Clinical Trials Directory

Trials / Completed

CompletedNCT00004756

Study of Individualized Instruction Versus Pamphlet in Systemic Lupus Erythematosus

Randomized Study of Individualized Instruction Versus Pamphlet in Systemic Lupus Erythematosus

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
150 (planned)
Sponsor
National Center for Research Resources (NCRR) · NIH
Sex
All
Age
0 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
PROCEDURETailored educational program
PROCEDUREEducational materials

Timeline

Start date
1994-12-01
First posted
2000-02-25
Last updated
2005-06-24

Source: ClinicalTrials.gov record NCT00004756. Inclusion in this directory is not an endorsement.