Ignite Creation Date:
2025-12-24 @ 11:15 PM
Ignite Modification Date:
2025-12-25 @ 8:52 PM
Study NCT ID:
NCT00004756
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
2000-02-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study of Individualized Instruction Versus Pamphlet in Systemic Lupus Erythematosus
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008180', 'term': 'Lupus Erythematosus, Systemic'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D035583', 'term': 'Rare Diseases'}], 'ancestors': [{'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'primaryPurpose': 'ECT'}, 'enrollmentInfo': {'count': 150}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1994-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2001-12', 'lastUpdateSubmitDate': '2005-06-23', 'studyFirstSubmitDate': '2000-02-24', 'studyFirstSubmitQcDate': '2000-02-24', 'lastUpdatePostDateStruct': {'date': '2005-06-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2000-02-25', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['arthritis & connective tissue diseases', 'disease-related problem/condition', 'educational needs', 'immunologic disorders and infectious disorders', 'rare disease', 'systemic lupus erythematosus'], 'conditions': ['Systemic Lupus Erythematosus']}, 'descriptionModule': {'briefSummary': 'OBJECTIVES:\n\nI. Evaluate an educational program that has been pretested for cultural appropriateness and literacy requirements in patients with systemic lupus erythematosus (SLE).\n\nII. Assess the impact of this educational program on patients with SLE, with an emphasis on recognizing cardinal symptoms, coping with fatigue, regulating medications, and communicating with the physician.', 'detailedDescription': 'PROTOCOL OUTLINE:\n\nPatients are randomly assigned to 1 of 2 groups.\n\nOne group participates in an educational program administered and coordinated by a health educator. The program includes 1 or 2 educational sessions emphasizing practical advice, each lasting approximately 1.5 hours; social support from a patient-identified management partner; and behavioral reinforcement from health center staff, the patient partner, and written and audio materials.\n\nThe control group receives patient educational materials consistent with usual care (pamphlets).\n\nPatients are followed at 6, 12, 24, and 36 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '0 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'PROTOCOL ENTRY CRITERIA:\n\nConfirmed systemic lupus erythematosus (SLE) using American College of Rheumatology criteria\n\nRecruitment from the Medical College of Virginia SLE registry'}, 'identificationModule': {'nctId': 'NCT00004756', 'briefTitle': 'Study of Individualized Instruction Versus Pamphlet in Systemic Lupus Erythematosus', 'organization': {'class': 'NIH', 'fullName': 'Office of Rare Diseases (ORD)'}, 'officialTitle': 'Randomized Study of Individualized Instruction Versus Pamphlet in Systemic Lupus Erythematosus', 'orgStudyIdInfo': {'id': '199/11686'}, 'secondaryIdInfos': [{'id': 'VCU-92123A'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Tailored educational program', 'type': 'PROCEDURE'}, {'name': 'Educational materials', 'type': 'PROCEDURE'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'W. Neal Roberts', 'role': 'STUDY_CHAIR', 'affiliation': 'Virginia Commonwealth University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Center for Research Resources (NCRR)', 'class': 'NIH'}, 'collaborators': [{'name': 'Virginia Commonwealth University', 'class': 'OTHER'}]}}}