NCT05865197

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 28, 2022

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 9, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 18, 2023

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2024

Completed
Last Updated

January 16, 2024

Status Verified

January 1, 2024

Enrollment Period

1.7 years

First QC Date

May 9, 2023

Last Update Submit

January 12, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • Recall of AI in passive sensor system

    Evaluation of AI ability to prospectively detect hospital utilization event

    6 months

  • Precision of AI in passive sensor system

    Evaluation of AI ability to precisely predict hospital utilization event

    6 months

Secondary Outcomes (2)

  • Recall of sensor data review by trained nurses

    6 months

  • Precision of sensor data review by trained nurses

    6 months

Study Arms (1)

Passive monitoring

No intervention

Other: Data collection

Interventions

Data collection of clinically relevant signals using home-based sensor system

Passive monitoring

Eligibility Criteria

Age55 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Current Patient of PI's clinic at Weill Cornell Medicine

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Weill Cornell Medicine

New York, New York, 10021, United States

RECRUITING

MeSH Terms

Conditions

Heart Failure

Interventions

Data Collection

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Parag Goyal, M.D., MSc

    Weill Medical College of Cornell University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Christine Fernandez

CONTACT

Andrew Hotchkiss

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 9, 2023

First Posted

May 18, 2023

Study Start

November 28, 2022

Primary Completion

August 1, 2024

Study Completion

September 1, 2024

Last Updated

January 16, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations