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Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date October 2021
Source Duke University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Virtual physical therapy rehabilitation program
Virtual Exercise Rehabilitation Assistant (VERA), a virtual physical therapy delivery system installed in patient's home
Other:
No intervention
Traditional physical therapy delivered in clinic or via home-health visits

Locations

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

Sponsors (2)

Lead Sponsor Collaborator
Duke University Reflexion Health, Inc.

Country where clinical trial is conducted

United States, 

Outcome

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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