Ignite Creation Date:
2025-12-25 @ 12:04 AM
Ignite Modification Date:
2025-12-25 @ 10:02 PM
Study NCT ID:
NCT05811858
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-04-13
First Post:
2023-03-31
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Investigating Medical Research Trends in Osteoarthritis Clinical Trials
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010003', 'term': 'Osteoarthritis'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-03-30', 'size': 73587, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2023-03-31T00:52', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-04', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2026-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-03-31', 'studyFirstSubmitDate': '2023-03-31', 'studyFirstSubmitQcDate': '2023-03-31', 'lastUpdatePostDateStruct': {'date': '2023-04-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-04-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of patients who decide to enroll in an osteoarthritis clinical study.', 'timeFrame': '3 months'}, {'measure': 'Number of osteoarthritis patients who remain in clinical trial until completion.', 'timeFrame': '12 months'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['osteoarthritis'], 'conditions': ['Osteoarthritis']}, 'referencesModule': {'references': [{'pmid': '35487477', 'type': 'BACKGROUND', 'citation': 'Stabile M, Van Ryssen B, Minei S, Coppieters E, Crovace A, Lacitignola L, Staffieri F. Observational study of the clinical value of the canine osteoarthritis staging tool. Vet J. 2022 May-Jun;283-284:105832. doi: 10.1016/j.tvjl.2022.105832. Epub 2022 Apr 27.'}, {'pmid': '35676666', 'type': 'BACKGROUND', 'citation': 'Akesson KS, Sunden A, Stigmar K, Fagerstrom C, Pawlikowska T, Ekvall Hansson E. Enablement and empowerment among patients participating in a supported osteoarthritis self-management programme - a prospective observational study. BMC Musculoskelet Disord. 2022 Jun 8;23(1):555. doi: 10.1186/s12891-022-05457-9.'}, {'pmid': '33797056', 'type': 'BACKGROUND', 'citation': 'Ellis KR, Cuthbertson CC, Carthron D, Rimmler S, Gottfredson NC, Bahorski SG, Phillips A, Corbie-Smith G, Callahan L, Rini C. A Longitudinal Observational Study of Multimorbidity and Partner Support for Physical Activity Among People with Osteoarthritis. Int J Behav Med. 2021 Dec;28(6):746-758. doi: 10.1007/s12529-021-09985-x. Epub 2021 Apr 2.'}]}, 'descriptionModule': {'briefSummary': "Clinical research participation percentages haven't always been fully representative of a given demographic.\n\nThe goal is to find out which aspects of a clinical trial may make it more difficult for patients to take part or see it through.\n\nThe data will be evaluated through different demographic lenses and identify trends that could help improve the experience of future osteoarthritis patients during clinical study."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with osteoarthritis who are actively considering involvement in an observational clinical trial, but have not yet completed enrollment and registration.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Aged ≥ 18 years old and ability to provide written informed consent obtained prior to participation in the study and any related procedures being performed.\n* Participant has a diagnosis of osteoarthritis.\n* Willing and able to comply with scheduled visits, treatment schedule, laboratory tests and other requirements of the study.\n\nExclusion Criteria:\n\n* Patients with any significant history of non-compliance to medical regimens or with inability to grant a reliable informed consent.\n* Pregnant or lactating woman\n* Known medical condition that, in the investigator's opinion, would increase the risk associated with study participation or study drug(s) administration or interfere with the interpretation of safety results"}, 'identificationModule': {'nctId': 'NCT05811858', 'briefTitle': 'Investigating Medical Research Trends in Osteoarthritis Clinical Trials', 'organization': {'class': 'INDUSTRY', 'fullName': 'Power Life Sciences Inc.'}, 'officialTitle': 'Analyzing Factors Impacting Patient Involvement in Osteoarthritis Clinical Research', 'orgStudyIdInfo': {'id': '84129695'}}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Michael B Gill', 'role': 'CONTACT', 'email': 'bask@withpower.com', 'phone': '415-900-4227'}], 'overallOfficials': [{'name': 'Michael B Gill', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Power Life Sciences Inc.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Power Life Sciences Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}