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).
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Enrollment
79
Experimental arm
Active comparator arm
Weill Cornell Medicine Clinical & Translational Science Center
New York, New York, United States
Change in level of anxiety from baseline using the Generalized Anxiety Disorder Assessment (GAD-7)
The GAD-7 is a 7 item self-reported questionnaire for screening and severity measuring of generalized anxiety disorder. Scores range from 0 to 21, with higher scores indicating greater severity of anxiety.
Time frame: Baseline, 6 months post-surgery
Change in level of depression from baseline using the Patient Health Questionnaire-8 (PHQ-8)
The PHQ-8 is a 8 item scale that screens for depression. Scores range from 0 to 24 with higher scores indicating greater severity of depression.
Time frame: Baseline, 6 months post-surgery
Change in level of social support from baseline using the Lubben Social Network Scale-18 (LSNS-18)
The LSNS-18 is a 18 item scale that measures perceived social support. Scores range from 0 to 90 with higher scores indicating greater social engagement.
Time frame: Baseline, 6 months post-surgery
Change in general health status from baseline using the 12-Item Short Form Survey (SF-12)
The SF-12 is a 12 item scale that assesses general health status. Scores range from 0 to 100 with higher scores indicating better physical and mental health functioning.
Time frame: Baseline, 6 months post-surgery
Change in level of pain catastrophizing from baseline using the Pain Catastrophizing Scale (PCS).
The PCS is a 13 item scale that assesses the level of catastrophic thinking related to an individual's pain. Scores range from 0 to 52 with higher scores indicating a higher level of pain-related anxiety.
Time frame: Baseline, 6 months post-surgery
Change in level of knee pain and function from baseline using the Knee Injury and Osteoarthritis Outcome Score (KOOS) pain sub-scale.
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The KOOS pain sub-scale is a 9 item scale that assesses knee pain. Scores range from 0 to 100 with lower scores indicating greater severity of pain. The KOOS function sub-scale is a 17 item scale that assesses function. Scores range from 0 to 100 with lower scores indicating worse knee function.
Time frame: Baseline, 6 months post-surgery
Change in level of self-efficacy from baseline using the General Self-Efficacy Scale (GSF)
The GSF is a 10 item scale that assesses perceived self-efficacy. Scores range from 10 to 40 with higher scores indicating a higher level of self-efficacy.
Time frame: Baseline, 6 months post-surgery
Change in sleep disturbance from baseline using the Patient-Reported Outcomes Information System (PROMIS) Sleep Disturbance Scale.
The PROMIS Sleep Disturbance Scale is a 8 item scale that measure self-reported perceptions of sleep quality, depth, and restoration within the past seven days. Scores range from with higher scores indicating greater sleep disturbances.
Time frame: Baseline, 6 months post-surgery
Change in opioid use for knee pain from baseline using participant self-report
Self-reported use of opioids for knee pain
Time frame: Baseline, 6 months post-surgery
Duration of post-surgery inpatient rehabilitation using the number of days of inpatient rehabilitation
Self-reported duration of inpatient rehabilitation
Time frame: 6 months post-surgery
Change in knee range of motion from baseline using a goniometer
A goniometer measures the range of motion at a joint. Measurement ranges from 0 to 180 degrees with higher range indicating greater range of motion.
Time frame: Baseline, 6 months post-surgery
Change in Timed Up and Go test (TUG) from baseline
The Timed Up and Go test is used to assess mobility. Completing the test in more than 12 seconds indicates a greater risk of falling in older adults.
Time frame: Baseline, 6 months post-surgery
Change in 6-minute walk test (6MWT) from baseline
The 6MWT is used to assess aerobic capacity and endurance. The distance covered by walking for 6 minutes is measured and used to compare changes in performance capacity.
Time frame: Baseline, 6 months post-surgery
Change in 30-second chair to stand test from baseline
The 30-second chair to stand test assesses leg strength and endurance. Scoring is based on the number of stands with a lower than average number indicating a greater risk of falls.
Time frame: Baseline, 6 months post-surgery
Change in quadriceps strength from baseline using a handheld dynamometer (HHD)
A handheld dynamometer is a device that measures muscle strength. Scores range from 0-300 pounds (upper limit can vary based on the device) with higher scores indicating greater quadriceps muscle strength.
Time frame: Baseline, 6 months post-surgery