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NCT00004756 Clinical Trial

Study of Individualized Instruction Versus Pamphlet in Systemic Lupus Erythematosus

Systemic Lupus Erythematosus Clinical Trial

Official title:
Randomized Study of Individualized Instruction Versus Pamphlet in Systemic Lupus Erythematosus

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00004756
Other study ID # 199/11686
Secondary ID VCU-92123A
Status Completed
Phase N/A
First received February 24, 2000
Last updated June 23, 2005
Start date December 1994

Study information
Verified date December 2001
Source Office of Rare Diseases (ORD)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 150
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility PROTOCOL ENTRY CRITERIA:

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

Recruitment from the Medical College of Virginia SLE registry

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Primary Purpose: Educational/Counseling/Training

Related Conditions & MeSH terms

Intervention

Procedure:
• Tailored educational program

• Educational materials

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
National Center for Research Resources (NCRR) Virginia Commonwealth University
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