Nctid:
NCT00000417
Payload:
{"FullStudy"=>{"Rank"=>474892, "Study"=>{"DerivedSection"=>{"MiscInfoModule"=>{"VersionHolder"=>"December 06, 2023"}, "ConditionBrowseModule"=>{"ConditionMeshList"=>{"ConditionMesh"=>[{"ConditionMeshId"=>"D000008180", "ConditionMeshTerm"=>"Lupus Erythematosus, Systemic"}]}, "ConditionAncestorList"=>{"ConditionAncestor"=>[{"ConditionAncestorId"=>"D000003240", "ConditionAncestorTerm"=>"Connective Tissue Diseases"}, {"ConditionAncestorId"=>"D000001327", "ConditionAncestorTerm"=>"Autoimmune Diseases"}, {"ConditionAncestorId"=>"D000007154", "ConditionAncestorTerm"=>"Immune System Diseases"}]}, "ConditionBrowseLeafList"=>{"ConditionBrowseLeaf"=>[{"ConditionBrowseLeafId"=>"M10867", "ConditionBrowseLeafName"=>"Lupus Erythematosus, Systemic", "ConditionBrowseLeafAsFound"=>"Systemic Lupus Erythematosus", "ConditionBrowseLeafRelevance"=>"high"}, {"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"=>"Skin and Connective Tissue Diseases", "ConditionBrowseBranchAbbrev"=>"BC17"}, {"ConditionBrowseBranchName"=>"Immune System Diseases", "ConditionBrowseBranchAbbrev"=>"BC20"}, {"ConditionBrowseBranchName"=>"All Conditions", "ConditionBrowseBranchAbbrev"=>"All"}]}}}, "ProtocolSection"=>{"DesignModule"=>{"PhaseList"=>{"Phase"=>["Phase 2"]}, "StudyType"=>"Interventional", "DesignInfo"=>{"DesignAllocation"=>"Randomized", "DesignMaskingInfo"=>{"DesignMasking"=>"None (Open Label)"}, "DesignPrimaryPurpose"=>"Treatment", "DesignInterventionModel"=>"Single Group Assignment"}, "EnrollmentInfo"=>{"EnrollmentCount"=>"150"}}, "StatusModule"=>{"OverallStatus"=>"Completed", "StartDateStruct"=>{"StartDate"=>"April 1997"}, "ExpandedAccessInfo"=>{"HasExpandedAccess"=>"No"}, "StatusVerifiedDate"=>"December 2013", "CompletionDateStruct"=>{"CompletionDate"=>"March 2001", "CompletionDateType"=>"Actual"}, "LastUpdateSubmitDate"=>"December 23, 2013", "StudyFirstSubmitDate"=>"November 3, 1999", "StudyFirstSubmitQCDate"=>"November 3, 1999", "LastUpdatePostDateStruct"=>{"LastUpdatePostDate"=>"December 24, 2013", "LastUpdatePostDateType"=>"Estimate"}, "StudyFirstPostDateStruct"=>{"StudyFirstPostDate"=>"November 4, 1999", "StudyFirstPostDateType"=>"Estimate"}, "PrimaryCompletionDateStruct"=>{"PrimaryCompletionDate"=>"March 2001", "PrimaryCompletionDateType"=>"Actual"}}, "OversightModule"=>{}, "ConditionsModule"=>{"KeywordList"=>{"Keyword"=>["SLE", "Lupus", "Educational intervention", "Health education", "Social support network", "Outcomes research", "Self-help"]}, "ConditionList"=>{"Condition"=>["Systemic Lupus Erythematosus"]}}, "ReferencesModule"=>{"ReferenceList"=>{"Reference"=>[{"ReferencePMID"=>"15188360", "ReferenceType"=>"background", "ReferenceCitation"=>"Karlson EW, Liang MH, Eaton H, Huang J, Fitzgerald L, Rogers MP, Daltroy LH. A randomized clinical trial of a psychoeducational intervention to improve outcomes in systemic lupus erythematosus. Arthritis Rheum. 2004 Jun;50(6):1832-41. doi: 10.1002/art.20279."