Nctid:
NCT00000414
Payload:
{"FullStudy"=>{"Rank"=>475194, "Study"=>{"DerivedSection"=>{"MiscInfoModule"=>{"VersionHolder"=>"December 08, 2023"}, "ConditionBrowseModule"=>{"ConditionMeshList"=>{"ConditionMesh"=>[{"ConditionMeshId"=>"D000001168", "ConditionMeshTerm"=>"Arthritis"}, {"ConditionMeshId"=>"D000010003", "ConditionMeshTerm"=>"Osteoarthritis"}, {"ConditionMeshId"=>"D000001172", "ConditionMeshTerm"=>"Arthritis, Rheumatoid"}]}, "ConditionAncestorList"=>{"ConditionAncestor"=>[{"ConditionAncestorId"=>"D000007592", "ConditionAncestorTerm"=>"Joint Diseases"}, {"ConditionAncestorId"=>"D000009140", "ConditionAncestorTerm"=>"Musculoskeletal Diseases"}, {"ConditionAncestorId"=>"D000012216", "ConditionAncestorTerm"=>"Rheumatic Diseases"}, {"ConditionAncestorId"=>"D000003240", "ConditionAncestorTerm"=>"Connective Tissue Diseases"}, {"ConditionAncestorId"=>"D000001327", "ConditionAncestorTerm"=>"Autoimmune Diseases"}, {"ConditionAncestorId"=>"D000007154", "ConditionAncestorTerm"=>"Immune System Diseases"}]}, "ConditionBrowseLeafList"=>{"ConditionBrowseLeaf"=>[{"ConditionBrowseLeafId"=>"M4166", "ConditionBrowseLeafName"=>"Arthritis", "ConditionBrowseLeafAsFound"=>"Arthritis", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"M12616", "ConditionBrowseLeafName"=>"Osteoarthritis", "ConditionBrowseLeafAsFound"=>"Osteoarthritis", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"M4170", "ConditionBrowseLeafName"=>"Arthritis, Rheumatoid", "ConditionBrowseLeafAsFound"=>"Rheumatoid Arthritis", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"M10311", "ConditionBrowseLeafName"=>"Joint Diseases", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M11787", "ConditionBrowseLeafName"=>"Musculoskeletal Diseases", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M14735", "ConditionBrowseLeafName"=>"Rheumatic Diseases", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M6013", "ConditionBrowseLeafName"=>"Collagen Diseases", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M6154", "ConditionBrowseLeafName"=>"Connective Tissue Diseases", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M4319", "ConditionBrowseLeafName"=>"Autoimmune Diseases", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M9890", "ConditionBrowseLeafName"=>"Immune System Diseases", "ConditionBrowseLeafRelevance"=>"low"}]}, "ConditionBrowseBranchList"=>{"ConditionBrowseBranch"=>[{"ConditionBrowseBranchName"=>"Musculoskeletal Diseases", "ConditionBrowseBranchAbbrev"=>"BC05"}, {"ConditionBrowseBranchName"=>"All Conditions", "ConditionBrowseBranchAbbrev"=>"All"}, {"ConditionBrowseBranchName"=>"Skin and Connective Tissue Diseases", "ConditionBrowseBranchAbbrev"=>"BC17"}, {"ConditionBrowseBranchName"=>"Immune System Diseases", "ConditionBrowseBranchAbbrev"=>"BC20"}]}}}, "ProtocolSection"=>{"DesignModule"=>{"PhaseList"=>{"Phase"=>["Not Applicable"]}, "StudyType"=>"Interventional", "DesignInfo"=>{"DesignAllocation"=>"Randomized", "DesignMaskingInfo"=>{"DesignMasking"=>"None (Open Label)"}, "DesignPrimaryPurpose"=>"Treatment", "DesignInterventionModel"=>"Parallel Assignment"}, "EnrollmentInfo"=>{"EnrollmentType"=>"Actual", "EnrollmentCount"=>"1200"}}, "StatusModule"=>{"OverallStatus"=>"Completed", "StartDateStruct"=>{"StartDate"=>"July 1996"}, "ExpandedAccessInfo"=>{"HasExpandedAccess"=>"No"}, "StatusVerifiedDate"=>"November 2004", "CompletionDateStruct"=>{"CompletionDate"=>"April 2001", "CompletionDateType"=>"Actual"}, "LastUpdateSubmitDate"=>"June 19, 2013", "StudyFirstSubmitDate"=>"November 3, 1999", "StudyFirstSubmitQCDate"=>"November 