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

January 12, 2024 updated by: Sensorum Health Inc.

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 (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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10021
        • Recruiting
        • Weill Cornell Medicine
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Current Patient of PI's clinic at Weill Cornell Medicine

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Passive monitoring
No intervention
Other: Data collection
Data collection of clinically relevant signals using home-based sensor system

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recall of AI in passive sensor system
Time Frame: 6 months
Evaluation of AI ability to prospectively detect hospital utilization event
6 months
Precision of AI in passive sensor system
Time Frame: 6 months
Evaluation of AI ability to precisely predict hospital utilization event
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recall of sensor data review by trained nurses
Time Frame: 6 months
Evaluation of nurse ability to prospectively detect hospital utilization event
6 months
Precision of sensor data review by trained nurses
Time Frame: 6 months
Evaluation of nurse ability to precisely predict hospital utilization event
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sensorum Health Inc.

Investigators

  • Principal Investigator: Parag Goyal, M.D., MSc, Weill Medical College of Cornell University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 28, 2022

Primary Completion (Estimated)

August 1, 2024

Study Completion (Estimated)

September 1, 2024

Study Registration Dates

First Submitted

May 9, 2023

First Submitted That Met QC Criteria

May 9, 2023

First Posted (Actual)

May 18, 2023

Study Record Updates

Last Update Posted (Estimated)

January 15, 2024

Last Update Submitted That Met QC Criteria

January 12, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Sensorum P-002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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