Systemic Lupus ErythematosusNCT00004756
Study of Individualized Instruction Versus Pamphlet in Systemic Lupus Erythematosus
A study testing Tailored educational program and Educational materials in people with Systemic Lupus Erythematosus, run by National Center for Research Resources (NCRR).
Trial 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. Read more about this study
- Who is it for?
- Ages 0 years and older
- Conditions the study is for
- Systemic Lupus Erythematosus
- What is being tested?
- Tailored educational program and Educational materials
- Type of treatment
- Surgery or procedure
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- Dec 1994to not given
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
PROTOCOL ENTRY CRITERIA:
Confirmed systemic lupus erythematosus (SLE) using American College of Rheumatology criteria
Recruitment from the Medical College of Virginia SLE registry
About this study
Official title: Randomized Study of Individualized Instruction Versus Pamphlet in Systemic Lupus Erythematosus
OBJECTIVES:
- 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.
Read the 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
- Systemic Lupus Erythematosus
- Being tested
- Tailored educational program, Educational materials
- Keywords
- arthritis & connective tissue diseases, disease-related problem/condition, educational needs, immunologic disorders and infectious disorders, rare disease, systemic lupus erythematosus
- Medical subject headings
- Lupus Erythematosus, Systemic, Arthritis, Connective Tissue Diseases, Immune System Diseases, Communicable Diseases, Rare Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tailored educational programProcedure or surgery
Educational materialsProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2000 (estimated)
- Study startDec 1994
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic Lupus ErythematosusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Early clinical test
- Allocation
- Randomised
- Enrolment
- 150 participants
Sponsor and investigators
- Lead sponsor
- National Center for Research Resources (NCRR)
- Sponsor type
- US National Institutes of Health
- Collaborators
- Virginia Commonwealth University
- Investigators
- W. Neal Roberts, Study chair, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00004756
- Sponsor's protocol ID
- 199/11686
- Other IDs
- VCU-92123A
- Status last verified
- Dec 2001
- First submitted
- 24 Feb 2000
- Last updated
- 24 Jun 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Study of Individualized Instruction Versus Pamphlet in Systemic Lupus Erythematosus
- ClinicalTrials.gov ID
- NCT00004756
- Acronym / sponsor ID
- 199/11686
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants
- Lead sponsor
- National Center for Research Resources (NCRR)US National Institutes of Health
- Collaborators
- Virginia Commonwealth University
- Study start
- Dec 1994
- First posted
- 25 Feb 2000 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
OBJECTIVES:
- 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.
Study design
- Primary purpose
- Early clinical test
- Allocation
- Randomised
Who may qualify
- Ages
- 0 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tailored educational program | Procedure or surgery | – |
| Educational materials | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2005.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
W. Neal Roberts study chair
Virginia Commonwealth University
Questions about this trial
What is this clinical trial studying?
A study testing Tailored educational program and Educational materials in people with Systemic Lupus Erythematosus, run by National Center for Research Resources (NCRR).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2005. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2005.