Not Signed In -
Systemic Lupus Erythematosus |
Sle |
Clinical Trial: Study of Individualized Instruction versus Pamphlet in Systemic Lupus Erythematosus
This study has been completed.
|
Purpose
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.
| Condition | Treatment or Intervention |
|---|---|
| Systemic Lupus Erythematosus | Procedure: Tailored educational program Procedure: Educational materials |
MedlinePlus related topics: Lupus
Study Type: Interventional
Study Design: Educational/Counseling/Training, Randomized, Efficacy Study
Official Title: Randomized Study of Individualized Instruction versus Pamphlet in Systemic Lupus Erythematosus
Expected Total Enrollment: 150
Study start: December 1994
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.
Eligibility
Genders Eligible for Study: Both
Criteria
PROTOCOL ENTRY CRITERIA:
Confirmed systemic lupus erythematosus (SLE) using American College of Rheumatology criteria
Recruitment from the Medical College of Virginia SLE registry
Location Information
W. Neal Roberts, Study Chair, Virginia Commonwealth University
More Information
Record last reviewed: December 2001
Last Updated: October 13, 2004
Record first received: February 24, 2000
ClinicalTrials.gov Identifier: NCT00004756
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 9, 2005
Resources
- Autoimmune Diseases (Cleveland Clinic)
- Lupus (HealthWorld)
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