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临床试验/NCT02914210
NCT02914210已完成不适用

Virtual Exercise Rehabilitation In-home Therapy: A Randomized Study (VERITAS)

Duke University8 个研究点 分布在 1 个国家目标入组 306 人开始时间: 2016年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
306
试验地点
8
主要终点
Cost Difference in US Dollars

研究概览

简要总结

The goals of this research study are the following:

  1. To compare the effects of tele-rehabilitation-supported physical therapy versus traditional home and/or clinic-based physical therapy for total knee replacement (TKR) on 90-day health service use costs.
  2. To compare tele-rehabilitation-supported physical therapy and traditional physical therapy on patient-centered outcomes
  3. To explore whether individual patient characteristics are associated with differential improvement from 6 to 12 weeks assessed by patient-reported outcomes.

详细描述

This study will compare the effects on health service use costs of tele-rehabilitation-supported physical therapy versus traditional home and/or clinic-based physical therapy following total knee replacement (TKR) surgery. It will also examine standard post-surgical clinical measures to confirm non-inferiority of outcomes between groups. A total of 300 patients will receive standard pre- and post-surgical medical care from their healthcare providers, and be randomized to receive pre-surgery rehabilitation exercises ("pre-hab") and post-discharge physical therapy provided via either a home-based tele-rehabilitation platform (intervention group, n=150) or home-health and clinic-based physical therapy regimen (control group, n=150). Data will be collected by sites at enrollment, baseline, hospital discharge, and 6 weeks following surgery. Patients will complete telephone surveys regarding their health and knee function at baseline, 6 weeks, and 3 months after surgery. Patients will also keep a diary from hospital discharge through 3 months documenting healthcare utilization and progress toward a personal recovery goal. Diary information will be collected over the phone concurrently with administration of the 6-week and 3-month surveys. The episode for analysis will be from surgery through 3 months post-discharge, in alignment with the Centers for Medicare and Medicaid Services Comprehensive Care for Joint Replacement (CJR) bundled payment model. Physical risks or benefits to patients for participating in this study are as expected from standard pre- and post-surgical physical therapy associated with total knee replacement surgery. The low risk of loss of confidentiality for all subjects will be minimized using appropriate safeguards.

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
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • ≥ 18 years of age
  • Scheduled to have a non-traumatic TKR
  • Can be enrolled a minimum of 10 days prior to surgery (in-person visit)
  • Have a Risk Assessment and Prediction Tool (RAPT) score of ≥ 6 indicating expected discharge home after surgical hospitalization

排除标准

  • Unable or unwilling to provide informed consent, including but not limited to cognitive or language barriers (comprehension)
  • Scheduled for staged bilateral TKR
  • Living in a nursing home prior to surgery

结局指标

主要结局

Cost Difference in US Dollars

时间窗: 12 weeks

Difference in total health service use costs at 12-weeks postoperative between patients who receive tele-rehab-supported PT versus traditional home and/or clinic-based PT for TKR.

次要结局

  • Knee Injury and Osteoarthritis Outcome Score (KOOS)(6 weeks and 12 weeks)
  • Range of Motion(6 weeks)
  • Report of Falls(12 weeks)
  • Re-hospitalization(12 weeks)
  • 10-meter Gait Speed(6 weeks)
  • Pain Score(12 weeks)

研究者

发起方
Duke University
申办方类型
Other
责任方
Sponsor

研究点 (8)

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