|
Improving Quality of Life for African American Female Adolescents With Lupus Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment by using a genuine medical doctor. We aren't mDs. Always confer with your doctor on Improving Quality of Life for African American Female Adolescents With Lupus conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. Improving Quality of Life for African American Female Adolescents With Lupus Clinical research trials and Improving Quality of Life for African American Female Adolescents With Lupus healthcare trials occur in a lot of of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectivity of new does drugs. The role of the studies / undertakings is to solve specific human healthcare questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to find treatments for all kinds of conditions, including Improving Quality of Life for African American Female Adolescents With Lupus. Improving Quality of Life for African American Female Adolescents With Lupus Clinical Trials and other clinical trials allow for volunteers to access health treatment choices before they are available to the general public. Many times the test subjects get treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a Improving Quality of Life for African American Female Adolescents With Lupus clinical trial. Test subjects typically receive the most effective healthcare possible for their Improving Quality of Life for African American Female Adolescents With Lupus condition. Risks are a reality, nonetheless, and could include extra or frequent dr. calls, health hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.
|
|
|
|
|
|
|
Home > "I" Clinical Trials Conditions > Improving Quality of Life for African American Female Adolescents With Lupus  Improving Quality of Life for African American Female Adolescents With Lupus
Improving Quality of Life for African American Female Adolescents With Lupus
For Condition: Lupus
Status: Not yet recruiting
Sponsor(s): National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) ,
Synopsis: This study will evaluate a program designed to help African American adolescents with lupus (systemic lupus erythematosus or SLE) cope with the disease.
Details: SLE is the most common autoimmune connective tissue disease of childhood, affecting 5,000 to 10,000 children; the prevalence is higher among African American children and approximately 80% of sufferers are female. SLE is multisystemic in onset and has no known cure. Children with chronic illness have at least a two-fold increased risk for adjustment problems relative to their healthy peers. This risk is heightened among adolescents, who are at greater risk for psychopathology than are younger children. The diagnosis of a chronic medical condition during adolescence presents unique stressors, particularly for adolescents with lupus, who must endure bodily changes, including dermatological problems, hair loss, and changes in appearance due to medical therapies. Psychosocial processes, including methods of coping, expectations, and family functioning, are believed to mediate the influence of disease severity. This study will evaluate the effectiveness of a cognitive-based intervention to improve the quality of life of adolescents with SLE. Participants in this study will be randomly assigned to either the cognitive-based intervention, a lupus education program, or a control group. Participants in the intervention group will have five study visits over 5 months. The first three visits are biweekly, 45-minute sessions during which the adolescent will be taught coping skills and cognitive restructuring techniques. The coping skills training will include training in relaxation, distraction, and problem-solving skills. The cognitive restructuring techniques will assist adolescents in using more accurate and adaptive cognitive responses. Caregivers will join the adolescent at the end of each training session to gain familiarity with the content reviewed in each session. The remaining two study visits are booster sessions during which the intervention material will be reviewed. Participants in the education program will also have five study visits. Study visits will include disease-appropriate education materials. Caregivers will not be included in the education program. Participants will be assessed at study entry and Months 6, 9, and 12. Assessments will include questionnaires designed to measure disease severity, pain intensity, methods of coping, expectations of efficacy, social support, and adjustment.
Eligibility:
Study Type: Interventional, Treatment, Randomized, Single Blind, Placebo Control, Factorial Assignment, Efficacy Study
Minimum Age/Maximum Age: 12 Years/18 Years
Genders: Female
Protocol Entry Criteria: Inclusion Criteria - Diagnosis of systemic lupus erythematosus (SLE) Exclusion Criteria - Severe depression with suicidal thoughts - Delirium, dementia, or cognitive impairment (e.g., Mini Mental Status Examination =< 24) - Severe intellectual impairment - Terminal illness with a life expectancy of < 1 year
Total Enrollment: 120
Location and Contact Information:
Overall Study Official:
RonaldBrown, Principal Investigator, Medical University of South Carolina
Ronald T. Brown, PhD
Charleston, South Carolina, 29425
United States
Ronald Brown 843-792-2419
Additional Information:
Study ID Numbers: NIAMS-094; 1 P60 AR049459-01
Study Start Date:
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00068874
Other Lupus Studies:
1. Prevention of Atherosclerosis and Heart Disease in Patients with Systemic Lupus Erythematosis (SLE)
2. Improving Quality of Life for African American Female Adolescents With Lupus
3. To assess prevention of bone loss in women with lupus receiving treatment with glucocorticoids
Related Studies:
Other Lupus Clinical Trials
Other South Carolina Clinical Trials
Other Charleston Clinical Trials
Improving Quality of Life for African American Female Adolescents With Lupus
|
|
|
|
|
|
|
|
