Moving Well Intervention for Patients Preparing to Undergo Total Knee Arthroplasty (TKA)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 101
- 试验地点
- 2
- 主要终点
- Change in level of depression from baseline using the Patient Health Questionnaire-8 (PHQ-8)
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
盲法说明
Only research team members who will collect objective in-person data will be masked
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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.
研究组 & 干预措施
Moving Well
Participants will receive weekly calls for 12 weeks (7 weeks before total knee arthroplasty surgery and 5 weeks after surgery) from a peer coach, an exercise program, and mental preparation (through positive thinking) for surgery. Participants will also receive the standard of care for patients undergoing total knee arthroplasty.
干预措施: Moving Well (Behavioral)
Staying Well
Participants will receive weekly calls for 12 weeks (7 weeks before total knee arthroplasty surgery and 5 weeks after surgery) from a research assistant. The calls will be similar in length to those in the experimental arm and will cover various health topics not related to total knee arthroplasty. Participants will also receive the standard of care for patients undergoing total knee arthroplasty.
干预措施: Staying Well (Behavioral)
结局指标
主要结局
Change in level of depression from baseline using the Patient Health Questionnaire-8 (PHQ-8)
时间窗: Baseline, 6 months post-surgery
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.
Change in level of anxiety from baseline using the Generalized Anxiety Disorder Assessment (GAD-7)
时间窗: Baseline, 6 months post-surgery
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.
次要结局
- Duration of post-surgery inpatient rehabilitation using the number of days of inpatient rehabilitation(6 months post-surgery)
- Change in level of social support from baseline using the Lubben Social Network Scale-18 (LSNS-18)(Baseline, 6 months post-surgery)
- Change in level of self-efficacy from baseline using the General Self-Efficacy Scale (GSF)(Baseline, 6 months post-surgery)
- Change in opioid use for knee pain from baseline using participant self-report(Baseline, 6 months post-surgery)
- Change in general health status from baseline using the 12-Item Short Form Survey (SF-12)(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.(Baseline, 6 months post-surgery)
- Change in sleep disturbance from baseline using the Patient-Reported Outcomes Information System (PROMIS) Sleep Disturbance Scale.(Baseline, 6 months post-surgery)
- Change in level of pain catastrophizing from baseline using the Pain Catastrophizing Scale (PCS).(Baseline, 6 months post-surgery)
- Change in 30-second chair to stand test from baseline(Baseline, 6 months post-surgery)
- Change in knee range of motion from baseline using a goniometer(Baseline, 6 months post-surgery)
- Change in 6-minute walk test (6MWT) from baseline(Baseline, 6 months post-surgery)
- Change in quadriceps strength from baseline using a handheld dynamometer (HHD)(Baseline, 6 months post-surgery)
- Change in Timed Up and Go test (TUG) from baseline(Baseline, 6 months post-surgery)