Study of Individualized Instruction Versus Pamphlet in Systemic Lupus Erythematosus

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.

Completed

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Key information

Conditions

Systemic Lupus Erythematosus Arthritis Autoimmune Diseases Communicable Diseases Connective Tissue Diseases Disease Attributes Immune System Diseases Infections Joint Diseases Lupus Erythematosus, Systemic Musculoskeletal Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Rare Diseases Skin and Connective Tissue Diseases

Age range

0 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

PROTOCOL ENTRY CRITERIA:

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

Recruitment from the Medical College of Virginia SLE registry

Treatment and study plan

Tailored educational program

Procedure

Educational materials

Procedure

Sponsors and collaborators

Lead sponsor

National Center for Research Resources (NCRR)

Nih

Collaborators

Virginia Commonwealth University

Registry information

Official study title

Randomized Study of Individualized Instruction Versus Pamphlet in Systemic Lupus Erythematosus

Important dates

Study start: 1994
First posted: Feb 25, 2000
Registry last updated: Jun 24, 2005

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed