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

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

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 Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05865184
• Other study ID #: Sensorum P-001
• Status: Recruiting
• Start date: September 28, 2022
• Est. completion date: June 6, 2024

Study information

• Verified date: May 2023
• Source: Sensorum Health Inc.
• Contact: Christine Fernandez
• Phone: (973) 786-3573
• Email: christine[@]sensorum.ai
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: June 6, 2024
• Est. primary completion date: June 6, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• CHF
• Chronic Obstructive Pulmonary Disease
• Congestive Heart Failure
• COPD
• COPD Exacerbation
• Heart Failure
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

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

Locations

Country	Name	City	State
United States	Jersey Shore University Medical Center, Hackensack Meridian Health	Neptune	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Sensorum Health Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recall of AI in passive sensor system	Evaluation of AI ability to prospectively detect hospital utilization event	90 days
Primary	Precision of AI in passive sensor system	Evaluation of AI ability to precisely predict hospital utilization event	90 days
Secondary	Recall of sensor data review by trained nurses	Evaluation of nurse ability to prospectively detect hospital utilization event	90 days
Secondary	Precision of sensor data review by trained nurses	Evaluation of nurse ability to precisely predict hospital utilization event	90 days