Other: Data collection

• Registration Number: NCT05865184
• Lead Sponsor: Sensorum Health Inc.

Brief Summary

Sensorum Health (Sensorum) is conducting a pilot study to determine if Sensorum's proprietary passive sensor network can be used to identify signals of early health decompensation in subjects prior to a hospitalization for chronic disease exacerbation or other ambulatory care sensitive conditions. Successful early detection would provide a window of opportunity to intervene outside of the acute setting in future interventional studies.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-09-28
• Status Verified: 2023-05
• Study First Submitted: 2023-05-03
• Study First Submitted QC: 2023-05-09
• Last Update Submitted: 2023-05-09
• Study First Posted: 2023-05-18
• Last Update Posted: 2023-05-18
• Primary Completion: 2024-06-06
• Study Completion: 2024-06-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Aged 65 years or older
• Able to consent
• Documented history of diagnosis of chronic obstructive pulmonary disease (COPD) and/or congestive heart failure (CHF)
• Currently admitted to JSUMC for observation or as an inpatient with any diagnosis ≥1 prior hospital utilization events with any diagnosis (inpatient admissions, facility observation stays, or ED visits) in the past 12 months

Exclusion Criteria

• Significant cardiac valvular disease
• End-Stage Renal Disease (ESRD)
• End-Stage CHF
• End-Stage COPD

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Passive monitoring	Data collection	No intervention

Primary Outcome Measures

Name	Time	Method
Precision of AI in passive sensor system	90 days	Evaluation of AI ability to precisely predict hospital utilization event
Recall of AI in passive sensor system	90 days	Evaluation of AI ability to prospectively detect hospital utilization event

Secondary Outcome Measures

Name	Time	Method
Recall of sensor data review by trained nurses	90 days	Evaluation of nurse ability to prospectively detect hospital utilization event
Precision of sensor data review by trained nurses	90 days	Evaluation of nurse ability to precisely predict hospital utilization event

Trial Locations

Locations (1)

Jersey Shore University Medical Center, Hackensack Meridian Health; 🇺🇸 Neptune, New Jersey, United States