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Virtual vs. Traditional Physical Therapy Following Total Knee Replacement

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02914210
Recruitment Status : Completed
First Posted : September 26, 2016
Results First Posted : January 18, 2020
Last Update Posted : January 18, 2020
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 : 306 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 in US Dollars [ Time Frame: 12 weeks ]
    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.


Secondary Outcome Measures :
  1. Knee Injury and Osteoarthritis Outcome Score (KOOS) [ Time Frame: 6 weeks and 12 weeks ]
    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.

  2. Range of Motion [ Time Frame: 6 weeks ]
    Knee range of motion [lower (extension) and upper range of motion (flexion)] at 6 weeks

  3. 10-meter Gait Speed [ Time Frame: 6 weeks ]
    Gait speed 6 weeks after surgery

  4. Pain Score [ Time Frame: 12 weeks ]
    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.

  5. Report of Falls [ Time Frame: 12 weeks ]
    Any fall reported between hospital discharge and 12-week follow-up (yes/no)

  6. Re-hospitalization [ Time Frame: 12 weeks ]
    Re-hospitalizations since hospital discharge (total count)


Other Outcome Measures:
  1. Knee Injury and Osteoarthritis Outcome Score (KOOS) Sub-domain Scores [ Time Frame: 6 weeks and 12 weeks ]
    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.

  2. Physical Activity [ Time Frame: 6 weeks and 12 weeks ]
    Physical activity (duration of moderate exercise in total minutes per week)

  3. Return to Work [ Time Frame: 6 weeks and 12 weeks ]
    Return to work (yes, modified schedule, or no) for those who stopped working prior to surgery

  4. Patient-Reported Outcomes Measurement Information System (PROMIS) - Mental Health (MH) Score [ Time Frame: 12 weeks ]
    PROMIS mental health score at 12 weeks, on a scale of 0 to 20 with higher scores indicating better mental health.

  5. Patient-Reported Outcomes Measurement Information System (PROMIS) - Physical Health (PH) Score [ Time Frame: 12 weeks ]
    PROMIS physical health score at 12 weeks, on a scale of 0 to 20, with higher scores indicating better physical health.

  6. Satisfaction With Physical Function [ Time Frame: 12 weeks ]
    Score on Satisfaction with Physical Function questionnaire through 12 weeks after surgery, on a scale of 0 to 6, with 6 being higher satisfaction.

  7. Satisfaction With Tele-rehab Platform [ Time Frame: 12 weeks ]
    Satisfaction with tele-rehab platform, on scale of 0 to 10, with 10 being highly satisfied.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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
  Study Documents (Full-Text)

Documents provided by Duke University:
Study Protocol  [PDF] March 2, 2017
Statistical Analysis Plan  [PDF] May 8, 2018
Informed Consent Form  [PDF] August 17, 2016


Additional Information:
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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT02914210    
Other Study ID Numbers: Pro00074409
First Posted: September 26, 2016    Key Record Dates
Results First Posted: January 18, 2020
Last Update Posted: January 18, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Duke University:
TKR
TKA
Knee
Surgery
Replacement
Rehabilitation
Virtual
Physical Therapy
Telerehabilitation