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

NCT05865184 | Unknown

• 1 other identifier: Sensorum P-001
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

COPD; Chronic Obstructive Pulmonary Disease; COPD Exacerbation; CHF; Congestive Heart Failure

Outcome Measures

Primary Outcomes (2)

• Recall of AI in passive sensor system

  Evaluation of AI ability to prospectively detect hospital utilization event

  90 days

• Precision of AI in passive sensor system

  Evaluation of AI ability to precisely predict hospital utilization event

  90 days

Secondary Outcomes (2)

• Recall of sensor data review by trained nurses

  90 days

• Precision of sensor data review by trained nurses

  90 days

Study Arms (1)

Passive monitoring

No intervention

Other: Data collection

Interventions

Data collection OTHER

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

Passive monitoring

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients admitted as inpatient to Jersey Shore University Medical Center

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Sensorum Health Inc.: lead

Study Sites (1)

Jersey Shore University Medical Center, Hackensack Meridian Health

Neptune City, New Jersey, 07753, United States

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Heart Failure

Interventions

Data Collection

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Swapnel Patel, MD

  Jersey Shore University Medical Center, Hackensack Meridian Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christine Fernandez

CONTACT

(973) 786-3573; christine@sensorum.ai

Andrew Hotchkiss

CONTACT

(973) 946-8382; andrew@sensorum.ai

Study Design

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

Study Record Dates

• First Submitted: May 3, 2023
• First Posted: May 18, 2023
• Study Start: September 28, 2022
• Primary Completion: June 6, 2024
• Study Completion: June 6, 2024
• Last Updated: May 18, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)