Virtual vs. Traditional Physical Therapy Following Total Knee Replacement

Total Knee Replacement Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02914210
• Other study ID #: Pro00074409
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Total Knee Replacement

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