Nctid:
NCT00000396
Payload:
{"FullStudy"=>{"Rank"=>474003, "Study"=>{"DerivedSection"=>{"MiscInfoModule"=>{"VersionHolder"=>"November 27, 2023"}, "ConditionBrowseModule"=>{"ConditionMeshList"=>{"ConditionMesh"=>[{"ConditionMeshId"=>"D000001168", "ConditionMeshTerm"=>"Arthritis"}]}, "ConditionAncestorList"=>{"ConditionAncestor"=>[{"ConditionAncestorId"=>"D000007592", "ConditionAncestorTerm"=>"Joint Diseases"}, {"ConditionAncestorId"=>"D000009140", "ConditionAncestorTerm"=>"Musculoskeletal Diseases"}]}, "ConditionBrowseLeafList"=>{"ConditionBrowseLeaf"=>[{"ConditionBrowseLeafId"=>"M4166", "ConditionBrowseLeafName"=>"Arthritis", "ConditionBrowseLeafAsFound"=>"Arthritis", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"M10311", "ConditionBrowseLeafName"=>"Joint Diseases", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M11787", "ConditionBrowseLeafName"=>"Musculoskeletal Diseases", "ConditionBrowseLeafRelevance"=>"low"}]}, "ConditionBrowseBranchList"=>{"ConditionBrowseBranch"=>[{"ConditionBrowseBranchName"=>"Musculoskeletal Diseases", "ConditionBrowseBranchAbbrev"=>"BC05"}, {"ConditionBrowseBranchName"=>"All Conditions", "ConditionBrowseBranchAbbrev"=>"All"}]}}}, "ProtocolSection"=>{"DesignModule"=>{"PhaseList"=>{"Phase"=>["Not Applicable"]}, "StudyType"=>"Interventional", "DesignInfo"=>{"DesignAllocation"=>"Randomized", "DesignMaskingInfo"=>{"DesignMasking"=>"None (Open Label)"}, "DesignInterventionModel"=>"Single Group Assignment"}, "EnrollmentInfo"=>{"EnrollmentType"=>"Actual", "EnrollmentCount"=>"90"}}, "StatusModule"=>{"OverallStatus"=>"Completed", "StartDateStruct"=>{"StartDate"=>"September 1997"}, "ExpandedAccessInfo"=>{"HasExpandedAccess"=>"No"}, "StatusVerifiedDate"=>"June 2013", "CompletionDateStruct"=>{"CompletionDate"=>"October 2002", "CompletionDateType"=>"Actual"}, "LastUpdateSubmitDate"=>"June 8, 2013", "StudyFirstSubmitDate"=>"November 3, 1999", "StudyFirstSubmitQCDate"=>"November 3, 1999", "LastUpdatePostDateStruct"=>{"LastUpdatePostDate"=>"June 11, 2013", "LastUpdatePostDateType"=>"Estimate"}, "StudyFirstPostDateStruct"=>{"StudyFirstPostDate"=>"November 4, 1999", "StudyFirstPostDateType"=>"Estimate"}, "PrimaryCompletionDateStruct"=>{"PrimaryCompletionDate"=>"March 2001", "PrimaryCompletionDateType"=>"Actual"}}, "OutcomesModule"=>{"PrimaryOutcomeList"=>{"PrimaryOutcome"=>[{"PrimaryOutcomeMeasure"=>"Knowledge of arthritis self-care behaviors", "PrimaryOutcomeTimeFrame"=>"Measured upon completion of the educational intervention and at 6-month follow-up"}]}}, "OversightModule"=>{"OversightHasDMC"=>"No"}, "ConditionsModule"=>{"KeywordList"=>{"Keyword"=>["Arthritis", "Arthritis education", "African Americans", "Self-help", "Self-management", "Cultural beliefs"]}, "ConditionList"=>{"Condition"=>["Arthritis"]}}, "DescriptionModule"=>{"BriefSummary"=>"Research has shown that people with arthritis can improve their ability to cope with arthritis pain with the help of patient education programs, which teach people things they can do to help manage their disease. However, we do not know much about the effects of arthritis patient education programs on minorities, such as urban African Americans.\n\nWe will gather participants for this project through a faith-based community network. The project is made up of four studies that will provide information about culturally relevant ways of reaching urban African Americans with arthritis and providing patient education that addresses arthritis care needs of the African American community. This project will also provide information on the effectiveness of an arthritis self-help course for urban African Americans. We hope to better understand the differences among cultural groups and how these differences should affect the design of culturally appropriate patient education.", "DetailedDescription"=>"Clinical studies have shown that arthritis patient education interventions are an effective addition to medical treatment in improving patients' ability to cope with pain, thereby reducing perceived symptom severity, improving patients' ability to help themselves, and providing them with skills and strategies for dealing with limits on daily activities. We know little, however, about generalizing the effects of such programs to cultural minority groups, such as urban African Americans. We know even less about the longevity of any benefits of patient education or about effective reinforcement and maintenance techniques. To examine these issues, we will recruit participants for this project through a faith-based community network to pursue the following aims:\n\nEvaluate the impact of arthritis patient education on arthritis symptoms and pain levels, functional status, self-care knowledge and behaviors, self-efficacy, emotional status, and health care resource use through a randomized controlled trial (Study 1).\nTest the impact of focused reinforcement of the concepts in the Arthritis Self-Help Course (ASHC) over a 12-month period through a randomized controlled trial (Study 2).\nExamine the detailed educational dynamics of the ASHC, identify aspects of the course that are less effective with or relevant to African Americans, and identify modes of communication and presentation used in the course that require adaptation for an African American audience (Study 3).\nAssess the personal and cultural belief systems underlying African Americans' understanding of arthritis and their use of conventional and unconventional arthritis treatments (Study 4).\n\nThese studies will provide valuable information regarding culturally relevant methods of reaching urban African Americans with arthritis and providing patient education that addresses arthritis care needs of the African American community. This study will also clarify the longevity of educational benefits and the effectiveness of alternative methods of educational reinforcement in this population. The exploratory studies of individual beliefs and knowledge of arthritis and its treatment, and the formal evaluation of a patient education program, will provide a better understanding of the ways in which cultural groups differ and how these differences should influence the design and delivery of culturally appropriate patient education."}, "EligibilityModule"=>{"Gender"=>"All", "MinimumAge"=>"18 years", "StdAgeList"=>{"StdAge"=>["Adult", "Older Adult"]}, "HealthyVolunteers"=>"No", "EligibilityCriteria"=>"Inclusion Criteria:\n\nUrban African Americans with arthritis\n18 years or older\n\nExclusion Criteria:\n\nNone"}, "IdentificationModule"=>{"NCTId"=>"NCT00000396", "BriefTitle"=>"Arthritis Patient Education for Urban African Americans", "Organization"=>{"OrgClass"=>"OTHER", "OrgFullName"=>"University of Michigan"}, "OfficialTitle"=>"Evaluating/Reinforcing Arthritis Patient Education for Urban African Americans", "OrgStudyIdInfo"=>{"OrgStudyId"=>"P60AR020557", "OrgStudyIdLink"=>"https://reporter.nih.gov/quickSearch/P60AR020557", "OrgStudyIdType"=>"U.S. NIH Grant/Contract"}, "SecondaryIdInfoList"=>{"SecondaryIdInfo"=>[{"SecondaryId"=>"P60AR020557", "SecondaryIdLink"=>"https://reporter.nih.gov/quickSearch/P60AR020557", "SecondaryIdType"=>"U.S. NIH Grant/Contract"}, {"SecondaryId"=>"NIAMS-016"}]}}, "ArmsInterventionsModule"=>{"ArmGroupList"=>{"ArmGroup"=>[{"ArmGroupType"=>"Experimental", "ArmGroupLabel"=>"1", "ArmGroupDescription"=>"Education in Arthritis Self-Help Course", "ArmGroupInterventionList"=>{"ArmGroupInterventionName"=>["Behavioral: Patient self-care education"]}}]}, "InterventionList"=>{"Intervention"=>[{"InterventionName"=>"Patient self-care education", "InterventionType"=>"Behavioral", "InterventionArmGroupLabelList"=>{"InterventionArmGroupLabel"=>["1"]}}]}}, "ContactsLocationsModule"=>{"LocationList"=>{"Location"=>[{"LocationZip"=>"49109-0201", "LocationCity"=>"Ann Arbor", "LocationState"=>"Michigan", "LocationCountry"=>"United States", "LocationFacility"=>"University of Michigan"}]}, "OverallOfficialList"=>{"OverallOfficial"=>[{"OverallOfficialName"=>"Larry D. Gruppen, PhD", "OverallOfficialRole"=>"Principal Investigator", "OverallOfficialAffiliation"=>"University of Michigan"}]}}, "SponsorCollaboratorsModule"=>{"LeadSponsor"=>{"LeadSponsorName"=>"University of Michigan", "LeadSponsorClass"=>"OTHER"}, "CollaboratorList"=>{"Collaborator"=>[{"CollaboratorName"=>"National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)", "CollaboratorClass"=>"NIH"}]}, "ResponsibleParty"=>{"ResponsiblePartyType"=>"Principal Investigator", "ResponsiblePartyInvestigatorTitle"=>"Professor of Medical Education", "ResponsiblePartyInvestigatorFullName"=>"Larry Gruppen", "ResponsiblePartyInvestigatorAffiliation"=>"University of Michigan"}}}}}}
