Study of Individualized Instruction Versus Pamphlet in Systemic Lupus Erythematosus

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00004756
Recruitment Status : Completed
First Posted : February 25, 2000
Last Update Posted : June 24, 2005
Virginia Commonwealth University
Information provided by:
Office of Rare Diseases (ORD)

Brief Summary:


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 or disease Intervention/treatment Phase
Systemic Lupus Erythematosus Procedure: Tailored educational program Procedure: Educational materials Not Applicable

Detailed Description:


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.

Study Type : Interventional  (Clinical Trial)
Enrollment : 150 participants
Allocation: Randomized
Primary Purpose: Educational/Counseling/Training
Official Title: Randomized Study of Individualized Instruction Versus Pamphlet in Systemic Lupus Erythematosus
Study Start Date : December 1994

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lupus

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


Confirmed systemic lupus erythematosus (SLE) using American College of Rheumatology criteria

Recruitment from the Medical College of Virginia SLE registry

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00004756

Sponsors and Collaborators
National Center for Research Resources (NCRR)
Virginia Commonwealth University
Study Chair: W. Neal Roberts Virginia Commonwealth University Identifier: NCT00004756     History of Changes
Other Study ID Numbers: 199/11686
First Posted: February 25, 2000    Key Record Dates
Last Update Posted: June 24, 2005
Last Verified: December 2001

Keywords provided by Office of Rare Diseases (ORD):
arthritis & connective tissue diseases
disease-related problem/condition
educational needs
immunologic disorders and infectious disorders
rare disease
systemic lupus erythematosus

Additional relevant MeSH terms:
Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases