Ignite Creation Date:
2025-12-24 @ 11:49 PM
Ignite Modification Date:
2026-02-25 @ 8:25 PM
Study NCT ID:
NCT01540851
Status:
COMPLETED
Last Update Posted:
2018-02-09
First Post:
2012-02-21
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Adding Value in Knee Arthroplasty Post-total Knee Replacement (TKR) Care Navigator Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'elosina@partners.org', 'phone': '617-732-6928', 'title': 'Elena Losina, PhD', 'organization': "Brigham and Women's Hospital"}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Care Navigator Intervention Group', 'description': 'Subjects randomized to the Care Navigator Intervention group will receive up to 10 telephone calls from a care navigator for 5 months post-operatively\n\nCare 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.\n\nSubjects assigned to the usual Care group will receive current standard of post-operative care', 'otherNumAtRisk': 154, 'otherNumAffected': 0, 'seriousNumAtRisk': 154, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Usual Care Group', 'description': 'Subjects in the Usual Care group receive the current standard post-operative TKA care\n\nCare 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.\n\nSubjects assigned to the usual Care group will receive current standard of post-operative care', 'otherNumAtRisk': 154, 'otherNumAffected': 0, 'seriousNumAtRisk': 154, 'seriousNumAffected': 1}], 'seriousEvents': [{'term': 'Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 154, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in WOMAC Physical Function', 'denoms': [{'units': 'Participants', 'counts': [{'value': '133', 'groupId': 'OG000'}, {'value': '136', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Care Navigator Intervention Group', 'description': 'Subjects randomized to the Care Navigator Intervention group will receive up to 10 telephone calls from a care navigator for 5 months post-operatively\n\nCare 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.\n\nSubjects assigned to the usual Care group will receive current standard of post-operative care'}, {'id': 'OG001', 'title': 'Usual Care Group', 'description': 'Subjects in the Usual Care group receive the current standard post-operative TKA care\n\nCare 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.\n\nSubjects assigned to the usual Care group will receive current standard of post-operative care'}], 'classes': [{'categories': [{'measurements': [{'value': '-30', 'groupId': 'OG000', 'lowerLimit': '-33', 'upperLimit': '-27'}, {'value': '-27', 'groupId': 'OG001', 'lowerLimit': '-30', 'upperLimit': '-23'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change in functional status from baseline to 6 months', 'description': 'The change in functional status will be measured using the WOMAC Physical Function scale at Baseline and 6 months', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The WOMAC Physical Function scale is scaled from 0 to 100, with 100 worst. Change in function was calculated as the WOMAC Physical Function score at 6 months minus the WOMAC Physical Function score at baseline'}, {'type': 'SECONDARY', 'title': 'Satisfaction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '133', 'groupId': 'OG000'}, {'value': '136', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Care Navigator Intervention Group', 'description': 'Subjects randomized to the Care Navigator Intervention group will receive up to 10 telephone calls from a care navigator for 5 months post-operatively'}, {'id': 'OG001', 'title': 'Usual Care Group', 'description': 'Subjects in the Usual Care group receive the current standard post-operative TKA care'}], 'classes': [{'categories': [{'measurements': [{'value': '80', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Measured at 6 months post TKA', 'description': 'Percentage of patients in each study arm who reported being very satisfied with the results of TKA', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The proportion of participants who reported being very satisfied with the results of TKA was assessed using a 5-item Likert scale on the 6 month follow-up questionnaire'}, {'type': 'SECONDARY', 'title': 'Range of Motion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '133', 'groupId': 'OG000'}, {'value': '136', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Care Navigator Intervention Group', 'description': 'Subjects randomized to the Care Navigator Intervention group will receive up to 10 telephone calls from a care navigator for 5 months post-operatively'}, {'id': 'OG001', 'title': 'Usual Care Group', 'description': 'Subjects in the Usual Care group receive the current standard post-operative TKA care'}], 'classes': [{'categories': [{'measurements': [{'value': '70', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 months after TKA', 'description': 'Percentage of participants able to bend knee at least 120 degrees', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Percentage of participants who self-reported on their 6 month questionnaire that they were able to bend their index knee to greater than 120 degrees'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Care Navigator Intervention Group', 'description': 'Subjects randomized to the Care Navigator Intervention group will receive up to 10 telephone calls from a care navigator for 5 months post-operatively\n\nCare 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.