Resiliency in Total Joint Arthroplasty

July 13, 2022 updated by: Jeremy Gililland, University of Utah
The investigators primary objective is to determine how does participation in StreaMD affect patient reported outcomes after Total Hip Arthroplasty (THA) or Total Knee Arthroplasty (TKA)?

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Osteoarthritis is a leading cause of disability in the US. By conservative estimates, about 54 million adults in the US have doctor-diagnosed arthritis. The number of people expected to have arthritis by the year 2040 is more than 78 million. Total joint arthroplasty is considered the treatment of choice for end-stage osteoarthritis. Currently, more than 1 million hip and knee replacements are performed each year in the US. By 2030, primary THR is projected to grow 171% and primary TKR is projected to grow by up to 189%, for a projected 635,000 and 1.28 million procedures, respectively. The incidence of pre-operative psychological distress in this group of patients is reported between 30% and 60% and preoperative psychological distress is associated with poorer pain and functional outcomes after surgery. Resilience, characterized by an ability to bounce back or recover from stress, is increasingly recognized as a psychometric property affecting many outcomes' domains including outcomes after TJA. Better resilience could improve patients overall satisfaction with the procedure.

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Utah
      • Salt Lake City, Utah, United States, 84108
        • University of Utah Orthopaedic Center

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 to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • All patients aged 18 and older who are receiving a total hip or knee replacement.

Exclusion Criteria:

  • Patients enrolled in the MyMobility study
  • Patients who do not have cell phones with text messaging capability
  • Non-English speaking patients

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: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
No other non-standard of care activities will be performed
Experimental: Intervention
Will be signed up for the automated text messaging program (StreaMD)
Other: StreaMD
Patients who are randomized to the intervention arm will be signed up for the automated text messaging program. Patients will receive automated text messages related to their surgery during the study period and can also ask questions through the text messages program, where automated messages will be sent based on the questions asked.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Reported Outcome Score (PROMIS) following THA or TKA
Time Frame: Follow Up Visits up to 2-Years
Patient reported outcome will consist of the Patient-Reported Outcomes Measurement Information System (PROMIS)
Follow Up Visits up to 2-Years
Patient Reported Outcome Score (HOOS Jr.) following THA or TKA
Time Frame: Follow Up Visits up to 2-Years
Patient reported outcome will consist of the hip disability and osteoarthritis outcome score (HOOS Jr.)
Follow Up Visits up to 2-Years
Patient Reported Outcome Score (KOOS Jr.) following THA or TKA
Time Frame: Follow Up Visits up to 2-Years
Patient reported outcome will consist of the knee injury and osteoarthritis outcome score (KOOS Jr.)
Follow Up Visits up to 2-Years

Collaborators and Investigators

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

Sponsor

University of Utah

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 (Actual)

March 5, 2020

Primary Completion (Actual)

January 12, 2022

Study Completion (Actual)

January 12, 2022

Study Registration Dates

First Submitted

April 15, 2020

First Submitted That Met QC Criteria

April 21, 2020

First Posted (Actual)

April 22, 2020

Study Record Updates

Last Update Posted (Actual)

July 15, 2022

Last Update Submitted That Met QC Criteria

July 13, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 129070

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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