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Virtual vs. Traditional Physical Therapy Following Total Knee Replacement

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ClinicalTrials.gov Identifier: NCT02914210
Recruitment Status : Completed
First Posted : September 26, 2016
Last Update Posted : May 25, 2018
Sponsor:
Collaborator:
Reflexion Health, Inc.
Information provided by (Responsible Party):
Duke University

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.

Condition or disease Intervention/treatment Phase
Total Knee Replacement Device: Virtual physical therapy rehabilitation program Other: No intervention Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 305 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Virtual Exercise Rehabilitation In-home Therapy: A Randomized Study (VERITAS)
Actual Study Start Date : October 2016
Actual Primary Completion Date : March 2018
Actual Study Completion Date : March 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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

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




Primary Outcome Measures :
  1. Cost difference [ Time Frame: 90 days ]
    Difference in cost of the 90-day episode of care for total knee replacement between virtual therapy and traditional therapy


Secondary Outcome Measures :
  1. Knee Injury and Osteoarthritis Outcome Score (KOOS) [ Time Frame: 90 days ]
    KOOS score through 90 days after surgery

  2. Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health Score [ Time Frame: 90 days ]
    PROMIS Global Health score 90 days after surgery

  3. Number of falls [ Time Frame: 90 days ]
    Number of falls through 90 days after surgery

  4. Re-hospitalization [ Time Frame: 90 days ]
    Number of rehospitalizations through 90 days after surgery


Other Outcome Measures:
  1. Satisfaction with physical function [ Time Frame: 90 days ]
    Score on Satisfaction with Physical Function questionnaire through 90 days after surgery

  2. Physical activity [ Time Frame: 90 days ]
    Physical activity through 90 days after surgery

  3. Pain [ Time Frame: 90 days ]
    Pain score through 90 days after surgery

  4. Return to work [ Time Frame: 90 days ]
    Frequency of return to working status within 90 days, for those who stopped working prior to surgery

  5. Frequency of health service utilization [ Time Frame: 90 days ]
    Frequency of interactions with health services by type through 90 days after surgery

  6. Range of motion [ Time Frame: 6 weeks ]
    Range of motion 6 weeks after surgery

  7. Gait speed [ Time Frame: 6 weeks ]
    Gait speed 6 weeks after surgery



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02914210


Locations
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United States, North Carolina
University of North Carolina Orhthopedics
Chapel Hill, North Carolina, United States, 27514
Duke Orthopaedics
Durham, North Carolina, United States, 27705
Greensboro Orthopedics
Greensboro, North Carolina, United States, 27408
Raleigh Orthopaedics
Raleigh, North Carolina, United States, 27612
Sponsors and Collaborators
Duke University
Reflexion Health, Inc.
Investigators
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Principal Investigator: Janet Bettger, ScD Duke Clinical Research Institute, Duke Dept of Orthopaedic Surgery

Additional Information:
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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT02914210     History of Changes
Other Study ID Numbers: Pro00074409
First Posted: September 26, 2016    Key Record Dates
Last Update Posted: May 25, 2018
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Duke University:
TKR
TKA
Knee
Surgery
Replacement
Rehabilitation
Virtual
Physical Therapy
Telerehabilitation