Study of Individualized Instruction Versus Pamphlet in Systemic Lupus Erythematosus - Full Text View

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

Study ID Numbers:	199/11686, VCU-92123A
First Received:	February 24, 2000
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00004756
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

Arthritis

Rare Diseases

Connective Tissue Diseases

Additional relevant MeSH terms:

Immune System Diseases

ClinicalTrials.gov processed this record on November 20, 2008

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