Non-invasive Monitoring: Impact on Patient Management and Outcomes

Impact of Non-invasive Continuous Patient Monitoring System on Patient Management and Health Outcomes

Enhancing patient monitoring in SNFs and ALFs is crucial due to challenges in recognizing deteriorating health. Gaps in vital sign checks lead to missed indicators and adverse outcomes. Turtle Shell Technologies' Dozee Pro NX offers continuous non-invasive monitoring, alerting healthcare providers of vital sign changes. This clinical study aims to evaluate Dozee Pro Nx's impact on patient outcomes, practitioner efficiency, and healthcare costs in SNFs and ALFs, addressing gaps in care delivery.

Study Overview

• Status: Completed
• Conditions: No Specific Medical Conditions or Disease States
• Intervention / Treatment: Device: Dozee Pro NX

Detailed Description

In skilled nursing facilities (SNFs) and assisted living facilities (ALFs), managing patient health presents considerable hurdles in accurately identifying and responding to deteriorating conditions. The intricacies of care within these settings are compounded by a high patient-to-healthcare provider ratio, often leading to infrequent vital sign checks with significant time gaps between assessments. This monitoring gap may result in overlooking early signs of health decline, potentially causing adverse patient outcomes. A February 2014 report by the Office of Inspector General (OIG) underscored this issue, revealing that around 22% of Medicare beneficiaries experienced adverse events during their stays in SNFs, with an additional 11% facing temporary harm events. Notably, 59% of these incidents were considered preventable, largely due to insufficient patient monitoring, care delays, and substandard treatment. In response to these challenges, Turtle Shell Technologies (TST) Private Limited has developed Dozee Pro NX, an innovative system tailored to improve patient monitoring in these healthcare settings. This system employs non-invasive sensors to continuously monitor crucial parameters such as heart rate, respiration rate, blood pressure, temperature, and SpO2. Distinguished from traditional patient monitoring devices, Dozee Pro Nx offers advanced functionalities, including customizable notifications to alert healthcare providers of vital sign deterioration, thereby enabling prompt intervention. The primary objective of this clinical study is to evaluate the potential impact of the Dozee Pro Nx system on patient outcomes, healthcare practitioner efficiency, and overall healthcare costs. This investigation aims to ascertain whether the implementation of this advanced monitoring technology can effectively address the identified gaps in patient care within SNFs and ALFs, ultimately leading to improved health outcomes and enhanced care delivery.

• Study Type: Observational
• Enrollment (Actual): 54

Contacts and Locations

Study Locations

• United States
  • Texas
    • Lake Jackson, Texas, United States, 77566
      • Oak Village Healthcare

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The study will be conducted on subjects in the age group above 18 years regardless of gender. The study is done on patients admitted in the SNF who fulfill the inclusion and exclusion criteria

Description

Inclusion Criteria:

• Age 18 years or older.
• Weight between 40kg-120kgs

Exclusion Criteria:

• Terminal illness with a life expectancy of less than 1 month.
• Have any condition that could interfere with the subject's ability to lie flat or stable on the bed
• Needs the use of equipment whose operation can interfere with Investigation System operations
• Patients planned to be transferred from the facility within 72 hours
• Prisoners
• Pregnant

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Obervational group; Patients admitted in the SNF facility during the study period	Device: Dozee Pro NX; Dozee Pro NX to measure Heart Rate, Respiratory Rate, SPO2 and movements
Control group; Historical control with patients admitted in the SNF before the study period

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of Care Escalation and/or Transfers (Subgroup- ER visits, Surgical Interventions & Hospitalizations, ICU Admissions),	3 months

Secondary Outcome Measures

Outcome Measure	Time Frame
HCP experience response data	3 Months
Care pathway mapping	3 Months

Collaborators and Investigators

• Sponsor: Turtle Shell Technologies Pvt. Ltd.
• Investigators: Principal Investigator: Lindsay Darthard, LNFA, Oak Village Healthcare

Study record dates

Study Major Dates

• Study Start (Actual): January 19, 2024
• Primary Completion (Actual): April 30, 2024
• Study Completion (Actual): June 30, 2024

Study Registration Dates

• First Submitted: February 13, 2024
• First Submitted That Met QC Criteria: February 13, 2024
• First Posted (Actual): February 21, 2024

Study Record Updates

• Last Update Posted (Estimated): September 29, 2025
• Last Update Submitted That Met QC Criteria: September 23, 2025
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: DZ_NX_US

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No