Virtual vs. Traditional Physical Therapy Following Total Knee Replacement

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

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.

Study Overview

• Status: Completed
• Conditions: Total Knee Replacement
• Intervention / Treatment: Device: Virtual physical therapy rehabilitation program; Other: No intervention

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 306
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27514
      • University of North Carolina Orhthopedics
    • Durham, North Carolina, United States, 27705
      • Duke Orthopaedics
    • Greensboro, North Carolina, United States, 27408
      • Greensboro Orthopedics
    • Raleigh, North Carolina, United States, 27612
      • Raleigh Orthopaedics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. ≥ 18 years of age
2. Scheduled to have a non-traumatic TKR
3. Can be enrolled a minimum of 10 days prior to surgery (in-person visit)
4. Have a Risk Assessment and Prediction Tool (RAPT) score of ≥ 6 indicating expected discharge home after surgical hospitalization

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: Virtual physical therapy; 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; Virtual Exercise Rehabilitation Assistant (VERA), a virtual physical therapy delivery system installed in patient's home
OTHER: Traditional physical therapy; No intervention. Standard home health physical therapy and/or outpatient clinic physical therapy as prescribed.	Other: No intervention; Traditional physical therapy delivered in clinic or via home-health visits

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Knee Injury and Osteoarthritis Outcome Score (KOOS) Sub-domain Scores	Scores in KOOS sub-domains of pain, symptoms, activities of daily living (ADL), sports and recreation, and quality of life (QOL). Each sub-domain score can be normalized to values ranging from 0 to 100. Higher scores denote better outcomes.	6 weeks and 12 weeks
Physical Activity	Physical activity (duration of moderate exercise in total minutes per week)	6 weeks and 12 weeks
Return to Work	Return to work (yes, modified schedule, or no) for those who stopped working prior to surgery	6 weeks and 12 weeks
Patient-Reported Outcomes Measurement Information System (PROMIS) - Mental Health (MH) Score	PROMIS mental health score at 12 weeks, on a scale of 0 to 20 with higher scores indicating better mental health.	12 weeks
Patient-Reported Outcomes Measurement Information System (PROMIS) - Physical Health (PH) Score	PROMIS physical health score at 12 weeks, on a scale of 0 to 20, with higher scores indicating better physical health.	12 weeks
Satisfaction With Physical Function	Score on Satisfaction with Physical Function questionnaire through 12 weeks after surgery, on a scale of 0 to 6, with 6 being higher satisfaction.	12 weeks
Satisfaction With Tele-rehab Platform	Satisfaction with tele-rehab platform, on scale of 0 to 10, with 10 being highly satisfied.	12 weeks

Collaborators and Investigators

• Sponsor: Duke University
• Collaborators: Reflexion Health, Inc.
• Investigators: Principal Investigator: Janet Bettger, ScD, Duke Clinical Research Institute, Duke Dept of Orthopaedic Surgery

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 1, 2016
• Primary Completion (ACTUAL): March 1, 2018
• Study Completion (ACTUAL): March 1, 2018

Study Registration Dates

• First Submitted: September 15, 2016
• First Submitted That Met QC Criteria: September 22, 2016
• First Posted (ESTIMATE): September 26, 2016

Study Record Updates

• Last Update Posted (ACTUAL): November 2, 2021
• Last Update Submitted That Met QC Criteria: October 26, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: Rehabilitation; Surgery; Replacement; Knee; Physical Therapy; Telerehabilitation; Virtual; TKA; TKR
• Other Study ID Numbers: Pro00074409

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No