Nctid:
NCT00000417
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-12-20"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D008180", "term"=>"Lupus Erythematosus, Systemic"}], "ancestors"=>[{"id"=>"D003240", "term"=>"Connective Tissue Diseases"}, {"id"=>"D001327", "term"=>"Autoimmune Diseases"}, {"id"=>"D007154", "term"=>"Immune System Diseases"}], "browseLeaves"=>[{"id"=>"M11177", "name"=>"Lupus Erythematosus, Systemic", "asFound"=>"Systemic Lupus Erythematosus", "relevance"=>"HIGH"}, {"id"=>"M6464", "name"=>"Connective Tissue Diseases", "relevance"=>"LOW"}, {"id"=>"M4629", "name"=>"Autoimmune Diseases", "relevance"=>"LOW"}, {"id"=>"M10200", "name"=>"Immune System Diseases", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Skin and Connective Tissue Diseases", "abbrev"=>"BC17"}, {"name"=>"Immune System Diseases", "abbrev"=>"BC20"}, {"name"=>"All Conditions", "abbrev"=>"All"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["PHASE2"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"RANDOMIZED", "maskingInfo"=>{"masking"=>"NONE"}, "primaryPurpose"=>"TREATMENT", "interventionModel"=>"SINGLE_GROUP"}, "enrollmentInfo"=>{"count"=>150}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "startDateStruct"=>{"date"=>"1997-04"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2013-12", "completionDateStruct"=>{"date"=>"2001-03", "type"=>"ACTUAL"}, "lastUpdateSubmitDate"=>"2013-12-23", "studyFirstSubmitDate"=>"1999-11-03", "studyFirstSubmitQcDate"=>"1999-11-03", "lastUpdatePostDateStruct"=>{"date"=>"2013-12-24", "type"=>"ESTIMATED"}, "studyFirstPostDateStruct"=>{"date"=>"1999-11-04", "type"=>"ESTIMATED"}, "primaryCompletionDateStruct"=>{"date"=>"2001-03", "type"=>"ACTUAL"}}, "conditionsModule"=>{"keywords"=>["SLE", "Lupus", "Educational intervention", "Health education", "Social support network", "Outcomes research", "Self-help"], "conditions"=>["Systemic Lupus Erythematosus"]}, "referencesModule"=>{"references"=>[{"pmid"=>"15188360", "type"=>"BACKGROUND", "citation"=>"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"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "maximumAge"=>"75 years", "minimumAge"=>"18 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* Has partner willing to participate in study\n\nExclusion Criteria:\n\n* Unable to read and write English questionnaires\n* Unable to be reached by phone\n* Rheumatologist 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"=>{"class"=>"OTHER", "fullName"=>"Brigham and Women's Hospital"}, "officialTitle"=>"A Randomized Controlled Trial of a Psychoeducational Intervention to Improve Outcomes in Systemic Lupus Erythematosus (SLE)", "orgStudyIdInfo"=>{"id"=>"P60 AR36308 NIAMS-014"}, "secondaryIdInfos"=>[{"id"=>"P60AR036308", "link"=>"https://reporter.nih.gov/quickSearch/P60AR036308", "type"=>"NIH"}]}, "armsInterventionsModule"=>{"interventions"=>[{"name"=>"Counseling intervention", "type"=>"PROCEDURE"}, {"name"=>"Informational film", "type"=>"DEVICE"}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"02115", "city"=>"Boston", "state"=>"Massachusetts", "country"=>"United States", "facility"=>"Brigham & Women's Hospital", "geoPoint"=>{"lat"=>42.35843, "lon"=>-71.05977}}], "overallOfficials"=>[{"name"=>"Lawren H. Daltroy, DrPH", "role"=>"PRINCIPAL_INVESTIGATOR", "affiliation"=>"Brigham and Women's Hospital"}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Brigham and Women's Hospital", "class"=>"OTHER"}, "collaborators"=>[{"name"=>"National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)", "class"=>"NIH"}], "responsibleParty"=>{"type"=>"PRINCIPAL_INVESTIGATOR", "investigatorTitle"=>"Professor of Medicine", "investigatorFullName"=>"Matthew H. Liang, MD", "investigatorAffiliation"=>"Brigham and Women's Hospital"}}}}
