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| Tracking Information | |||||
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| First Received Date ICMJE | February 24, 2000 | ||||
| Last Updated Date | June 23, 2005 | ||||
| Start Date ICMJE | December 1994 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE | |||||
| Original Primary Outcome Measures ICMJE | |||||
| Change History | Complete list of historical versions of study NCT00004756 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Study of Individualized Instruction Versus Pamphlet in Systemic Lupus Erythematosus | ||||
| Official Title ICMJE | Randomized Study of Individualized Instruction Versus Pamphlet in Systemic Lupus Erythematosus | ||||
| Brief Summary | OBJECTIVES: I. Evaluate an educational program that has been pretested for cultural appropriateness and literacy requirements in patients with systemic lupus erythematosus (SLE). II. 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. |
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| Detailed Description | PROTOCOL OUTLINE: Patients are randomly assigned to 1 of 2 groups. One 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. The control group receives patient educational materials consistent with usual care (pamphlets). Patients are followed at 6, 12, 24, and 36 months. |
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| Study Phase | |||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Educational/Counseling/Training, Randomized, Efficacy Study | ||||
| Condition ICMJE | Systemic Lupus Erythematosus | ||||
| Intervention ICMJE |
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| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 150 | ||||
| Completion Date | |||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | PROTOCOL ENTRY CRITERIA: Confirmed systemic lupus erythematosus (SLE) using American College of Rheumatology criteria Recruitment from the Medical College of Virginia SLE registry |
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| Gender | Both | ||||
| Ages | |||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | |||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00004756 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | 199/11686, VCU-92123A | ||||
| Study Sponsor ICMJE | National Center for Research Resources (NCRR) | ||||
| Collaborators ICMJE | Virginia Commonwealth University | ||||
| Investigators ICMJE |
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| Information Provided By | Office of Rare Diseases (ORD) | ||||
| Verification Date | December 2001 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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