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Sponsored by: |
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) |
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Information provided by: | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) |
ClinicalTrials.gov Identifier: | NCT00000417 |
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.
Condition | Intervention | Phase |
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Systemic Lupus Erythematosus |
Procedure: Counseling intervention Device: Informational film |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study |
Official Title: | A Randomized Controlled Trial of a Psychoeducational Intervention to Improve Outcomes in Systemic Lupus Erythematosus (SLE) |
Estimated Enrollment: | 150 |
Study Start Date: | April 1997 |
Estimated Study Completion Date: | March 2001 |
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.
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Massachusetts | |
Brigham & Women's Hospital | |
Boston, Massachusetts, United States, 02115 |
Principal Investigator: | Lawren H. Daltroy, DrPH | Brigham and Women's Hospital |
Study ID Numbers: | P60 AR36308 NIAMS-014 |
Study First Received: | November 3, 1999 |
Last Updated: | January 3, 2007 |
ClinicalTrials.gov Identifier: | NCT00000417 |
Health Authority: | United States: Federal Government |
SLE Lupus Educational intervention Health education |
Social support network Outcomes research Self-help |
Autoimmune Diseases Lupus Erythematosus, Systemic Connective Tissue Diseases |
Immune System Diseases |