Clinical trial NCT05217420: Moving Well for Total Knee Arthroplasty (TKA)
Official title: Moving Well Intervention for Patients Preparing to Undergo Total Knee Arthroplasty (TKA)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Osteoarthritis, Knee
Keywords: arthroplasty
replacement
peer coach
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
Collaborators: name: Rheumatology Research Foundation
name: Hospital for Special Surgery, New York
First posted: 2022-02-01
Enrollment: 79
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to assess the efficacy of a behavioral intervention, Moving Well, in improving levels of anxiety and depression for patients undergoing total knee arthroplasty (TKA).

Detailed description: Moving Well is a behavioral intervention, guided by peer coaches, that aims to improve mental and physical preparation for patients planning to undergo total knee arthroplasty (TKA) and improve postoperative recovery and outcomes. Peer coaches are patients who themselves have had TKA due to advanced osteoarthritis (OA) of the knee and have been trained and certified to become peer coaches.

Eligibility criteria: Inclusion Criteria:

* Subjects must have their primary TKR (one knee or both knees) scheduled in 8 weeks or more
* Be willing to participate in the Moving Well (intervention) arm or Staying Well (attention control) arm
* Are willing to work with a coach
* ≥ 50 years of age
* Speak English
* Have access to the internet, computer, and a working phone
* We will prioritize the recruitment of subjects with low socioeconomic status defined as being a beneficiary of Medicaid or no insurance and an underrepresented racial/ethnic group (Hispanic/Black).

Exclusion Criteria:

* Non-English speakers
* The intervention will first be delivered in English to ensure feasibility with the content before adapting the material for patients who speak other languages.
* TKR was a result of a septic joint or revision (implant malfunction)
* Unable to exercise (e.g., bed bound or wheelchair bound)
* Have had contralateral TKR or other joint replacement surgery (hip, shoulder) within the past 5 years
* If they have RA or other connective tissue disease: Lupus, ankylosing spondylitis, psoriatic arthritis, scleroderma, infectious arthritis, polymyalgia rheumatica.

Primary outcomes:
measure: Change in level of anxiety from baseline using the Generalized Anxiety Disorder Assessment (GAD-7)
timeFrame: Baseline, 6 months post-surgery
measure: Change in level of depression from baseline using the Patient Health Questionnaire-8 (PHQ-8)
timeFrame: Baseline, 6 months post-surgery
Secondary outcomes:
measure: Change in level of social support from baseline using the Lubben Social Network Scale-18 (LSNS-18)
timeFrame: Baseline, 6 months post-surgery
measure: Change in general health status from baseline using the 12-Item Short Form Survey (SF-12)
timeFrame: Baseline, 6 months post-surgery
measure: Change in level of pain catastrophizing from baseline using the Pain Catastrophizing Scale (PCS).
timeFrame: Baseline, 6 months post-surgery
measure: Change in level of knee pain and function from baseline using the Knee Injury and Osteoarthritis Outcome Score (KOOS) pain sub-scale.
timeFrame: Baseline, 6 months post-surgery
measure: Change in level of self-efficacy from baseline using the General Self-Efficacy Scale (GSF)
timeFrame: Baseline, 6 months post-surgery
measure: Change in sleep disturbance from baseline using the Patient-Reported Outcomes Information System (PROMIS) Sleep Disturbance Scale.
timeFrame: Baseline, 6 months post-surgery
measure: Change in opioid use for knee pain from baseline using participant self-report
timeFrame: Baseline, 6 months post-surgery
measure: Duration of post-surgery inpatient rehabilitation using the number of days of inpatient rehabilitation
timeFrame: 6 months post-surgery
measure: Change in knee range of motion from baseline using a goniometer
timeFrame: Baseline, 6 months post-surgery
measure: Change in Timed Up and Go test (TUG) from baseline
timeFrame: Baseline, 6 months post-surgery
measure: Change in 6-minute walk test (6MWT) from baseline
timeFrame: Baseline, 6 months post-surgery
measure: Change in 30-second chair to stand test from baseline
timeFrame: Baseline, 6 months post-surgery
measure: Change in quadriceps strength from baseline using a handheld dynamometer (HHD)
timeFrame: Baseline, 6 months post-surgery
Other outcomes:
Locations:
city: New York
country: United States
facility: Weill Cornell Medicine Clinical & Translational Science Center
state: New York
Study officials:
affiliation: Weill Medical College of Cornell University
name: Iris Y Navarro Millan, MD, MSPH
role: PRINCIPAL_INVESTIGATOR
References: