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Testing of Mobile Monitoring System

Primary Purpose

Orthopedic Disorder

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Mobile Monitoring Tool
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Orthopedic Disorder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Orthopaedic surgery patient at hospital 175

Exclusion Criteria:

  • no access to mobile phone

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Mobile monitoring group

    Arm Description

    Outcomes

    Primary Outcome Measures

    Promis PF Short form (change in self reported capability)
    PROMIS Physical Function instruments measure self-reported capability rather than actual performance of physical activities. It is scored from 0-100, a higher score indicates better physical function

    Secondary Outcome Measures

    Full Information

    First Posted
    September 8, 2020
    Last Updated
    November 5, 2021
    Sponsor
    Stanford University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04601376
    Brief Title
    Testing of Mobile Monitoring System
    Official Title
    To Implement and Test the Mobile Monitoring Tool to Identify SSI (R33 Phase)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2021
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    January 2024 (Anticipated)
    Primary Completion Date
    June 2025 (Anticipated)
    Study Completion Date
    June 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Stanford University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    We will complete a prospective, observational study comparing the accuracy of the mobile monitoring tool on identifying SSI compared to manual review.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Orthopedic Disorder

    7. Study Design

    Primary Purpose
    Basic Science
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    500 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Mobile monitoring group
    Arm Type
    Experimental
    Intervention Type
    Behavioral
    Intervention Name(s)
    Mobile Monitoring Tool
    Intervention Description
    a text-messaged based outcomes collection system
    Primary Outcome Measure Information:
    Title
    Promis PF Short form (change in self reported capability)
    Description
    PROMIS Physical Function instruments measure self-reported capability rather than actual performance of physical activities. It is scored from 0-100, a higher score indicates better physical function
    Time Frame
    1 day, 1 week, 2 week, 4 week, 12 weeks after surgery

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Orthopaedic surgery patient at hospital 175 Exclusion Criteria: no access to mobile phone

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Testing of Mobile Monitoring System

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