NCT00004756

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 1994

Completed
5.2 years until next milestone

First Submitted

Initial submission to the registry

February 24, 2000

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 25, 2000

Completed
Last Updated

June 24, 2005

Status Verified

December 1, 2001

First QC Date

February 24, 2000

Last Update Submit

June 23, 2005

Conditions

Systemic Lupus Erythematosus

Keywords

arthritis & connective tissue diseasesdisease-related problem/conditioneducational needsimmunologic disorders and infectious disordersrare diseasesystemic lupus erythematosus

Interventions

Tailored educational programPROCEDURE
Educational materialsPROCEDURE

Eligibility Criteria

Age0 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
PROTOCOL ENTRY CRITERIA: Confirmed systemic lupus erythematosus (SLE) using American College of Rheumatology criteria Recruitment from the Medical College of Virginia SLE registry

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

MeSH Terms

Conditions

Lupus Erythematosus, SystemicArthritisConnective Tissue DiseasesImmune System DiseasesCommunicable DiseasesRare Diseases

Condition Hierarchy (Ancestors)

Skin and Connective Tissue DiseasesAutoimmune DiseasesJoint DiseasesMusculoskeletal DiseasesInfectionsDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • W. Neal Roberts

    Virginia Commonwealth University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Purpose
ECT
Sponsor Type
NIH

Study Record Dates

First Submitted

February 24, 2000

First Posted

February 25, 2000

Study Start

December 1, 1994

Last Updated

June 24, 2005

Record last verified: 2001-12