Virtual vs. Traditional Physical Therapy Following Total Knee Replacement

Study Overview
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Brief Summary
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The goals of this research study are the following: 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. To compare tele-rehabilitation-supported physical therapy and traditional physical therapy on patient-centered outcomes To explore whether individual patient characteristics are associated with differential improvement from 6 to 12 weeks assessed by patient-reported outcomes.

Detailed Description
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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.

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

Conditions
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Total Knee Replacement

Intervention / Treatment
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* Device: Virtual physical therapy rehabilitation program
* Other: No intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ≥ 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Virtual physical therapy<br>Virtual physical therapy rehabilitation program (VERA) used in the home with care planning and remote support and monitoring by physical therapists | Device: Virtual physical therapy rehabilitation program<br>* Virtual Exercise Rehabilitation Assistant (VERA), a virtual physical therapy delivery system installed in patient's home<br>|
| Other: Traditional physical therapy<br>No intervention. Standard home health physical therapy and/or outpatient clinic physical therapy as prescribed. | Other: No intervention<br>* Traditional physical therapy delivered in clinic or via home-health visits<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cost Difference in US Dollars | 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. | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Knee Injury and Osteoarthritis Outcome Score (KOOS) | Survey regarding health [Knee Injury and Osteoarthritis Outcome Score (KOOS)] for pain, symptoms, activities of daily living, function in sports and recreation, and knee-related quality of life (QOL) at 6 weeks and 12 weeks, scored from 0 to 100. Higher score indicates better outcomes. | 6 weeks and 12 weeks | 
| Range of Motion | Knee range of motion [lower (extension) and upper range of motion (flexion)] at 6 weeks | 6 weeks | 
| 10-meter Gait Speed | Gait speed 6 weeks after surgery | 6 weeks | 
| Pain Score | Non-inferiority safety endpoint: pain score at 12 weeks. Measured on scale from 0 to 10, with 0 being no pain and 10 being worst pain imaginable. | 12 weeks | 
| Report of Falls | Any fall reported between hospital discharge and 12-week follow-up (yes/no) | 12 weeks | 
| Re-hospitalization | Re-hospitalizations since hospital discharge (total count) | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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TKR, TKA, Knee, Surgery, Replacement, Rehabilitation, Virtual, Physical Therapy, Telerehabilitation