Nctid:
NCT06232603
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-04"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000010019", "term"=>"Osteomyelitis"}, {"id"=>"D000012008", "term"=>"Recurrence"}], "ancestors"=>[{"id"=>"D000020969", "term"=>"Disease Attributes"}, {"id"=>"D000010335", "term"=>"Pathologic Processes"}, {"id"=>"D000001850", "term"=>"Bone Diseases, Infectious"}, {"id"=>"D000007239", "term"=>"Infections"}, {"id"=>"D000001847", "term"=>"Bone Diseases"}, {"id"=>"D000009140", "term"=>"Musculoskeletal Diseases"}], "browseLeaves"=>[{"id"=>"M12942", "name"=>"Osteomyelitis", "asFound"=>"Osteomyelitis", "relevance"=>"HIGH"}, {"id"=>"M14850", "name"=>"Recurrence", "asFound"=>"Recurrent", "relevance"=>"HIGH"}, {"id"=>"M22700", "name"=>"Disease Attributes", "relevance"=>"LOW"}, {"id"=>"M10283", "name"=>"Infections", "relevance"=>"LOW"}, {"id"=>"M6368", "name"=>"Communicable Diseases", "relevance"=>"LOW"}, {"id"=>"M5126", "name"=>"Bone Diseases", "relevance"=>"LOW"}, {"id"=>"M5129", "name"=>"Bone Diseases, Infectious", "relevance"=>"LOW"}, {"id"=>"M12097", "name"=>"Musculoskeletal Diseases", "relevance"=>"LOW"}, {"id"=>"T4321", "name"=>"Osteomyelitis", "asFound"=>"Osteomyelitis", "relevance"=>"HIGH"}, {"id"=>"T1303", "name"=>"Chronic Graft Versus Host Disease", "relevance"=>"LOW"}, {"id"=>"T1315", "name"=>"Chronic Recurrent Multifocal Osteomyelitis", "asFound"=>"Chronic Recurrent Multifocal Osteomyelitis", "relevance"=>"HIGH"}], "browseBranches"=>[{"name"=>"Infections", "abbrev"=>"BC01"}, {"name"=>"Musculoskeletal Diseases", "abbrev"=>"BC05"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"Rare Diseases", "abbrev"=>"Rare"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["NA"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"RANDOMIZED", "maskingInfo"=>{"masking"=>"NONE"}, "primaryPurpose"=>"OTHER", "interventionModel"=>"PARALLEL"}, "enrollmentInfo"=>{"type"=>"ACTUAL", "count"=>9}}, "statusModule"=>{"whyStopped"=>"lack of staffing and funding support", "overallStatus"=>"TERMINATED", "startDateStruct"=>{"date"=>"2024-02-20", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-07", "completionDateStruct"=>{"date"=>"2024-06-18", "type"=>"ACTUAL"}, "lastUpdateSubmitDate"=>"2024-07-26", "studyFirstSubmitDate"=>"2023-10-23", "studyFirstSubmitQcDate"=>"2024-01-28", "lastUpdatePostDateStruct"=>{"date"=>"2024-07-29", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-01-31", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2024-06-18", "type"=>"ACTUAL"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Medication possession ratio (MPR)", "timeFrame"=>"6 to 9 months", "description"=>"The MPR is reported as a percentage calculated as: (total prescription days of supply/ (last prescription date - the first prescription date)). For example, if a patient only filled a one-month prescription twice during 6 months, so only had 60 days of medications available during the 6 months, the MPR would be 33%. A MPR of ≥0.8 is generally accepted as good compliance.\n\nThe MPR data will be calculated for T0 and T1. In order to capture adequate data to calculate the MPR, refill data was acquired for 3 months prior to the beginning of the study (MPR T0) and for 3 months after T1 (MPR T1)."}], "secondaryOutcomes"=>[{"measure"=>"Barriers to adherence", "timeFrame"=>"6-9 months", "description"=>"A survey will be conducted to determine the barriers predefined and any other barriers"}]}, "oversightModule"=>{"oversightHasDmc"=>false, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"conditions"=>["Chronic Recurrent Multifocal Osteomyelitis"]}, "referencesModule"=>{"references"=>[{"pmid"=>"35938626", "type"=>"BACKGROUND", "citation"=>"Semo-Oz R, Wagner-Weiner L, Edens C, Zic C, One K, Saad N, Tesher M. Adherence to medication by adolescents and young adults with childhood-onset systemic lupus erythematosus. Lupus. 2022 Oct;31(12):1508-1515. doi: 10.1177/09612033221115974. Epub 2022 Aug 7."}, {"pmid"=>"32183424", "type"=>"BACKGROUND", "citation"=>"Verma T, Rohan J. Examination of Transition Readiness, Medication Adherence, and Resilience in Pediatric Chronic Illness Populations: A Pilot Study. Int J Environ Res Public Health. 