Psychoeducational Approach to Improve Health in Lupus

NCT ID: NCT00000417

Last Updated: 2013-12-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1997-04-30
• Study Completion Date: 2001-03-31

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.

Conditions

Systemic Lupus Erythematosus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Counseling intervention

Intervention Type: PROCEDURE

Informational film

Intervention Type: DEVICE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

NIH

Sponsor Role: collaborator

Brigham and Women's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Matthew H. Liang, MD

Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lawren H. Daltroy, DrPH

Role: PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital

Locations

Brigham & Women's Hospital

Boston, Massachusetts, United States

Countries

United States

References

Karlson EW, Liang MH, Eaton H, Huang J, Fitzgerald L, Rogers MP, Daltroy LH. A randomized clinical trial of a psychoeducational intervention to improve outcomes in systemic lupus erythematosus. Arthritis Rheum. 2004 Jun;50(6):1832-41. doi: 10.1002/art.20279.

Reference Type: BACKGROUND

PMID: 15188360 (View on PubMed)

Other Identifiers

P60AR036308

Identifier Type: NIH

Identifier Source: secondary_id

View Link

P60 AR36308 NIAMS-014

Identifier Type: -

Identifier Source: org_study_id