Clinical trial NCT02914210: Virtual vs. Traditional Physical Therapy Following Total Knee Replacement
Official title: Virtual Exercise Rehabilitation In-home Therapy: A Randomized Study (VERITAS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Total Knee Replacement
Keywords: TKR
TKA
Knee
Surgery
Replacement
Rehabilitation
Virtual
Physical Therapy
Telerehabilitation
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: Reflexion Health, Inc.
First posted: 2016-09-26
Enrollment: 306
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Cost Difference in US Dollars
timeFrame: 12 weeks
Secondary outcomes:
measure: Knee Injury and Osteoarthritis Outcome Score (KOOS)
timeFrame: 6 weeks and 12 weeks
measure: Range of Motion
timeFrame: 6 weeks
measure: 10-meter Gait Speed
timeFrame: 6 weeks
measure: Pain Score
timeFrame: 12 weeks
measure: Report of Falls
timeFrame: 12 weeks
measure: Re-hospitalization
timeFrame: 12 weeks
Other outcomes:
measure: Knee Injury and Osteoarthritis Outcome Score (KOOS) Sub-domain Scores
timeFrame: 6 weeks and 12 weeks
measure: Physical Activity
timeFrame: 6 weeks and 12 weeks
measure: Return to Work
timeFrame: 6 weeks and 12 weeks
measure: Patient-Reported Outcomes Measurement Information System (PROMIS) - Mental Health (MH) Score
timeFrame: 12 weeks
measure: Patient-Reported Outcomes Measurement Information System (PROMIS) - Physical Health (PH) Score
timeFrame: 12 weeks
measure: Satisfaction With Physical Function
timeFrame: 12 weeks
measure: Satisfaction With Tele-rehab Platform
timeFrame: 12 weeks
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina Orhthopedics
state: North Carolina
city: Durham
country: United States
facility: Duke Orthopaedics
state: North Carolina
city: Greensboro
country: United States
facility: Greensboro Orthopedics
state: North Carolina
city: Raleigh
country: United States
facility: Raleigh Orthopaedics
state: North Carolina
Study officials:
affiliation: Duke Clinical Research Institute, Duke Dept of Orthopaedic Surgery
name: Janet Bettger, ScD
role: PRINCIPAL_INVESTIGATOR
References: