Testing of Mobile Monitoring System

November 20, 2023 updated by: Robin Kamal, Stanford University

To Implement and Test the Mobile Monitoring Tool to Identify SSI (R33 Phase)

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

500

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Orthopaedic surgery patient at hospital 175

Exclusion Criteria:

  • no access to mobile phone

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Mobile monitoring group
Behavioral: Mobile Monitoring Tool
a text-messaged based outcomes collection system

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Promis PF Short form (change in self reported capability)
Time Frame: 1 day, 1 week, 2 week, 4 week, 12 weeks after surgery
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
1 day, 1 week, 2 week, 4 week, 12 weeks after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stanford University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2024

Primary Completion (Estimated)

June 1, 2025

Study Completion (Estimated)

June 1, 2025

Study Registration Dates

First Submitted

September 8, 2020

First Submitted That Met QC Criteria

October 22, 2020

First Posted (Actual)

October 23, 2020

Study Record Updates

Last Update Posted (Actual)

November 22, 2023

Last Update Submitted That Met QC Criteria

November 20, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 57543

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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