NCT04480411

Brief Summary

The purpose of this study is to assess the use of technology including remote vital sign monitoring in improving quality of patient care, decreasing hospital admissions and re-admissions, decreasing hospital length of stay and decreasing use of personal protective equipment.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2022

Geographic Reach
1 country

1 active site

Status
withdrawn

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

First Submitted

Initial submission to the registry

July 17, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 21, 2020

Completed
1.4 years until next milestone

Study Start

First participant enrolled

January 1, 2022

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

January 31, 2022

Status Verified

January 1, 2022

Enrollment Period

11 months

First QC Date

July 17, 2020

Last Update Submit

January 14, 2022

Conditions

Keywords

Telemedicine

Outcome Measures

Primary Outcomes (4)

  • Patient provider experience survey score

    Five questions related to satisfaction with experience using home pulse oximetry, each on a scale of 1 (poor) to 5 (excellent) summed and averaged for an overall range of 1 to 5 (higher scores = better experience).

    Once after completion of device use (up to 15 minutes to complete the survey)

  • Provider experience survey score

    Four questions related to satisfaction with experience using home pulse oximetry, each on a scale of 1 (poor) to 5 (excellent) summed and averaged for an overall range of 1 to 4 (higher scores = better experience).

    Once after completion of device use (up to 15 minutes to complete the survey)

  • Use of personal protective improvement

    Level of personal protective improvement in an in-patient setting.

    6 months

  • Number of in-patient encounters with COVID patients as a measure of provider exposure to high risk illness

    6 months

Study Arms (1)

COVID-19 Patients

EXPERIMENTAL

Patients that are admitted to the hospital with COVID 19.

Behavioral: Doctorgram Patient Kit

Interventions

Participants will use the Doctorgram Patient Kit for remote monitoring and remote use stethoscope.

COVID-19 Patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Hospitalized patient with COVID 19 or outpatient under investigation for or diagnosed with COVID 19
  • Clinically stable (on 4L O2 or less, non ICU)
  • Demonstrates ability to be trained in use of digital stethoscope technology

You may not qualify if:

  • Pregnancy
  • Delirium

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford University

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Ritu Parikh, MD

    Stanford University

    PRINCIPAL INVESTIGATOR
  • Julieta M Gabiola, MD

    Stanford University

    PRINCIPAL INVESTIGATOR
  • Nicholas Scoulios, MD

    Stanford University

    PRINCIPAL INVESTIGATOR
  • Lisa Shieh, MD

    Stanford University

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 17, 2020

First Posted

July 21, 2020

Study Start

January 1, 2022

Primary Completion

December 1, 2022

Study Completion

December 1, 2022

Last Updated

January 31, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share

Locations