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Clinical Trials/NCT05865197
NCT05865197RecruitingNot Applicable

Feasibility of Home-based, Ambient Passive Sensor Technology to Provide Early Warning of Health Decompensation by Detecting Deviations in Activities of Daily Living (ADLs) of Elderly Subjects With Diagnosed Chronic Heart Failure

Sensorum Health Inc.1 site in 1 country20 target enrollmentStarted: November 28, 2022Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
20
Locations
1
Primary Endpoint
Recall of AI in passive sensor system

Study Overview

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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
55 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Current Patient at Weill Cornell Medicine
  • Aged 55 years or older
  • Able to consent
  • Documented diagnosis of congestive heart failure (CHF)
  • At least 1 of the following prior hospital utilization events in the past 12 months
  • Inpatient admission for any reason
  • Facility observation stay for any reason
  • Emergency Department visit for any reason

Exclusion Criteria

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

Outcomes

Primary Outcomes

Recall of AI in passive sensor system

Time Frame: 6 months

Evaluation of AI ability to prospectively detect hospital utilization event

Precision of AI in passive sensor system

Time Frame: 6 months

Evaluation of AI ability to precisely predict hospital utilization event

Secondary Outcomes

  • Recall of sensor data review by trained nurses(6 months)
  • Precision of sensor data review by trained nurses(6 months)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

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