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Trial NCT00000417

Resource URI: http://static.linkedct.org/resource/trials/NCT00000417
PropertyValue
linkedct:brief_title Psychoeducational Approach to Improve Health in Lupus
linkedct:condition <http://static.linkedct.org/resource/condition/12793>
linkedct: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
linkedct:description 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.
linkedct:download_date Information obtained from ClinicalTrials.gov on December 30, 2009
linkedct:eligibility_gender Both
linkedct:eligibility_healthy_volunteers No
linkedct:eligibility_maximum_age 75 Years
linkedct:eligibility_minimum_age 18 Years
linkedct:end_date March 2001
linkedct:enrollment 150 (xsd:int)
linkedct:firstreceived_date November 3, 1999
linkedct:id NCT00000417
rdfs:label Trial NCT00000417
linkedct:lastchanged_date January 3, 2007
linkedct:lead_sponsor_agency National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
linkedct:location <http://static.linkedct.org/resource/location/147577>
linkedct:nct_id NCT00000417
linkedct:number_of_arms 0 (xsd:int)
linkedct:number_of_groups 0 (xsd:int)
linkedct:official_title A Randomized Controlled Trial of a Psychoeducational Intervention to Improve Outcomes in Systemic Lupus Erythematosus (SLE)
linkedct:org_study_id P60 AR36308 NIAMS-014
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/34476>
linkedct:overall_status Completed
linkedct:oversight <http://static.linkedct.org/resource/oversight/2918>
foaf:page <http://clinicaltrials.gov/show/NCT00000417>
linkedct:phase Phase 2
linkedct:reference <http://static.linkedct.org/resource/reference/22593>
linkedct:source National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
linkedct:start_date April 1997
linkedct:study_design Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study
linkedct:study_type Interventional
linkedct:summary 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.
rdf:type linkedct:trials
linkedct:verification_date July 2004