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Study of Individualized Instruction Versus Pamphlet in Systemic Lupus Erythematosus

Randomized Study of Individualized Instruction Versus Pamphlet in Systemic Lupus Erythematosus

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00004756
Enrollment
150
Registered
2000-02-25
Start date
1994-12-31
Completion date
Unknown
Last updated
2005-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Systemic Lupus Erythematosus

Keywords

arthritis & connective tissue diseases, disease-related problem/condition, educational needs, immunologic disorders and infectious disorders, rare disease, systemic lupus erythematosus

Brief 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.

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.

Interventions

PROCEDURETailored educational program
PROCEDUREEducational materials

Sponsors

Virginia Commonwealth University
CollaboratorOTHER
National Center for Research Resources (NCRR)
Lead SponsorNIH

Study design

Allocation
RANDOMIZED
Primary purpose
ECT

Eligibility

Sex/Gender
ALL
Age
0 Years to No maximum
Healthy volunteers
No

Inclusion criteria

PROTOCOL ENTRY CRITERIA: Confirmed systemic lupus erythematosus (SLE) using American College of Rheumatology criteria Recruitment from the Medical College of Virginia SLE registry

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026