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Adding Value in Knee Arthroplasty Post-total Knee Replacement (TKR) Care Navigator Trial (AViKA)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Elena Losina, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT01540851
First received: February 21, 2012
Last updated: January 22, 2016
Last verified: January 2016
Results First Received: December 16, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Osteoarthritis
Degenerative Joint Disease
Interventions: Behavioral: Care Navigator
Other: Standard Post-Operative TKA Care

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Subjects were recruited from a tertiary academic medical center in Boston, MA

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Care Navigator Intervention Group

Subjects randomized to the Care Navigator Intervention group will receive up to 10 telephone calls from a care navigator for 5 months post-operatively

Care Navigator: Subjects assigned to the Care Navigator intervention group will receive 10 calls from a care navigator after discharged from the hospital for 5 months after their total knee replacement.

Subjects assigned to the usual Care group will receive current standard of post-operative care

Usual Care Group

Subjects in the Usual Care group receive the current standard post-operative TKA care

Care Navigator: Subjects assigned to the Care Navigator intervention group will receive 10 calls from a care navigator after discharged from the hospital for 5 months after their total knee replacement.

Subjects assigned to the usual Care group will receive current standard of post-operative care


Participant Flow:   Overall Study
    Care Navigator Intervention Group     Usual Care Group  
STARTED     154     154  
COMPLETED     133     136  
NOT COMPLETED     21     18  
Lost to Follow-up                 14                 15  
Withdrawal by Subject                 7                 3  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Care Navigator Intervention Group

Subjects randomized to the Care Navigator Intervention group will receive up to 10 telephone calls from a care navigator for 5 months post-operatively

Care Navigator: Subjects assigned to the Care Navigator intervention group will receive 10 calls from a care navigator after discharged from the hospital for 5 months after their total knee replacement.

Subjects assigned to the usual Care group will receive current standard of post-operative care

Usual Care Group

Subjects in the Usual Care group receive the current standard post-operative TKA care

Care Navigator: Subjects assigned to the Care Navigator intervention group will receive 10 calls from a care navigator after discharged from the hospital for 5 months after their total knee replacement.

Subjects assigned to the usual Care group will receive current standard of post-operative care

Total Total of all reporting groups

Baseline Measures
    Care Navigator Intervention Group     Usual Care Group     Total  
Number of Participants  
[units: participants]
  154     154     308  
Age  
[units: years]
Mean (Standard Deviation)
  66  (8)     67  (8)     66  (8)  
Gender  
[units: participants]
     
Female     93     93     186  
Male     61     61     122  
Region of Enrollment  
[units: participants]
     
United States     154     154     308  
BMI  
[units: kg/m^2]
Mean (Standard Deviation)
  31  (6)     31  (6)     31  (6)  
WOMAC Physical Function score [1]
[units: units on a scale]
Mean (Standard Deviation)
  42  (16)     41  (19)     41  (17)  
WOMAC Pain score [2]
[units: units on a scale]
Mean (Standard Deviation)
  42  (16)     40  (19)     41  (18)  
[1] The WOMAC Physical Function scale is scaled from 0 to 100, with 100 worst
[2] The WOMAC Pain scale is scaled from 0 to 100, with 100 worst



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change in WOMAC Physical Function   [ Time Frame: Change in functional status from baseline to 6 months ]

2.  Secondary:   Satisfaction   [ Time Frame: Measured at 6 months post TKA ]

3.  Secondary:   Range of Motion   [ Time Frame: 6 months after TKA ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Elena Losina, PhD
Organization: Brigham and Women's Hospital
phone: 617-732-6928
e-mail: elosina@partners.org


Publications:

Responsible Party: Elena Losina, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT01540851     History of Changes
Other Study ID Numbers: 2010p002597
Study First Received: February 21, 2012
Results First Received: December 16, 2015
Last Updated: January 22, 2016
Health Authority: United States: Institutional Review Board