3, 1999", "LastUpdatePostDateStruct"=>{"LastUpdatePostDate"=>"June 21, 2013", "LastUpdatePostDateType"=>"Estimate"}, "StudyFirstPostDateStruct"=>{"StudyFirstPostDate"=>"November 4, 1999", "StudyFirstPostDateType"=>"Estimate"}, "PrimaryCompletionDateStruct"=>{"PrimaryCompletionDate"=>"April 2001", "PrimaryCompletionDateType"=>"Actual"}}, "OversightModule"=>{"OversightHasDMC"=>"No"}, "ConditionsModule"=>{"KeywordList"=>{"Keyword"=>["Rheumatoid arthritis (RA)", "Osteoarthritis (OA)", "Arthritis education", "Health care service evaluation", "Outcomes research", "Arthritis Self-Management Program (ASMP)", "Self-Managed Arthritis Relief Therapy (SMART) Program"]}, "ConditionList"=>{"Condition"=>["Rheumatoid Arthritis", "Osteoarthritis"]}}, "ReferencesModule"=>{"ReferenceList"=>{"Reference"=>[{"ReferencePMID"=>"15076811", "ReferenceType"=>"background", "ReferenceCitation"=>"Lorig KR, Ritter PL, Laurent DD, Fries JF. Long-term randomized controlled trials of tailored-print and small-group arthritis self-management interventions. Med Care. 2004 Apr;42(4):346-54. doi: 10.1097/01.mlr.0000118709.74348.65."}]}}, "DescriptionModule"=>{"BriefSummary"=>"This project will evaluate the effectiveness and general usefulness of two arthritis patient education programs. The first, the Arthritis Self-Management Program, is a 6-week, community-based program taught in small groups by peer leaders. The second, the Self-Managed Arthritis Relief Therapy (SMART) Program, is a computer-driven program delivered through the mail. Participants in this project are people with rheumatoid arthritis or osteoarthritis who are taking part in the larger long-term studies being conducted by ARAMIS (the Arthritis, Rheumatism and Aging Medical Information System).", "DetailedDescription"=>"In a changing health care environment, the role of patients in managing their arthritis is increasingly important. Patient education is the primary means for teaching patients how to fulfill this role successfully. The goal of self-management health education is not merely to provide information but also to change patient attitudes and behavior so that patient outcomes are improved. These programs represent a new treatment for arthritis.\n\nThis project will evaluate the relative effect on health status and cost-effectiveness of two arthritis patient education programs that use different delivery systems. The Arthritis Self-Management Program (ASMP) uses a small group, multi-class format. It is taught by trained lay leaders and has been evaluated for effectiveness and widely disseminated. The Self-Managed Arthritis Relief Therapy (SMART) Program is a computer-driven, individualized, mail-delivered intervention. Results of a pilot study suggest that it is effective in improving health status and reducing health care use.\n\nThe project will also evaluate how generalizable the SMART program is and its effectiveness for patients with different diagnoses (OA and RA). It will also determine the attributes of patients who choose and do not choose to participate in patient education programs as well as the attributes of those who complete and do not complete the ASMP and SMART programs.\n\nThrough use of the ARAMIS data collection system, the project allows us to describe the differences between people who volunteer to receive patient education and those who refuse patient education. This project is directed at improving patient outcomes in both RA and OA through wide availability of a low-cost, mail-delivered arthritis self-management program that is the next generation in arthritis health education."