Total Knee Replacement Clinical Trial
Official title:
Virtual Exercise Rehabilitation In-home Therapy: A Randomized Study (VERITAS)
NCT number | NCT02914210 |
Other study ID # | Pro00074409 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | October 2016 |
Est. completion date | March 2018 |
Verified date | October 2021 |
Source | Duke University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 306 |
Est. completion date | March 2018 |
Est. primary completion date | March 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | University of North Carolina Orhthopedics | Chapel Hill | North Carolina |
United States | Duke Orthopaedics | Durham | North Carolina |
United States | Greensboro Orthopedics | Greensboro | North Carolina |
United States | Raleigh Orthopaedics | Raleigh | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Duke University | Reflexion Health, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | 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 | |
Other | Physical Activity | Physical activity (duration of moderate exercise in total minutes per week) | 6 weeks and 12 weeks | |
Other | Return to Work | Return to work (yes, modified schedule, or no) for those who stopped working prior to surgery | 6 weeks and 12 weeks | |
Other | 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 | |
Other | 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 | |
Other | 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 | |
Other | Satisfaction With Tele-rehab Platform | Satisfaction with tele-rehab platform, on scale of 0 to 10, with 10 being highly satisfied. | 12 weeks | |
Primary | 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 | 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 | |
Secondary | Range of Motion | Knee range of motion [lower (extension) and upper range of motion (flexion)] at 6 weeks | 6 weeks | |
Secondary | 10-meter Gait Speed | Gait speed 6 weeks after surgery | 6 weeks | |
Secondary | 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 | |
Secondary | Report of Falls | Any fall reported between hospital discharge and 12-week follow-up (yes/no) | 12 weeks | |
Secondary | Re-hospitalization | Re-hospitalizations since hospital discharge (total count) | 12 weeks |
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