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Home > "P" Clinical Trials Conditions > Psychoeducational Approach to Improve Health in Lupus  Psychoeducational Approach to Improve Health in Lupus
Psychoeducational Approach to Improve Health in Lupus
For Condition: Systemic Lupus Erythematosus
Status: Completed
Sponsor(s): National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) ,
Synopsis: We will study the relationships among patient/partner communication, social support, and self-efficacy (a person's belief in the ability to manage his or her disease) as they affect the health of people with systemic lupus erythematosus (SLE, or lupus) over time. We are assigning 150 people with lupus and their partners to either (1) receive counseling to improve self-efficacy, partner support, and patient/partner problem solving or (2) see an informational film about lupus. We will follow study participants for 12 months to find out about their physical and mental health, disease activity, beliefs that they can take steps that help them feel better, coping, social support, and couples communication.
Details: Studies have shown that patient self-efficacy in disease management and social support predict physical and mental health and disease activity in lupus. We wished to study the relationships among patient/partner communication, social support, and self-efficacy as they influence patient health longitudinally. We are randomizing 150 lupus patients and their partners to either (1) participate in a counseling intervention to improve self-efficacy, partner support, and patient/partner problem-solving in lupus management or (2) see an informational film about lupus (control). The counseling intervention includes an initial in-person session followed by five monthly telephone calls to monitor and reinforce problem-solving. We will follow patients for 12 months for self-reported physical and mental health, disease activity, self-efficacy, coping, social support, and couples communication.
Eligibility:
Study Type: Interventional, Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study
Minimum Age/Maximum Age: 18 Years/75 Years
Genders: Both
Protocol Entry Criteria: Inclusion Criteria: - Has partner willing to participate in study Exclusion Criteria: - Unable to read and write English questionnaires - Unable to be reached by phone - Rheumatologist considers patient unable to participate, generally due to patient cognitive problems or severe illness
Total Enrollment: 150
Location and Contact Information:
Overall Study Official:
LawrenDaltroy, Principal Investigator, Brigham & Women's Hospital
Brigham & Women's Hospital
Boston, Massachusetts, 02115
United States
Additional Information:
Study ID Numbers: NIAMS-014; P60 AR36308
Study Start Date: April 1997
Record last reviewed: February 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000417
Other Systemic Lupus Erythematosus Studies:
1. Study of the Predictors of the Course and Early Outcome of Patients With Systemic Lupus Erythematosus: Nature Versus Nurture
2. Prevention of Atherosclerosis and Heart Disease in Patients with Systemic Lupus Erythematosis (SLE)
3. Humanized LL2IGG to Treat Systemic Lupus Erythematosus
4. Autologous Peripheral Blood Stem Cell Transplantation in Patients With Life Threatening Autoimmune Diseases
5. Psychoeducational Approach to Improve Health in Lupus
Related Studies:
Other Systemic Lupus Erythematosus Clinical Trials
Other Massachusetts Clinical Trials
Other Boston Clinical Trials
Psychoeducational Approach to Improve Health in Lupus
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