Ignite Creation Date:
2025-12-25 @ 5:04 AM
Ignite Modification Date:
2026-02-28 @ 10:52 PM
Study NCT ID:
NCT03834818
Status:
RECRUITING
Last Update Posted:
2025-06-26
First Post:
2019-02-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Collecting Outcomes and Managing Pain After Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Patients undergoing orthopedic surgery at Duke Health will be eligible for enrollment. Additionally, all potential participants must be an adult at least 18 years of age, speak and read English, own a smartphone they are willing to use for the study, and live in the United States of America. All study assessments will take place on the app and other than baseline screening all assessments will take place after surgery until the patient stops taking opioids. Patients will be approached in the orthopedic clinic up to the day of surgery and asked if they are willing to be screened for inclusion. If they accept the screening request a link will be emailed to them or a QR code supplied that permits them to download the study app on their phone. Screening, consent, and all study data collection will occur from the app launch. All data will be collected after enrollment and consent through the Medable Research Application.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10000}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-01-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2026-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-24', 'studyFirstSubmitDate': '2019-02-06', 'studyFirstSubmitQcDate': '2019-02-06', 'lastUpdatePostDateStruct': {'date': '2025-06-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-02-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reported Pain of Participants measured via PROMIS-29', 'timeFrame': '6 Months', 'description': '28 Questions regarding pain are ranked on a 5-point Likert Scale with 1 meaning "not at all" and 5 meaning "very much".'}, {'measure': 'Reported Pain of Participants measured via PROMIS-29', 'timeFrame': '6 Months', 'description': 'One question on an 11-point rating scale for pain intensity, with 0 meaning "no pain" and 10 meaning "worst imaginable pain".'}, {'measure': 'Reported Pain of Participants measured via Pain Catastrophizing pain scale.', 'timeFrame': '6 Months', 'description': 'Statements regarding pain are rated on a scale from 0 to 4 with 0 meaning "not at all" and 4 meaning "all the time"'}, {'measure': 'Opioid Use of Participants', 'timeFrame': '6 months', 'description': 'Total number of patients with self reported use of opioids.'}, {'measure': 'Practicality of Mobile Application', 'timeFrame': '6 Months', 'description': 'How long participants actively use the app to track their opined use and pain.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['opioid use', 'pain', 'surgery', 'orthopedic surgery', 'orthopedic'], 'conditions': ['Surgery']}, 'descriptionModule': {'briefSummary': "The primary aim of this study is to measure pain and psychosocial patient reported outcomes, objective functionality, and actual daily at home opioid usage in orthopedic patients. The study's goal following the data collection is to predict which patients are at high risk for chronic opioid use."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* aged 18-90 years old who are undergoing elective orthopedic surgery at Duke Health.\n* Patients must have their own smartphone IOS or Android device.\n* Patients must be able to read English.\n\nExclusion Criteria:\n\n* Lacking capacity to provide consent.\n* Cannot read English\n* Under 18 years of age\n* Older than 90 years of age'}, 'identificationModule': {'nctId': 'NCT03834818', 'acronym': 'COMPAS', 'briefTitle': 'Collecting Outcomes and Managing Pain After Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Duke University'}, 'officialTitle': 'COMPAS Trial. Collecting Outcomes and Managing Pain After Surgery: Predicting Patients at High Risk for Chronic Opioid Use and Creating Algorithms to Responsibly Tailor Opioid Prescribing and Weaning After Surgery', 'orgStudyIdInfo': {'id': 'Pro00094157'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'COMPAS Participants', 'description': 'Patents between the ages of 18 and 90 who are undergoing orthopedic surgery at Duke Health will be eligible for enrollment.', 'interventionNames': ['Behavioral: COMPAS Participants']}], 'interventions': [{'name': 'COMPAS Participants', 'type': 'BEHAVIORAL', 'description': 'The schedule of events for this study are as follows:\n\nDay 1 Pre-Surgery:\n\n* Download the Medable App\n* Register to the study\n* Validated Questionnaires\n* Active Task\n\nEvery Day\n\n* 9:00 a.m. Daily Questions\n* 9:00 p.m. Daily Questions\n\nOutcome Surveys and Active Task:\n\n* Day 1 Pre-Surgery\n* 1-Week Post Operation\n* 2-Weeks Post Operation\n* 1-Month Post Operation\n* 3-Months Post Operation\n* 6-Months Post Operation', 'armGroupLabels': ['COMPAS Participants']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Neil D Ray, MD', 'role': 'CONTACT', 'email': 'neil.d.ray@duke.edu', 'phone': '919-681-1924'}], 'facility': 'Duke Orthopaedics', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}], 'centralContacts': [{'name': 'Ashley Burke', 'role': 'CONTACT', 'email': 'ashley.burke@duke.edu', 'phone': '+1 919 681 2849'}, {'name': 'Michael Bullock, MD', 'role': 'CONTACT', 'email': 'william.bullock@duke.edu', 'phone': '+1 919 668 2024'}], 'overallOfficials': [{'name': 'Michael Bullock, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Duke University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Duke University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}