Study of Individualized Instruction Versus Pamphlet in Systemic Lupus Erythematosus

This study has been completed.
Sponsor:
Collaborator:
Virginia Commonwealth University
Information provided by:
Office of Rare Diseases (ORD)
ClinicalTrials.gov Identifier:
NCT00004756
First received: February 24, 2000
Last updated: June 23, 2005
Last verified: December 2001
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
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:

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
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 ClinicalTrials.gov identifier: NCT00004756

Sponsors and Collaborators
Virginia Commonwealth University
Investigators
Study Chair: W. Neal Roberts Virginia Commonwealth University
  More Information

No publications provided

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

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

ClinicalTrials.gov processed this record on October 16, 2014