Psychoeducational Approach to Improve Health in Lupus

Phase 2

Completed

• Conditions: Systemic Lupus Erythematosus

• Registration Number: NCT00000417
• Lead Sponsor: Brigham and Women's Hospital

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 1997-04
• Study First Submitted: 1999-11-03
• Study First Submitted QC: 1999-11-03
• Study First Posted: 1999-11-04
• Primary Completion: 2001-03
• Study Completion: 2001-03
• Status Verified: 2013-12
• Last Update Submitted: 2013-12-23
• Last Update Posted: 2013-12-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Trial Locations

Locations (1)

Brigham & Women's Hospital; 🇺🇸 Boston, Massachusetts, United States