Study of Individualized Instruction Versus Pamphlet in Systemic Lupus Erythematosus

This study has been completed.

First Received: February 24, 2000 Last Updated: June 23, 2005 History of Changes

Sponsors and Collaborators:	National Center for Research Resources (NCRR) Virginia Commonwealth University
Information provided by:	Office of Rare Diseases (ORD)
ClinicalTrials.gov Identifier:	NCT00004756

Purpose

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

MedlinePlus related topics: Lupus

U.S. FDA Resources

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

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

Estimated Enrollment:	150
Study Start Date:	December 1994

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.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

PROTOCOL ENTRY CRITERIA:

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

Recruitment from the Medical College of Virginia SLE registry

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004756

Sponsors and Collaborators

National Center for Research Resources (NCRR)

Virginia Commonwealth University

Investigators

Study Chair:

W. Neal Roberts

Virginia Commonwealth University

More Information

No publications provided

Study ID Numbers:	199/11686, VCU-92123A
Study First Received:	February 24, 2000
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00004756 History of Changes
Health Authority:	United States: Federal Government

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

Study placed in the following topic categories:

Autoimmune Diseases
Lupus Erythematosus, Systemic
Lupus

Arthritis
Rare Diseases
Connective Tissue Diseases

Additional relevant MeSH terms:

Autoimmune Diseases
Immune System Diseases
Lupus Erythematosus, Systemic
Connective Tissue Diseases

ClinicalTrials.gov processed this record on May 07, 2009