Ignite Creation Date:
2025-12-24 @ 11:29 PM
Ignite Modification Date:
2026-02-27 @ 4:31 PM
Study NCT ID:
NCT03317756
Status:
COMPLETED
Last Update Posted:
2021-09-02
First Post:
2017-09-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
CONfident Treatment Decisions in Living With Rheumatoid Arthritis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001172', 'term': 'Arthritis, Rheumatoid'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'intervention and control arms'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 208}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-03-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2020-09-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-08-29', 'studyFirstSubmitDate': '2017-09-12', 'studyFirstSubmitQcDate': '2017-10-17', 'lastUpdatePostDateStruct': {'date': '2021-09-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-10-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-09-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Acceptability of the educational interventions', 'timeFrame': 'Follow up Survey #1 (after completion of intervention)', 'description': 'We will ask participants to rate the educational content.'}], 'primaryOutcomes': [{'measure': 'Patient willingness to adopt T2T and the attainment of the T2T goals.', 'timeFrame': 'Follow-up Survey #1 (after completion of the intervention)', 'description': 'Name of Scale: Choice predisposition scale The scale measures the willingness to change medication. The scale is a 11-point likert type scale that is scored from not willing at all (minimum) to extremely willing (maximum) with an unsure option (neutral).\n\nHigher scores (closer to the maximum) indicate a willingness to change medication and desire to further improve their RA disease activity.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Rheumatoid Arthritis']}, 'descriptionModule': {'briefSummary': "Pilot test the novel educational patient-directed intervention to demonstrate the feasibility of the novel educational approaches developed in improving patient's willingness to achieve remission or low disease activity in RA.", 'detailedDescription': "Pilot test the novel educational patient-directed intervention to demonstrate the feasibility of the novel educational approaches developed in improving patient's willingness to achieve remission or low disease activity in RA. Upon agreement to participate, the patient participants will provide information on their treating physician. This information will be used to invite physicians to complete the physician-educational intervention and offered CME credits for completing the activity.\n\nThe investigators will recruit participants from a patient registry (1:1 intervention: control) that meet the eligibility criteria. The recruited patients will complete the educational intervention (if randomized to the intervention arm) and the study outcomes will be collected immediately after the intervention and also after the patients most proximate rheumatologist visit (up to 6-months later)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Have a patient-reported diagnosis of RA\n* Most recent RAPID3 \\> 12 collected in the last 6 months\n* Have not changed RA medication in the last 6 months\n* Taking medications that are commonly used in RA (e.g. methotrexate, sulfasalazine, hydroxychloroquine (plaquenil), leflunomide (arava), etanercept (enbrel), adalimumab (Humira), tofacitinib (xeljanz), actemra (tocilizumab), sarilumab (Kevzara) , infliximab (remicade), golimumab (Simponi), rituximab (rituxan), abatacept (Orencia), and certolizumab (Cimzia))\n\nExclusion Criteria:\n\n* Does not meet inclusion criteria\n* Age \\< 18'}, 'identificationModule': {'nctId': 'NCT03317756', 'acronym': 'CONTROL-RA', 'briefTitle': 'CONfident Treatment Decisions in Living With Rheumatoid Arthritis', 'organization': {'class': 'OTHER', 'fullName': 'University of Alabama at Birmingham'}, 'officialTitle': 'CONfident Treatment Decisions in Living With Rheumatoid Arthritis', 'orgStudyIdInfo': {'id': 'X151222003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Patient Variation 1', 'description': 'Patient Educational Intervention: Patient will receive intervention videos and will be required to complete the baseline and follow-up surveys.', 'interventionNames': ['Other: Patient Educational Intervention']}, {'type': 'EXPERIMENTAL', 'label': 'Patient Variation 2', 'description': 'Patient Control: Patients will receive an attention control and will be required to complete the baseline and follow-up surveys.', 'interventionNames': ['Other: Patient Control']}], 'interventions': [{'name': 'Patient Educational Intervention', 'type': 'OTHER', 'description': 'Patients will view 5-6 videos that will help them with pre-identified patient barriers to achieving RA low disease activity', 'armGroupLabels': ['Patient Variation 1']}, {'name': 'Patient Control', 'type': 'OTHER', 'description': 'Patients will receive an attention control', 'armGroupLabels': ['Patient Variation 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35294', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama at Birmingham', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}], 'overallOfficials': [{'name': 'Maria I Danila, MD MSc MSPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Alabama at Birmingham'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'No individual data. Aggregate results will be reported.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Alabama at Birmingham', 'class': 'OTHER'}, 'collaborators': [{'name': 'Pfizer Independent Grants for Learning and Change', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Maria Danila, MD, MSc, MSPH', 'investigatorAffiliation': 'University of Alabama at Birmingham'}}}}