NCT06270953

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
54

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

January 19, 2024

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

February 13, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 21, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2024

Completed
Last Updated

September 29, 2025

Status Verified

February 1, 2024

Enrollment Period

3 months

First QC Date

February 13, 2024

Last Update Submit

September 23, 2025

Conditions

No Specific Medical Conditions or Disease States

Outcome Measures

Primary Outcomes (1)

  • Number of Care Escalation and/or Transfers (Subgroup- ER visits, Surgical Interventions & Hospitalizations, ICU Admissions),

    3 months

Secondary Outcomes (2)

  • HCP experience response data

    3 Months

  • Care pathway mapping

    3 Months

Study Arms (2)

Obervational group

Patients admitted in the SNF facility during the study period

Device: Dozee Pro NX

Control group

Historical control with patients admitted in the SNF before the study period

Interventions

Dozee Pro NXDEVICE

Dozee Pro NX to measure Heart Rate, Respiratory Rate, SPO2 and movements

Obervational group

Eligibility Criteria

Age18 Months - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oak Village Healthcare

Lake Jackson, Texas, 77566, United States

Location

Study Officials

  • Lindsay Darthard, LNFA

    Oak Village Healthcare

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

February 13, 2024

First Posted

February 21, 2024

Study Start

January 19, 2024

Primary Completion

April 30, 2024

Study Completion

June 30, 2024

Last Updated

September 29, 2025

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)