Ignite Creation Date:
2024-05-05 @ 4:55 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00342095
Status:
COMPLETED
Last Update Posted:
2017-07-02
First Post:
2006-06-19
Brief Title:
Hormonal and Environmental Risk Factors for Developing Systemic Lupus Erythematosus The Carolina Lupus CLU Study
Sponsor:
National Institute of Environmental Health Sciences NIEHS
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Hormonal and Environmental Risk Factors for Developing Systemic Lupus Erythematosus The Carolina Lupus Study CLU and Disease Progression and Activity in the Carolina Lupus Study
Status:
COMPLETED
Status Verified Date:
2007-03-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Systemic lupus erythematosus SLE is severe chronic disabling autoimmune disease that significantly affects health status and quality of life Since the disease occurs most often in young to middle-aged adults SLE can also affect work and disability However there is currently little information on work-related disability from longitudinal population-based studies of SLE
Participants were enrolled into the Carolina Lupus Study between February 1997 and July 1999 We plan to conduct two telephone contacts with patients and one telephone contact with controls in a follow-up study to be conducted in 2001 The first patient contact will follow an introductory letter that describes the follow-up study This letter provides participants the opportunity via a toll-free phone number to decline further contact about this study The first patient contact will be a short 5 minute interview in which we determine their current source of lupus-related medical care timing of next expected visit and update contact information The second contact will involve a 60-minute telephone interview covering medical care utilization current health status including a patient-administered measure of lupus activity work and disability issues psychosocial attributes eg helplessness social support daily stressors including race-related issues and changes in exposures since the initial interview We will attempt to schedule the patients interviews within 3 months before or after the patient sees his or her own physician for SLE-related evaluation or treatment A short 15 minutes or less telephone interview will be conducted with controls focusing on current health work status and daily stresso
Ddisease damage will be assessed using the System Lupus international Collaborating Clinics SLICCAmerican College of Rheumatology ACR Damage Index a standardized and validated instrument that is completed by the patients physician
We will seek death certificates for patients and controls who have died in order to obtain cause of death information Next-of-kin information from death certificates will not be used
This study will allow up to determine the feasibility of obtaining reliable data on disease damage from more than 50 physicians involved in the treatment of patients in the Carolina Lupus Study This developmental work is a necessary foundation for any additional follow-up studies of the Carolina Lupus Study cohort We will also be able to examine associations with disability in patients and in controls and to examine the contribution of various factors to the increased disease severity experience by African-American SLE patients
Participants were enrolled into the Carolina Lupus Study between February 1997 and July 1999 We plan to conduct two telephone contacts with patients and one telephone contact with controls in a follow-up study to be conducted in 2001 The first patient contact will follow an introductory letter that describes the follow-up study This letter provides participants the opportunity via a toll-free phone number to decline further contact about this study The first patient contact will be a short 5 minute interview in which we determine their current source of lupus-related medical care timing of next expected visit and update contact information The second contact will involve a 60-minute telephone interview covering medical care utilization current health status including a patient-administered measure of lupus activity work and disability issues psychosocial attributes eg helplessness social support daily stressors including race-related issues and changes in exposures since the initial interview We will attempt to schedule the patients interviews within 3 months before or after the patient sees his or her own physician for SLE-related evaluation or treatment A short 15 minutes or less telephone interview will be conducted with controls focusing on current health work status and daily stresso
Ddisease damage will be assessed using the System Lupus international Collaborating Clinics SLICCAmerican College of Rheumatology ACR Damage Index a standardized and validated instrument that is completed by the patients physician
We will seek death certificates for patients and controls who have died in order to obtain cause of death information Next-of-kin information from death certificates will not be used
This study will allow up to determine the feasibility of obtaining reliable data on disease damage from more than 50 physicians involved in the treatment of patients in the Carolina Lupus Study This developmental work is a necessary foundation for any additional follow-up studies of the Carolina Lupus Study cohort We will also be able to examine associations with disability in patients and in controls and to examine the contribution of various factors to the increased disease severity experience by African-American SLE patients
Detailed Description:
Systemic lupus erythematosus SLE is severe chronic disabling autoimmune disease that significantly affects health status and quality of life Since the disease occurs most often in young to middle-aged adults SLE can also affect work and disability However there is currently little information on work-related disability from longitudinal population-based studies of SLE
Disease damage will be assessed using the System Lupus international Collaborating Clinics SLICCAmerican College of Rheumatology ACR Damage Index a standardized and validated instrument that is completed by the patients physician
This study will allow us to determine the feasibility of obtaining reliable data on disease damage from more than 50 physicians involved in the treatment of patients in the Carolina Lupus Study This developmental work is a necessary foundation for any additional follow-up studies of the Carolina Lupus Study cohort We will also be able to examine associations with disability in patients and in controls and to examine the contribution of various factors to the increased disease severity experience by African-American SLE patients
Disease damage will be assessed using the System Lupus international Collaborating Clinics SLICCAmerican College of Rheumatology ACR Damage Index a standardized and validated instrument that is completed by the patients physician
This study will allow us to determine the feasibility of obtaining reliable data on disease damage from more than 50 physicians involved in the treatment of patients in the Carolina Lupus Study This developmental work is a necessary foundation for any additional follow-up studies of the Carolina Lupus Study cohort We will also be able to examine associations with disability in patients and in controls and to examine the contribution of various factors to the increased disease severity experience by African-American SLE patients
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| OH97-E-N002 | None | None | None |