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Study of Individualized Instruction Versus Pamphlet in Systemic Lupus Erythematosus

N

National Center for Research Resources (NCRR)

Status

Completed

Conditions

Systemic Lupus Erythematosus

Treatments

Procedure: Educational materials
Procedure: Tailored educational program

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT00004756
VCU-92123A
199/11686

Details and patient eligibility

About

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.

Full 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.

Sex

All

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

PROTOCOL ENTRY CRITERIA:

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

Recruitment from the Medical College of Virginia SLE registry

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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