}]}}, "DescriptionModule"=>{"BriefSummary"=>"We will study the relationships among patient/partner communication, social support, and self-efficacy (a person's belief in the ability to manage his or her disease) as they affect the health of people with systemic lupus erythematosus (SLE, or lupus) over time. We are assigning 150 people with lupus and their partners to either (1) receive counseling to improve self-efficacy, partner support, and patient/partner problem solving or (2) see an informational film about lupus. We will follow study participants for 12 months to find out about their physical and mental health, disease activity, beliefs that they can take steps that help them feel better, coping, social support, and couples communication.", "DetailedDescription"=>"Studies have shown that patient self-efficacy in disease management and social support predict physical and mental health and disease activity in lupus. We wished to study the relationships among patient/partner communication, social support, and self-efficacy as they influence patient health longitudinally. We are randomizing 150 lupus patients and their partners to either (1) participate in a counseling intervention to improve self-efficacy, partner support, and patient/partner problem-solving in lupus management or (2) see an informational film about lupus (control). The counseling intervention includes an initial in-person session followed by five monthly telephone calls to monitor and reinforce problem-solving. We will follow patients for 12 months for self-reported physical and mental health, disease activity, self-efficacy, coping, social support, and couples communication."}, "EligibilityModule"=>{"Gender"=>"All", "MaximumAge"=>"75 years", "MinimumAge"=>"18 years", "StdAgeList"=>{"StdAge"=>["Adult", "Older Adult"]}, "HealthyVolunteers"=>"No", "EligibilityCriteria"=>"Inclusion Criteria:\n\nHas partner willing to participate in study\n\nExclusion Criteria:\n\nUnable to read and write English questionnaires\nUnable to be reached by phone\nRheumatologist considers patient unable to participate, generally due to patient cognitive problems or severe illness"}, "IdentificationModule"=>{"NCTId"=>"NCT00000417", "BriefTitle"=>"Psychoeducational Approach to Improve Health in Lupus", "Organization"=>{"OrgClass"=>"OTHER", "OrgFullName"=>"Brigham and Women's Hospital"}, "OfficialTitle"=>"A Randomized Controlled Trial of a Psychoeducational Intervention to Improve Outcomes in Systemic Lupus Erythematosus (SLE)", "OrgStudyIdInfo"=>{"OrgStudyId"=>"P60 AR36308 NIAMS-014"}, "SecondaryIdInfoList"=>{"SecondaryIdInfo"=>[{"SecondaryId"=>"P60AR036308", "SecondaryIdLink"=>"https://reporter.nih.gov/quickSearch/P60AR036308", "SecondaryIdType"=>"U.S. NIH Grant/Contract"}]}}, "ArmsInterventionsModule"=>{"InterventionList"=>{"Intervention"=>[{"InterventionName"=>"Counseling intervention", "InterventionType"=>"Procedure"}, {"InterventionName"=>"Informational film", "InterventionType"=>"Device"}]}}, "ContactsLocationsModule"=>{"LocationList"=>{"Location"=>[{"LocationZip"=>"02115", "LocationCity"=>"Boston", "LocationState"=>"Massachusetts", "LocationCountry"=>"United States", "LocationFacility"=>"Brigham & Women's Hospital"}]}, "OverallOfficialList"=>{"OverallOfficial"=>[{"OverallOfficialName"=>"Lawren H. Daltroy, DrPH", "OverallOfficialRole"=>"Principal Investigator", "OverallOfficialAffiliation"=>"Brigham and Women's Hospital"}]}}, "SponsorCollaboratorsModule"=>{"LeadSponsor"=>{"LeadSponsorName"=>"Brigham and Women's Hospital", "LeadSponsorClass"=>"OTHER"}, "CollaboratorList"=>{"Collaborator"=>[{"CollaboratorName"=>"National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)", "CollaboratorClass"=>"NIH"}]}, "ResponsibleParty"=>{"ResponsiblePartyType"=>"Principal Investigator", "ResponsiblePartyInvestigatorTitle"=>"Professor of Medicine", "ResponsiblePartyInvestigatorFullName"=>"Matthew H. Liang, MD", "ResponsiblePartyInvestigatorAffiliation"=>"Brigham and Women's Hospital"}}}}}}
