Ignite Creation Date:
2025-12-25 @ 3:53 AM
Ignite Modification Date:
2026-03-04 @ 5:59 AM
Study NCT ID:
NCT03059602
Status:
COMPLETED
Last Update Posted:
2019-07-17
First Post:
2017-02-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Biopsychosocial Impact on Caregivers in Patients Undergoing Joint and Spine Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 150}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-05-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2018-10-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-07-16', 'studyFirstSubmitDate': '2017-02-16', 'studyFirstSubmitQcDate': '2017-02-16', 'lastUpdatePostDateStruct': {'date': '2019-07-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-02-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-10-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Natural history of biopsychosocial impact of Caregivers', 'timeFrame': '1 month', 'description': 'To describe the natural history of the biopsychosocial impact of Caregivers for patients undergoing total knee arthroplasty, total hip arthroplasty, and cervical/thoracic/lumbar spinal surgery.'}], 'secondaryOutcomes': [{'measure': 'Change of biopsychosocial measures over time', 'timeFrame': '1 month', 'description': 'To assess the biopsychosocial measure over time from the following time points: Preoperative, 7 days, 14 days postoperatively, and 1 month postoperatively.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pain, Postoperative']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to describe the biopsychosocial impact of caregivers in patients undergoing total knee arthroplasty, total hip arthroplasty, and cervical/thoracic/lumbar spine surgery.Defining such impacts may offer opportunities to enhance caregiver capability to provide care following surgery on a loved one.', 'detailedDescription': 'This is a pilot feasibility study with the goal of enrolling 50 caregivers in each surgical subgroup, with a total of 150 subjects. Caregivers for patients undergoing the above surgeries will be administered Patient Reported Outcome Measurement Information System (PROMIS) measures preoperatively, 7 days postoperatively, 14 days postoperatively, and 1 month postoperatively. PROMIS item banks will include Global Health, Anxiety, Fatigue, Depression, Self Efficacy, Social Satisfaction, and Sleep Disturbance. If the caregiver reports the presence of persistent pain, Pain Interference and Physical Function will be administered.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Caregivers of male and female military health care beneficiaries age 18 years and older presenting for total knee arthroplasty, total hip arthroplasty, and Cervical/Thoracic/Lumbar spine surgery. Caregivers are defined as individuals who will be the primary source of assistance (medical, rehabilitative, daily living, etc) within the first 30 days after surgery.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years old or older\n* Are the primary person helping in the recovery of a patient undergoing one of the following surgeries below with in the first 30 days after surgery Total knee arthroplasty Total hip arthroplasty Cervical/Thoracic/Lumbar spine surgery\n* Able to understand English and can verbalize their pain level\n\nExclusion Criteria:\n\n* Younger than 18 years old\n* Refuse participation\n* Cannot understand English\n* Has cognitive deficiencies (subject unable to provide consent for the study, subject unable to complete initial post consent measures)'}, 'identificationModule': {'nctId': 'NCT03059602', 'briefTitle': 'Biopsychosocial Impact on Caregivers in Patients Undergoing Joint and Spine Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Defense and Veterans Center for Integrative Pain Management'}, 'officialTitle': 'Characterizing the Biopsychosocial Impact on Caregivers in Patients Undergoing Joint Replacement and Cervical/Thoracic/Lumbar Spine Surgery: A Pilot Study', 'orgStudyIdInfo': {'id': '500115'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Knee group', 'description': 'Caregivers who will be the primary source of assistance (medical, rehabilitative, daily living, etc) after surgery for patients undergoing total knee arthroplasty.', 'interventionNames': ['Other: No specific treatment based intervention-health measurement instrument']}, {'label': 'Hip group', 'description': 'Caregivers who will be the primary source of assistance (medical, rehabilitative, daily living, etc) after surgery for patients undergoing total hip arthroplasty.', 'interventionNames': ['Other: No specific treatment based intervention-health measurement instrument']}, {'label': 'Spine group', 'description': 'Caregivers who will be the primary source of assistance (medical, rehabilitative, daily living, etc) after surgery for patients undergoing Cervical/Thoracic Lumbar Spine Surgery (Discectomy, Foraminotomy, Laminectomy, Fusion, Nerve Root Decompression)', 'interventionNames': ['Other: No specific treatment based intervention-health measurement instrument']}], 'interventions': [{'name': 'No specific treatment based intervention-health measurement instrument', 'type': 'OTHER', 'description': "Caregivers will receive a series of standard health measurement tools/survey from NIH's Patient Reported Outcome Measurement Information System (PROMIS)", 'armGroupLabels': ['Hip group', 'Knee group', 'Spine group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20889', 'city': 'Bethesda', 'state': 'Maryland', 'country': 'United States', 'facility': 'Walter Reed National Military Medical Center', 'geoPoint': {'lat': 38.98067, 'lon': -77.10026}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Defense and Veterans Center for Integrative Pain Management', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}