Ignite Creation Date:
2025-12-25 @ 3:15 AM
Ignite Modification Date:
2026-03-03 @ 4:15 AM
Study NCT ID:
NCT02416505
Status:
COMPLETED
Last Update Posted:
2016-10-04
First Post:
2015-04-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Age of OrthoInfo: A Randomized Controlled Trial Evaluating Patient Comprehension of Informed Consent
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020370', 'term': 'Osteoarthritis, Knee'}], 'ancestors': [{'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 67}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'lastUpdateSubmitDate': '2016-10-02', 'studyFirstSubmitDate': '2015-04-06', 'studyFirstSubmitQcDate': '2015-04-09', 'lastUpdatePostDateStruct': {'date': '2016-10-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-04-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Nkem Test', 'timeFrame': '20 minutes', 'description': 'Comprehension based examination of an informed consent discussion'}], 'secondaryOutcomes': [{'measure': 'Patient Satisfaction Survey', 'timeFrame': '5 minutes'}]}, 'conditionsModule': {'conditions': ['Knee Osteoarthritis']}, 'descriptionModule': {'briefSummary': 'This study is a Non-funded, Single Center, Multi-Arm, Parallel Group Randomize Control Trial.\n\nIn this study, the investigators aim to evaluate the impact of a visual aid on patient comprehension an orthopedic informed consent discussion in low socioeconomic populations.\n\nThe primary outcome is patient comprehension measured by a Validated Knowledge-Based Multiple Choice Questionnaire.\n\nThe secondary outcomes include: Patient satisfaction and Time efficiency.\n\nThe investigators hypothesize that using an Anatomic Model Visual Aid during an orthopedic informed consent discussion will improve patient comprehension, satisfaction and time-efficiency of orthopedic care.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients newly diagnosed with Knee Osteoarthritis managed with steroid injections\n* Patients who express lack of knowledge regarding knee osteoarthritis (causes, diagnosis, treatment, anatomy)\n* English speaking\n* Patients that meet the Federal Poverty Guideline for Healthcare (i.e. Medicaid)\n\nExclusion Criteria:\n\n* Patients under the age of 18\n* College graduates\n* Non-English speaking\n* Patient without the capacity to give consent\n* Patients with a tactile, mental, visual or auditory disability'}, 'identificationModule': {'nctId': 'NCT02416505', 'briefTitle': 'The Age of OrthoInfo: A Randomized Controlled Trial Evaluating Patient Comprehension of Informed Consent', 'organization': {'class': 'OTHER', 'fullName': 'University of Missouri, Kansas City'}, 'orgStudyIdInfo': {'id': '14-334'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Verbal Discussion: Control Group', 'description': 'In this group, participants will receive a 10 minute Verbal Only Knee Osteoarthritis Steroid Injection Informed Consent discussion.\n\nThis discussion will cover the relevant topics of Knee OA causes, relevant anatomy, symptoms, diagnosis, and treatment options. This discussion will also include the risks, benefits, and alternatives to a steroid injection.'}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Verbal+Anatomic Model', 'description': 'This intervention group will receive a 10 minute Knee Osteoarthritis Steroid Injection Informed Consent discussion with the aid of a Knee Model.\n\nThis discussion will cover the relevant topics of Knee OA causes, relevant anatomy, symptoms, diagnosis, and treatment options. This discussion will also include the risks, benefits, and alternatives to a steroid injection.', 'interventionNames': ['Behavioral: Verbal+Anatomic Model']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Verbal+Video Presentation', 'description': 'This intervention group will receive a 10 minute Knee Osteoarthritis Steroid Injection Informed Consent discussion with the aid of a Video.\n\nThis discussion will cover the relevant topics of Knee OA causes, relevant anatomy, symptoms, diagnosis, and treatment options. This discussion will also include the risks, benefits, and alternatives to a steroid injection.', 'interventionNames': ['Behavioral: Verbal+Video']}], 'interventions': [{'name': 'Verbal+Anatomic Model', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Verbal+Anatomic Model']}, {'name': 'Verbal+Video', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Verbal+Video Presentation']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Mark Bernhardt, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'UMKC Department of Orthopaedic Surgery'}, {'name': 'Johnathan Dubin, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'UMKC Department of Orthopaedic Surgery'}, {'name': 'Karen Williams, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'UMKC Dept of Bioinformatics'}, {'name': 'Nkem Egekeze, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UMKC Dept of Orthopaedic Surgery'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Missouri, Kansas City', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Orthopedic Surgery Researcher', 'investigatorFullName': 'Nkemakolam Egekeze', 'investigatorAffiliation': 'University of Missouri, Kansas City'}}}}