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Sponsors and Collaborators: |
National Center for Research Resources (NCRR) Virginia Commonwealth University |
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Information provided by: | Office of Rare Diseases (ORD) |
ClinicalTrials.gov Identifier: | NCT00004756 |
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.
Condition | Intervention |
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Systemic Lupus Erythematosus |
Procedure: Tailored educational program Procedure: Educational materials |
Study Type: | Interventional |
Study Design: | Educational/Counseling/Training, Randomized, Efficacy Study |
Official Title: | Randomized Study of Individualized Instruction Versus Pamphlet in Systemic Lupus Erythematosus |
Estimated Enrollment: | 150 |
Study Start Date: | December 1994 |
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.
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
PROTOCOL ENTRY CRITERIA:
Confirmed systemic lupus erythematosus (SLE) using American College of Rheumatology criteria
Recruitment from the Medical College of Virginia SLE registry
Study ID Numbers: | 199/11686, VCU-92123A |
Study First Received: | February 24, 2000 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00004756 |
Health Authority: | United States: Federal Government |
arthritis & connective tissue diseases disease-related problem/condition educational needs |
immunologic disorders and infectious disorders rare disease systemic lupus erythematosus |
Autoimmune Diseases Lupus Erythematosus, Systemic Arthritis Rare Diseases Connective Tissue Diseases |
Immune System Diseases |