\n\nSubjects assigned to the usual Care group will receive current standard of post-operative care'}, {'id': 'FG001', 'title': 'Usual Care Group', 'description': 'Subjects in the Usual Care group receive the current standard post-operative TKA care\n\nCare 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.\n\nSubjects assigned to the usual Care group will receive current standard of post-operative care'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '154'}, {'groupId': 'FG001', 'numSubjects': '154'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '133'}, {'groupId': 'FG001', 'numSubjects': '136'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '18'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '15'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '3'}]}]}], 'recruitmentDetails': 'Subjects were recruited from a tertiary academic medical center in Boston, MA'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '154', 'groupId': 'BG000'}, {'value': '154', 'groupId': 'BG001'}, {'value': '308', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Care Navigator Intervention Group', 'description': 'Subjects randomized to the Care Navigator Intervention group will receive up to 10 telephone calls from a care navigator for 5 months post-operatively\n\nCare 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.\n\nSubjects assigned to the usual Care group will receive current standard of post-operative care'}, {'id': 'BG001', 'title': 'Usual Care Group', 'description': 'Subjects in the Usual Care group receive the current standard post-operative TKA care\n\nCare 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.\n\nSubjects assigned to the usual Care group will receive current standard of post-operative care'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '66', 'spread': '8', 'groupId': 'BG000'}, {'value': '67', 'spread': '8', 'groupId': 'BG001'}, {'value': '66', 'spread': '8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '93', 'groupId': 'BG000'}, {'value': '93', 'groupId': 'BG001'}, {'value': '186', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '61', 'groupId': 'BG000'}, {'value': '61', 'groupId': 'BG001'}, {'value': '122', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '154', 'groupId': 'BG000'}, {'value': '154', 'groupId': 'BG001'}, {'value': '308', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'BMI', 'classes': [{'categories': [{'measurements': [{'value': '31', 'spread': '6', 'groupId': 'BG000'}, {'value': '31', 'spread': '6', 'groupId': 'BG001'}, {'value': '31', 'spread': '6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'WOMAC Physical Function score', 'classes': [{'categories': [{'measurements': [{'value': '42', 'spread': '16', 'groupId': 'BG000'}, {'value': '41', 'spread': '19', 'groupId': 'BG001'}, {'value': '41', 'spread': '17', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The WOMAC Physical Function scale is scaled from 0 to 100, with 100 worst', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'WOMAC Pain score', 'classes': [{'categories': [{'measurements': [{'value': '42', 'spread': '16', 'groupId': 'BG000'}, {'value': '40', 'spread': '19', 'groupId': 'BG001'}, {'value': '41', 'spread': '18', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The WOMAC Pain scale is scaled from 0 to 100, with 100 worst', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 308}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-07-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-01', 'completionDateStruct': {'date': '2014-05-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-01-16', 'studyFirstSubmitDate': '2012-02-21', 'resultsFirstSubmitDate': '2015-12-16', 'studyFirstSubmitQcDate': '2012-02-23', 'lastUpdatePostDateStruct': {'date': '2018-02-09', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2016-01-22', 'studyFirstPostDateStruct': {'date': '2012-02-29', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-02-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-05-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in WOMAC Physical Function', 'timeFrame': 'Change in functional status from baseline to 6 months', 'description': 'The change in functional status will be measured using the WOMAC Physical Function scale at Baseline and 6 months'}], 'secondaryOutcomes': [{'measure': 'Satisfaction', 'timeFrame': 'Measured at 6 months post TKA', 'description': 'Percentage of patients in each study arm who reported being very satisfied with the results of TKA'}, {'measure': 'Range of Motion', 'timeFrame': '6 months after TKA', 'description': 'Percentage of participants able to bend knee at least 120 degrees'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Osteoarthritis', 'Total Knee Replacement', 'total Knee Arthroplasty', 'Post operative recovery, TKA', 'Post-operative recovery TKR', 'Care Navigator'], 'conditions': ['Osteoarthritis', 'Degenerative Joint Disease']}, 'referencesModule': {'references': [{'pmid': '24119081', 'type': 'BACKGROUND', 'citation': 'Losina E, Collins JE, Daigle ME, Donnell-Fink LA, Prokopetz JJ, Strnad D, Lerner V, Rome BN, Ghazinouri R, Skoniecki DJ, Katz JN, Wright J. The AViKA (Adding Value in Knee Arthroplasty) postoperative care navigation trial: rationale and design features. BMC Musculoskelet Disord. 2013 Oct 12;14:290. doi: 10.1186/1471-2474-14-290.'}, {'pmid': '26714179', 'type': 'RESULT', 'citation': 'Losina E, Collins JE, Wright J, Daigle ME, Donnell-Fink LA, Strnad D, Usiskin IM, Yang HY, Lerner V, Katz JN. Postoperative Care Navigation for Total Knee Arthroplasty Patients: A Randomized Controlled Trial. Arthritis Care Res (Hoboken). 2016 Sep;68(9):1252-9. doi: 10.1002/acr.22829. Epub 2016 Jul 28.'