2020 Mar 15;17(6):1905. doi: 10.3390/ijerph17061905."}, {"pmid"=>"29204970", "type"=>"BACKGROUND", "citation"=>"Saag KG, Bhatia S, Mugavero MJ, Singh JA. Taking an Interdisciplinary Approach to Understanding and Improving Medication Adherence. J Gen Intern Med. 2018 Feb;33(2):136-138. doi: 10.1007/s11606-017-4215-7. No abstract available."}, {"pmid"=>"24504596", "type"=>"BACKGROUND", "citation"=>"Len CA, Miotto e Silva VB, Terreri MT. Importance of adherence in the outcome of juvenile idiopathic arthritis. Curr Rheumatol Rep. 2014 Apr;16(4):410. doi: 10.1007/s11926-014-0410-2."}, {"pmid"=>"29419467", "type"=>"BACKGROUND", "citation"=>"Favier LA, Taylor J, Loiselle Rich K, Jones KB, Vora SS, Harris JG, Gottlieb BS, Robbins L, Lai JT, Lee T, Kohlheim M, Gill J, Bouslaugh L, Young A, Griffin N, Morgan EM, Modi AC. Barriers to Adherence in Juvenile Idiopathic Arthritis: A Multicenter Collaborative Experience and Preliminary Results. J Rheumatol. 2018 May;45(5):690-696. doi: 10.3899/jrheum.171087. Epub 2018 Feb 1."}]}, "descriptionModule"=>{"briefSummary"=>"This project aims to quantify and evaluate rates of non-adherence and barriers to medication adherence in pediatric patients with CRMO followed at Seattle Children's Hospital's robust CRMO program, which is the only clinical program in the Washington, Wyoming, Alaska, Montana, Idaho (WWAMI) region. This will be a stepped-wedge cluster-randomized trial, in which participants will be randomly assigned to one of two groups -- one which receives educational materials at the end of their first clinic visit, and the other which receives educational materials at the end of their second clinic visit. All participants will be given baseline surveys at the start of their first clinic visit, as well as follow-up surveys at the start of their second and third clinic visits. These surveys aim to evaluate rates of non-adherence and qualitative barriers to adherence, as well as efficacy of educational interventions in improving adherence rates."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["CHILD", "ADULT"], "maximumAge"=>"21 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* Diagnosis of CRMO\n* Receives clinical care at Seattle Children's Hospital\n* On one or more scheduled prescription medications\n\nExclusion Criteria:\n\n-"}, "identificationModule"=>{"nctId"=>"NCT06232603", "briefTitle"=>"Medication Adherence Intervention in Chronic Recurrent Multifocal Osteomyelitis (CRMO)", "organization"=>{"class"=>"OTHER", "fullName"=>"Seattle Children's Hospital"}, "officialTitle"=>"Assessing Medication Adherence in Patients With Chronic Recurrent Multifocal Osteomyelitis", "orgStudyIdInfo"=>{"id"=>"STUDY00004426"}}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"ACTIVE_COMPARATOR", "label"=>"Education at baseline", "description"=>"video and ambulatory visit summary (AVS) education will be provided at baseline visit", "interventionNames"=>["Other: Education of medication management"]}, {"type"=>"OTHER", "label"=>"Education at the first follow up", "description"=>"video and AVS education will be provided at the first follow up visit", "interventionNames"=>["Other: Education of medication management"]}], "interventions"=>[{"name"=>"Education of medication management", "type"=>"OTHER", "description"=>"Video and handout materials will be provided", "armGroupLabels"=>["Education at baseline", "Education at the first follow up"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"98105", "city"=>"Seattle", "state"=>"Washington", "country"=>"United States", "facility"=>"Seattle Children's Hospital", "geoPoint"=>{"lat"=>47.60621, "lon"=>-122.33207}}]}, "ipdSharingStatementModule"=>{"ipdSharing"=>"NO"}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Seattle Children's Hospital", "class"=>"OTHER"}, "collaborators"=>[{"name"=>"University of Washington", "class"=>"OTHER"}], "responsibleParty"=>{"type"=>"PRINCIPAL_INVESTIGATOR", "investigatorTitle"=>"Associate professor, attending physician", "investigatorFullName"=>"Yongdong (Dan) Zhao", "investigatorAffiliation"=>"Seattle Children's Hospital"}}}}
