Resiliency in Total Joint Arthroplasty

Sponsor

University of Utah (Other)

Overall Status

Completed

CT.gov ID

NCT04357262

Collaborator

(none)

Enrollment

Location

Arms

22.3

Actual Duration (Months)

0.8

Patients Per Site Per Month

Study Details

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)?

Condition or Disease	Intervention/Treatment	Phase
Osteoarthritis	Other: StreaMD	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

18 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

Resiliency in Total Joint Arthroplasty

Actual Study Start Date :

Mar 5, 2020

Actual Primary Completion Date :

Jan 12, 2022

Actual Study Completion Date :

Jan 12, 2022

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 90 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Utah Orthopaedic Center	Salt Lake City	Utah	United States	84108

Sponsors and Collaborators

University of Utah

Investigators

Principal Investigator: Jeremy Gililland, M.D., University of Utah

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Jeremy Gililland, Principle Investigator, University of Utah

ClinicalTrials.gov Identifier:

NCT04357262

Other Study ID Numbers:

129070

First Posted:

Apr 22, 2020

Last Update Posted:

Jul 15, 2022

Last Verified:

Jul 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Jeremy Gililland, Principle Investigator, University of Utah

Total Hip Arthroplasty

Total Knee Arthroplasty

Patient Reported Outcomes

Resilience

Additional relevant MeSH terms:

Osteoarthritis

Study Results

No Results Posted as of Jul 15, 2022