Ignite Creation Date:
2025-12-24 @ 4:45 PM
Ignite Modification Date:
2025-12-25 @ 2:32 PM
Study NCT ID:
NCT06018350
Status:
COMPLETED
Last Update Posted:
2025-09-09
First Post:
2023-08-25
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Medication Adherence in Rheumatic Diseases
Sponsor:
Organization:
Raw JSON
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{'value': '1', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '57', 'groupId': 'BG001'}, {'value': '62', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'BG000'}, {'value': '96', 'groupId': 'BG001'}, {'value': '102', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '96', 'groupId': 'BG001'}, {'value': '102', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-06-06', 'size': 268201, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-04-17T14:39', 'hasProtocol': True}, {'date': '2023-11-15', 'size': 146854, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2024-09-06T15:41', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 102}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-02-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2024-06-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-19', 'studyFirstSubmitDate': '2023-08-25', 'resultsFirstSubmitDate': '2025-04-17', 'studyFirstSubmitQcDate': '2023-08-25', 'lastUpdatePostDateStruct': {'date': '2025-09-09', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-08-19', 'studyFirstPostDateStruct': {'date': '2023-08-30', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-09-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-06-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change in MPR (Medication Possession Ratio) as a Percentage', 'timeFrame': 'Baseline to 6 months', 'description': 'MPR is calculated by dividing the number of days a patient is covered by medication by the total number of days in the observation period. This is multiplied by 100 to present a percent change.'}], 'primaryOutcomes': [{'measure': 'Intervention Feasibility as Measured by Number of Providers Agreeing to Participate', 'timeFrame': '4 weeks'}, {'measure': 'Intervention Feasibility as Measured by the Feasibility of Intervention Measure (FIM)', 'timeFrame': '4 weeks', 'description': 'Provider survey based on the Feasibility of Intervention Measure, scores range from 1-5, where 5 is most feasible.'}, {'measure': 'Intervention Feasibility as Measured by Percent of Visits With EMR Documentation of Providers Reviewing Refills', 'timeFrame': '4 weeks', 'description': 'Calculated for the full population, not per participant.'}], 'secondaryOutcomes': [{'measure': 'Intervention Acceptability as Measured by the Acceptability of Intervention Measure (AIM)', 'timeFrame': '4 weeks', 'description': 'Provider survey based on the Acceptability of Intervention Measure, scores range from 1-5, where 5 is most acceptable.'}, {'measure': 'Intervention Acceptability as Measured by the Percentage of Patients Who Report a Positive Feeling After Having an Adherence Conversation With Their Providers', 'timeFrame': '4 weeks', 'description': 'Patient survey will be administered following provider visit.'}, {'measure': 'Fidelity as Measured by the Number of Participants With Clinicians Conducting the Intervention Components of Reviewing Pharmacy Refills and Using Effective Communication Strategies', 'timeFrame': '4 weeks', 'description': 'This was collected using a EMR Smartphrase where clinicians documented whether they reviewed pharmacy refill data or discussed adherence with patients.'}, {'measure': 'Fidelity as Measured by the Number of Participants With EMR Documentation of Completing the Intervention Components of Reviewing Pharmacy Refills and Using Effective Communication Strategies', 'timeFrame': '4 weeks'}, {'measure': 'Change in MPR (Medication Possession Ratio) as a Percentage for the Entire Sample', 'timeFrame': 'Baseline to 3 months', 'description': 'MPR is calculated by dividing the number of days all patients were covered by medication by the total number of days in the observation period. This is multiplied by 100 to present a percent change for the entire sample.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Chronic Rheumatic Diseases']}, 'descriptionModule': {'briefSummary': 'The investigators will pilot test a clinician-led intervention to improve medication adherence in general rheumatology clinic across a spectrum of rheumatic diseases. The study will assess feasibility, acceptability, and fidelity, and explore signal for improved medication adherence.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* all providers at Southpoint Rheumatology All patients with a rheumatic disease diagnosis currently prescribed at least one rheumatic medication will be included in the analysis\n\nExclusion Criteria:\n\n* new patients, those who are not prescribed any rheumatic disease medications, or do not have available pharmacy refill data'}, 'identificationModule': {'nctId': 'NCT06018350', 'briefTitle': 'Medication Adherence in Rheumatic Diseases', 'organization': {'class': 'OTHER', 'fullName': 'Duke University'}, 'officialTitle': 'Improving Medication Adherence in Chronic Rheumatic Diseases', 'orgStudyIdInfo': {'id': 'Pro00108618'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'Clinicians in this arm will be trained to conduct the adherence intervention in general rheumatology clinic with all follow up patients with a chronic rheumatic disease.\n\nPatients seen by these clinicians will contribute to the outcome data collection.', 'interventionNames': ['Behavioral: Clinician-led adherence intervention']}], 'interventions': [{'name': 'Clinician-led adherence intervention', 'type': 'BEHAVIORAL', 'description': 'The clinician will review real time pharmacy refill data during clinic and use effective communication techniques to discuss adherence with the patient', 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}], 'overallOfficials': [{'name': 'Kai Sun, MD, MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Duke Health'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Duke University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}