}]}, 'descriptionModule': {'briefSummary': 'The objectives of this research are to:\n\nConduct a proof of concept randomized controlled trial with up to 300 patients undergoing primary total knee replacement (TKA) at Brigham and Women\'s Hospital (BWH). The trial will compare a "Care Navigator" post-discharge intervention versus "Usual Care" post discharge management of patients undergoing TKA. The intervention will focus on the challenging process of transitions from the acute care hospital to inpatient or outpatient rehabilitation, and from inpatient rehabilitation to home.\n\nThe principal goals of the trial are:\n\n1. To establish whether "Care Navigator" intervention improves functional outcomes as compared with the "Usual Care" treatment six months after TKA surgery.\n2. To establish whether "Care Navigator" intervention is cost effective six months after TKA surgery.\n\nThe investigators hypothesize that:\n\n1. Incorporating the Care Navigator role into the "Usual Care" treatment will increase TKA patients\' rate of adherence to the rehabilitation protocol and improve functional outcomes.\n2. Addition of a Care Navigator is cost-effective.', 'detailedDescription': 'The "Post-TKA Care Navigator" proof of concept intervention will be implemented as a randomized controlled trial. The investigators aim to identify and enroll a cohort of up to 300 subjects who have decided to undergo total knee replacement (TKA) at BWH. Subjects will be patients of the five orthopedic surgeons at Brigham and Women\'s Hospital who perform the most TKAs: Drs. Wright, Brick, Ready, Martin and Thornhill. Subjects will be followed from about two weeks prior to the operation to six months after discharge.\n\nThe investigators will assign patients into two groups, at random: 1) receiving current standard of post-operative care and 2) adding "Post-TKA Care Navigator". The role of the Care Navigator will be to follow up with patients via frequent telephone conversations, ranging from weekly during the first month to bi-weekly for the next 6 weeks to monthly by the 14th week post op. subjects assigned to the care navigator will receive up to 10 telephone calls over a period of 5 months. The goal of the Care Navigator would be to ensure or encourage compliance with physical therapy, triage patient concerns, questions and complaints, and identify those patients that require a call from a clinician to address a problem in the recovery process. For those issues that can be resolved easily at home the navigator would suggest strategies. The value of the post-TKA Care Navigator will be assessed by comparing functional status, satisfaction with surgery, utilization of health care, adherence to physical therapy, range of knee motion and intervention costs across the two randomized groups.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Scheduled to undergo primary TKA at Brigham \\& Women's Hospital\n* Osteoarthritis is the principal underlying diagnosis\n* Age \\>=40 at the projected date of TKA\n* English-speaking\n\nExclusion Criteria:\n\n* Osteoarthritis is not the principal underlying diagnosis (e.g. inflammatory arthritis)\n* Dementia\n* Psychological issues that preclude participation, as identified by participating surgeons\n* Non-English speaker\n* Diagnosis other than Osteoarthritis or secondary Osteoarthritis\n* Age \\< 40 at the projected date of TKA\n* Lives in a nursing home\n* Implantation of Unicompartamental Knee Arthroscopy or Interpositional Arthroplasty\n* Bilateral TKA in same admission (simultaneous)or planned bilateral within 6 months"}, 'identificationModule': {'nctId': 'NCT01540851', 'acronym': 'AViKA', 'briefTitle': 'Adding Value in Knee Arthroplasty Post-total Knee Replacement (TKR) Care Navigator Trial', 'organization': {'class': 'OTHER', 'fullName': "Brigham and Women's Hospital"}, 'officialTitle': 'Adding Value in Knee Arthroplasty Post TKR Care Navigator Trial', 'orgStudyIdInfo': {'id': '2010p002597'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Care Navigator Intervention Group', 'description': 'Subjects randomized to the Care Navigator Intervention group will receive up to 10 telephone calls from a care navigator for 5 months post-operatively', 'interventionNames': ['Behavioral: Care Navigator']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Usual Care Group', 'description': 'Subjects in the Usual Care group receive the current standard post-operative TKA care', 'interventionNames': ['Other: Standard Post-Operative TKA Care']}], 'interventions': [{'name': 'Care Navigator', 'type': 'BEHAVIORAL', 'description': 'Subjects assigned to the Care Navigator intervention group will receive 10 calls from a care navigator after discharge from the hospital for 5 months after their total knee replacement.', 'armGroupLabels': ['Care Navigator Intervention Group']}, {'name': 'Standard Post-Operative TKA Care', 'type': 'OTHER', 'description': 'Subjects assigned to the Standard Post-Operative TKA Care group will receive the current standard of care for post-operative care', 'armGroupLabels': ['Usual Care Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Brigham & Women's Hospital", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Elena Losina, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Brigham and Women's Hospital"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Brigham and Women's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD, Principal Investigator', 'investigatorFullName': 'Elena Losina', 'investigatorAffiliation': "Brigham and Women's Hospital"}}}}