Nctid:
NCT06233760
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-12-20"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D012216", "term"=>"Rheumatic Diseases"}, {"id"=>"D003095", "term"=>"Collagen Diseases"}], "ancestors"=>[{"id"=>"D009140", "term"=>"Musculoskeletal Diseases"}, {"id"=>"D003240", "term"=>"Connective Tissue Diseases"}], "browseLeaves"=>[{"id"=>"M15045", "name"=>"Rheumatic Diseases", "asFound"=>"Rheumatic Diseases", "relevance"=>"HIGH"}, {"id"=>"M6323", "name"=>"Collagen Diseases", "asFound"=>"Rheumatic Diseases", "relevance"=>"HIGH"}, {"id"=>"M12097", "name"=>"Musculoskeletal Diseases", "relevance"=>"LOW"}, {"id"=>"M6464", "name"=>"Connective Tissue Diseases", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Musculoskeletal Diseases", "abbrev"=>"BC05"}, {"name"=>"Skin and Connective Tissue Diseases", "abbrev"=>"BC17"}, {"name"=>"All Conditions", "abbrev"=>"All"}]}}, "protocolSection"=>{"designModule"=>{"studyType"=>"OBSERVATIONAL", "designInfo"=>{"timePerspective"=>"CROSS_SECTIONAL", "observationalModel"=>"CASE_CROSSOVER"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>244}, "patientRegistry"=>false}, "statusModule"=>{"overallStatus"=>"RECRUITING", "startDateStruct"=>{"date"=>"2023-04-01", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-03", "completionDateStruct"=>{"date"=>"2026-03-02", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-03-09", "studyFirstSubmitDate"=>"2024-01-14", "studyFirstSubmitQcDate"=>"2024-01-22", "lastUpdatePostDateStruct"=>{"date"=>"2024-03-12", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-01-31", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2025-02-01", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Number of Mexican patients with RD who will present the phenomenon of mistreatment", "timeFrame"=>"At inclusion (baseline moment) (cross-sectional study)", "description"=>"Identify the percentage of patients with rheumatic diseases that present mistreatment using the instrument developed by Giraldo-Rodríguez et al (translation, cultural adaptation, and validation performed)"}], "secondaryOutcomes"=>[{"measure"=>"Identify factors associated with mistreatment among patients with rheumatic diseases", "timeFrame"=>"At inclusion (baseline moment) (cross-sectional study)", "description"=>"Identify factors associated with mistreatment among patients with rheumatic diseases using an instrument locally development"}]}, "oversightModule"=>{"oversightHasDmc"=>false, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"keywords"=>["rheumatic diseases", "Abuse"], "conditions"=>["Rheumatic Diseases", "Abuse Neglect", "Abuse"]}, "referencesModule"=>{"references"=>[{"pmid"=>"22694594", "type"=>"BACKGROUND", "citation"=>"Giraldo-Rodriguez L, Rosas-Carrasco O. Development and psychometric properties of the Geriatric Mistreatment Scale. Geriatr Gerontol Int. 2013 Apr;13(2):466-74. doi: 10.1111/j.1447-0594.2012.00894.x. Epub 2012 Jun 14."}, {"pmid"=>"16357732", "type"=>"BACKGROUND", "citation"=>"Castro I, Barrantes F, Tuna M, Cabrera G, Garcia C, Recinos M, Espinoza LR, Garcia-Kutzbach A. Prevalence of abuse in fibromyalgia and other rheumatic disorders at a specialized clinic in rheumatic diseases in Guatemala City. J Clin Rheumatol. 2005 Jun;11(3):140-5. doi: 10.1097/01.rhu.0000164823.78761.a2."}]}, "descriptionModule"=>{"briefSummary"=>"Patients with rheumatic diseases (RD) have a relevant representation in the adult population in Mexico. RD are characterized by their chronic and progressive nature, which can impact functionality during the disease and can present various factors that can be associated with the presence of abuse, among others, economic dependence, decreased physical capacity, and need for care and support in different health processes.\n\nRegarding abuse in patients with RD, there is little information in the literature; however, it is possible that the prevalence could be similar to that of the occurrence in older adults since both populations share important states of vulnerability.\n\nThe study aimed to identify the prevalence of abuse in patients with RD. The study will be conducted in two phases: the first one in which the GAS will be adapted for patients with RD, and this version will be validated in a population of our Institute, and the second one in which, applying the validated instrument, the magnitude of abuse is evaluated, and the factors associated with this phenomenon among patients with RD are explored.", "detailedDescription"=>"Patients with rheumatic diseases (RD) have a relevant representation in the adult population in Mexico. RD are characterized by their chronic and progressive nature, which can impact functionality during the disease and can present various factors that can be associated with the presence of abuse, among others, economic dependence, decreased physical capacity, and need for care and support in different health processes.\n\nIn 1970, the phenomenon of abuse in geriatric patients was described for the first time as a phenomenon identified as a public health problem and an issue of human rights violation.\n\nIn 2012 Giraldo-Rodríguez developed and validated the Geriatric Abuse Scale (GAS), an instrument that, with adequate psychometric properties, reported a prevalence of abuse of 10.28% in Mexico.\n\nRegarding abuse in patients with RD, there is little information in the literature; however, it is possible that the prevalence could be similar to that of the occurrence in older adults since both populations share important states of vulnerability.