This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

Study of Individualized Instruction Versus Pamphlet in Systemic Lupus Erythematosus

This study has been completed.
Virginia Commonwealth University
Information provided by:
Office of Rare Diseases (ORD) Identifier:
First received: February 24, 2000
Last updated: June 23, 2005
Last verified: December 2001


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
Systemic Lupus Erythematosus Procedure: Tailored educational program Procedure: Educational materials

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Educational/Counseling/Training
Official Title: Randomized Study of Individualized Instruction Versus Pamphlet in Systemic Lupus Erythematosus

Resource links provided by NLM:

Further study details as provided by Office of Rare Diseases (ORD):

Estimated Enrollment: 150
Study Start Date: December 1994
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.


Ages Eligible for Study:   Child, Adult, Senior
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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00004756

Sponsors and Collaborators
National Center for Research Resources (NCRR)
Virginia Commonwealth University
Study Chair: W. Neal Roberts Virginia Commonwealth University
  More Information Identifier: NCT00004756     History of Changes
Other Study ID Numbers: 199/11686
Study First Received: February 24, 2000
Last Updated: June 23, 2005

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 processed this record on August 17, 2017