}, "EligibilityModule"=>{"Gender"=>"All", "MinimumAge"=>"18 years", "StdAgeList"=>{"StdAge"=>["Adult", "Older Adult"]}, "HealthyVolunteers"=>"No", "EligibilityCriteria"=>"Inclusion Criteria:\n\nPhysician diagnosis of OA or RA\nParticipation in the ARAMIS longitudinal study\n\nExclusion Criteria:\n\nAge under 18"}, "IdentificationModule"=>{"NCTId"=>"NCT00000414", "BriefTitle"=>"Patient Education in Rheumatoid Arthritis and Osteoarthritis", "Organization"=>{"OrgClass"=>"OTHER", "OrgFullName"=>"Stanford University"}, "OfficialTitle"=>"Patient Education Strategies for Better Outcomes in Rheumatoid Arthritis (RA) and Osteoarthritis (OA)", "OrgStudyIdInfo"=>{"OrgStudyId"=>"P01 AR43584 Substudy 004"}, "SecondaryIdInfoList"=>{"SecondaryIdInfo"=>[{"SecondaryId"=>"P01AR043584", "SecondaryIdLink"=>"https://reporter.nih.gov/quickSearch/P01AR043584", "SecondaryIdType"=>"U.S. NIH Grant/Contract"}]}}, "ArmsInterventionsModule"=>{"ArmGroupList"=>{"ArmGroup"=>[{"ArmGroupType"=>"Experimental", "ArmGroupLabel"=>"Arthritis Self-Management Program", "ArmGroupDescription"=>"small group self-management program", "ArmGroupInterventionList"=>{"ArmGroupInterventionName"=>["Behavioral: Arthritis Self-Management Program"]}}, {"ArmGroupType"=>"Experimental", "ArmGroupLabel"=>"SMART Program", "ArmGroupDescription"=>"Self-Managed Arthritis Relief Therapy: mailed self management material", "ArmGroupInterventionList"=>{"ArmGroupInterventionName"=>["Behavioral: SMART Program"]}}]}, "InterventionList"=>{"Intervention"=>[{"InterventionName"=>"Arthritis Self-Management Program", "InterventionType"=>"Behavioral", "InterventionArmGroupLabelList"=>{"InterventionArmGroupLabel"=>["Arthritis Self-Management Program"]}}, {"InterventionName"=>"SMART Program", "InterventionType"=>"Behavioral", "InterventionOtherNameList"=>{"InterventionOtherName"=>["Self-Managed Arthritis Relief Therapy (SMART)"]}, "InterventionArmGroupLabelList"=>{"InterventionArmGroupLabel"=>["SMART Program"]}}]}}, "ContactsLocationsModule"=>{"LocationList"=>{"Location"=>[{"LocationZip"=>"94305", "LocationCity"=>"Palo Alto", "LocationState"=>"California", "LocationCountry"=>"United States", "LocationFacility"=>"Stanford University"}, {"LocationCity"=>"Wichita", "LocationState"=>"Kansas", "LocationCountry"=>"United States", "LocationFacility"=>"Wichita Arthritis Center"}, {"LocationCity"=>"Pittsburgh", "LocationState"=>"Pennsylvania", "LocationCountry"=>"United States", "LocationFacility"=>"University of Pittsburgh"}, {"LocationCity"=>"Nashville", "LocationState"=>"Tennessee", "LocationCountry"=>"United States", "LocationFacility"=>"Vanderbilt University"}, {"LocationCity"=>"Edmonton", "LocationState"=>"Alberta", "LocationCountry"=>"Canada", "LocationFacility"=>"University of Saskatoon"}]}, "OverallOfficialList"=>{"OverallOfficial"=>[{"OverallOfficialName"=>"Kate R. Lorig, DrPH", "OverallOfficialRole"=>"Principal Investigator", "OverallOfficialAffiliation"=>"Stanford University"}]}}, "SponsorCollaboratorsModule"=>{"LeadSponsor"=>{"LeadSponsorName"=>"Stanford University", "LeadSponsorClass"=>"OTHER"}, "CollaboratorList"=>{"Collaborator"=>[{"CollaboratorName"=>"National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)", "CollaboratorClass"=>"NIH"}]}, "ResponsibleParty"=>{"ResponsiblePartyType"=>"Principal Investigator", "ResponsiblePartyInvestigatorTitle"=>"professor", "ResponsiblePartyInvestigatorFullName"=>"Kate Lorig", "ResponsiblePartyInvestigatorAffiliation"=>"Stanford University"}}}}}}
