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Home > "S" Clinical Trials Conditions > Study of Individualized Instruction versus Pamphlet in Systemic Lupus Erythematosus  Study of Individualized Instruction versus Pamphlet in Systemic Lupus Erythematosus
Study of Individualized Instruction versus Pamphlet in Systemic Lupus Erythematosus
For Condition: Systemic Lupus Erythematosus
Status: Completed
Sponsor(s): National Center for Research Resources (NCRR) , Virginia Commonwealth University
Synopsis: 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.
Details: 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.
Eligibility:
Study Type: Interventional, Educational/Counseling/Training, Randomized, Efficacy Study
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: Confirmed systemic lupus erythematosus (SLE) using American College of Rheumatology criteria Recruitment from the Medical College of Virginia SLE registry
Total Enrollment: 150
Location and Contact Information:
Overall Study Official:
W.Roberts, Study Chair, Virginia Commonwealth University
Additional Information:
Study ID Numbers: 199/11686; VCU-92123A
Study Start Date: December 1994
Record last reviewed: December 2001
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004756
Other Systemic Lupus Erythematosus Studies:
1. Phase III Randomized, Double-Blind, Placebo-Controlled Study of Dehydroepiandrosterone in Women with Active Systemic Lupus Erythematosus
2. Study of Families with Twins or Siblings Discordant for Rheumatic Disorders
3. Safety of Estrogens in Lupus: Birth Control Pills
4. Pilot Study of Total Body Irradiation in Combination With Cyclophosphamide, Anti-thymocyte Globulin, and Autologous CD34-Selected Peripheral Blood Stem Cell Transplantation in Children With Refractory Autoimmune Disorders
5. Monoclonal Antibody Treatment for Systemic Lupus Erythematosus
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Study of Individualized Instruction versus Pamphlet in Systemic Lupus Erythematosus
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