Back to resultsResiliency in Total Joint Arthroplasty
Primary Purpose
Osteoarthritis
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
StreaMD
Sponsored by
About this trial
This is an interventional other trial for Osteoarthritis focused on measuring Total Hip Arthroplasty, Total Knee Arthroplasty, Patient Reported Outcomes, Resilience
Eligibility Criteria
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
Sites / Locations
- University of Utah Orthopaedic Center
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control
Intervention
Arm Description
No other non-standard of care activities will be performed
Will be signed up for the automated text messaging program (StreaMD)
Outcomes
Primary Outcome Measures
Patient Reported Outcome Score (PROMIS) following THA or TKA
Patient reported outcome will consist of the Patient-Reported Outcomes Measurement Information System (PROMIS)
Patient Reported Outcome Score (HOOS Jr.) following THA or TKA
Patient reported outcome will consist of the hip disability and osteoarthritis outcome score (HOOS Jr.)
Patient Reported Outcome Score (KOOS Jr.) following THA or TKA
Patient reported outcome will consist of the knee injury and osteoarthritis outcome score (KOOS Jr.)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04357262
Brief Title
Resiliency in Total Joint Arthroplasty
Official Title
Resiliency in Total Joint Arthroplasty
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
March 5, 2020 (Actual)
Primary Completion Date
January 12, 2022 (Actual)
Study Completion Date
January 12, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Utah
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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)?
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis
Keywords
Total Hip Arthroplasty, Total Knee Arthroplasty, Patient Reported Outcomes, Resilience
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
No Intervention
Arm Description
No other non-standard of care activities will be performed
Arm Title
Intervention
Arm Type
Experimental
Arm Description
Will be signed up for the automated text messaging program (StreaMD)
Intervention Type
Other
Intervention Name(s)
StreaMD
Intervention Description
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.
Primary Outcome Measure Information:
Title
Patient Reported Outcome Score (PROMIS) following THA or TKA
Description
Patient reported outcome will consist of the Patient-Reported Outcomes Measurement Information System (PROMIS)
Time Frame
Follow Up Visits up to 2-Years
Title
Patient Reported Outcome Score (HOOS Jr.) following THA or TKA
Description
Patient reported outcome will consist of the hip disability and osteoarthritis outcome score (HOOS Jr.)
Time Frame
Follow Up Visits up to 2-Years
Title
Patient Reported Outcome Score (KOOS Jr.) following THA or TKA
Description
Patient reported outcome will consist of the knee injury and osteoarthritis outcome score (KOOS Jr.)
Time Frame
Follow Up Visits up to 2-Years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeremy Gililland, M.D.
Organizational Affiliation
University of Utah
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Utah Orthopaedic Center
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84108
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Resiliency in Total Joint Arthroplasty
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