\n\nThe study aimed to identify the prevalence of abuse in patients with RD. The study will be conducted in two phases: the first one in which the GAS will be adapted for patients with RD, and this version will be validated in a population of our Institute, and the second one in which, applying the validated instrument, the magnitude of abuse is evaluated, and the factors associated with this phenomenon among patients with RD are explored."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "maximumAge"=>"100 years", "minimumAge"=>"18 years", "samplingMethod"=>"PROBABILITY_SAMPLE", "studyPopulation"=>"All the rheumatic diseases outpatients from the National Institute of Medical Sciences", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* Patients with a rheumatic disease diagnosis according to their primary rheumatologist who agree to participate\n\nExclusion Criteria:\n\n* Patients with a not confirmed rheumatic disease"}, "identificationModule"=>{"nctId"=>"NCT06233760", "briefTitle"=>"Prevalence of Abuse Among Patients With Rheumatic Diseases", "organization"=>{"class"=>"OTHER", "fullName"=>"National Institute of Medical Sciences and Nutrition, Salvador Zubiran"}, "officialTitle"=>"Prevalence of Abuse Among Patients With Rheumatic Diseases", "orgStudyIdInfo"=>{"id"=>"IRE3234"}}, "armsInterventionsModule"=>{"armGroups"=>[{"label"=>"Patients with rheumatic diseases", "description"=>"All the rheumatic diseases outpatients from the National Institute of Medical Sciences", "interventionNames"=>["Other: Rheumatic diseases Mistreatment Scale (RDMS)", "Other: Health Assessment Questionnaire (HAQ)", "Other: Depression, Anxiety and Stress Scale (DASS-21)", "Other: Brief Resilient Coping Scale", "Other: WHOQOL-BREF", "Other: Routine assessment of patient index data 3 (RAPID-3)", "Other: Big Five Inventory", "Other: Family APGAR Questionnaire"]}], "interventions"=>[{"name"=>"Rheumatic diseases Mistreatment Scale (RDMS)", "type"=>"OTHER", "otherNames"=>["RD-MS"], "description"=>"In 2012 Giraldo-Rodríguez developed and validated the Geriatric Mistreatment Scale (GAS), prior to its application, translation, cultural adaptation, and validation were performed.", "armGroupLabels"=>["Patients with rheumatic diseases"]}, {"name"=>"Health Assessment Questionnaire (HAQ)", "type"=>"OTHER", "otherNames"=>["HAQ"], "description"=>"The HAQ is based on five patient-centered dimensions: disability, pain, medication effects, costs of care, and mortality", "armGroupLabels"=>["Patients with rheumatic diseases"]}, {"name"=>"Depression, Anxiety and Stress Scale (DASS-21)", "type"=>"OTHER", "otherNames"=>["DASS-21"], "description"=>"DASS-21 is a set of three self-report scales designed to measure the emotional states of depression, anxiety, and stress. Each of the three DASS-21 scales contains 7 items, divided into subscales with similar content", "armGroupLabels"=>["Patients with rheumatic diseases"]}, {"name"=>"Brief Resilient Coping Scale", "type"=>"OTHER", "otherNames"=>["BRCS"], "description"=>"Brief Resilient Coping Scale is a 4-item measure designed to capture tendencies to cope with stress in a highly adaptive manner", "armGroupLabels"=>["Patients with rheumatic diseases"]}, {"name"=>"WHOQOL-BREF", "type"=>"OTHER", "description"=>"WHOQOL-BREF is a 26-item instrument consisting of four domains: physical health, psychological health, social relationships, and environmental health; it also contains QOL and general health items", "armGroupLabels"=>["Patients with rheumatic diseases"]}, {"name"=>"Routine assessment of patient index data 3 (RAPID-3)", "type"=>"OTHER", "otherNames"=>["RAPID-3"], "description"=>"RAPID- 3 measures: function, pain, and patient global estimate of status. Each of the 3 individual measures is scored 0 to 10, for a total of 30", "armGroupLabels"=>["Patients with rheumatic diseases"]}, {"name"=>"Big Five Inventory", "type"=>"OTHER", "otherNames"=>["BFI-10"], "description"=>"The BFI-10 is a 10-item scale measuring the Big Five personality traits Extraversion, Agreeableness, Conscientiousness, Emotional Stability, and Openness.", "armGroupLabels"=>["Patients with rheumatic diseases"]}, {"name"=>"Family APGAR Questionnaire", "type"=>"OTHER", "otherNames"=>["APGAR"], "description"=>"Family APGAR questionnaire is used to evaluate family function, in the context of family medical care", "armGroupLabels"=>["Patients with rheumatic diseases"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"14080", "city"=>"Mexico City", "status"=>"RECRUITING", "country"=>"Mexico", "contacts"=>[{"name"=>"Virginia Pascual-Ramos, MD", "role"=>"CONTACT", "email"=>"virtichu@gmail.com", "phone"=>"00525555734111", "phoneExt"=>"533"}], "facility"=>"Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán", "geoPoint"=>{"lat"=>19.42847, "lon"=>-99.12766}}], "centralContacts"=>[{"name"=>"Virginia Ph Pascual-Ramos", "role"=>"CONTACT", "email"=>"virtichu@gmail.com", "phone"=>"525555734111", "phoneExt"=>"533"}, {"name"=>"Virginia Dr Pascual-Ramos", "role"=>"CONTACT", "email"=>"virtichu@gmail.com", "phone"=>"525555734111", "phoneExt"=>"533"}], "overallOfficials"=>[{"name"=>"Virginia Dr Pascual-Ramos", "role"=>"PRINCIPAL_INVESTIGATOR", "affiliation"=>"INNSZ"}]}, "ipdSharingStatementModule"=>{"ipdSharing"=>"NO"}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"National Institute of Medical Sciences and Nutrition, Salvador Zubiran", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"PRINCIPAL_INVESTIGATOR", "investigatorTitle"=>"Principal investigator", "investigatorFullName"=>"Virginia Pascual Ramos", "investigatorAffiliation"=>"National Institute of Medical Sciences and Nutrition, Salvador Zubiran"}}}}
