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Study of Individualized Instruction Versus Pamphlet in Systemic Lupus Erythematosus

Primary Purpose

Systemic Lupus Erythematosus

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Tailored educational program
Educational materials
Sponsored by
National Center for Research Resources (NCRR)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional educational/counseling/training trial for Systemic Lupus Erythematosus focused on measuring arthritis & connective tissue diseases, disease-related problem/condition, educational needs, immunologic disorders and infectious disorders, rare disease, systemic lupus erythematosus

Eligibility Criteria

0 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    February 24, 2000
    Last Updated
    June 23, 2005
    Sponsor
    National Center for Research Resources (NCRR)
    Collaborators
    Virginia Commonwealth University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00004756
    Brief Title
    Study of Individualized Instruction Versus Pamphlet in Systemic Lupus Erythematosus
    Official Title
    Randomized Study of Individualized Instruction Versus Pamphlet in Systemic Lupus Erythematosus
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2001
    Overall Recruitment Status
    Completed
    Study Start Date
    December 1994 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    National Center for Research Resources (NCRR)
    Collaborators
    Virginia Commonwealth University

    4. Oversight

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Systemic Lupus Erythematosus
    Keywords
    arthritis & connective tissue diseases, disease-related problem/condition, educational needs, immunologic disorders and infectious disorders, rare disease, systemic lupus erythematosus

    7. Study Design

    Primary Purpose
    Educational/Counseling/Training
    Study Phase
    Not Applicable
    Allocation
    Randomized
    Enrollment
    150 (false)

    8. Arms, Groups, and Interventions

    Intervention Type
    Procedure
    Intervention Name(s)
    Tailored educational program
    Intervention Type
    Procedure
    Intervention Name(s)
    Educational materials

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    0 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    PROTOCOL ENTRY CRITERIA: Confirmed systemic lupus erythematosus (SLE) using American College of Rheumatology criteria Recruitment from the Medical College of Virginia SLE registry
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    W. Neal Roberts
    Organizational Affiliation
    Virginia Commonwealth University
    Official's Role
    Study Chair

    12. IPD Sharing Statement

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    Study of Individualized Instruction Versus Pamphlet in Systemic Lupus Erythematosus

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