Psychoeducational Approach to Improve Health in Lupus

NCT00000417 | Completed Phase 2

• 2 other identifiers: P60 AR36308 NIAMS-014P60AR036308
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Systemic Lupus Erythematosus

Keywords

SLE; Lupus; Educational intervention; Health education; Social support network; Outcomes research; Self-help

Interventions

Counseling intervention PROCEDURE

Informational film DEVICE

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Has partner willing to participate in study

You may not qualify if:

• 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

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS): collaborator

Study Sites (1)

Brigham & Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Related Publications (1)

• 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.

  PMID: 15188360 BACKGROUND

MeSH Terms

Conditions

Lupus Erythematosus, Systemic; Health Education

Interventions

Counseling

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Adherence Interventions; Medication Adherence; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Mental Health Services; Behavioral Disciplines and Activities; Community Health Services; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Lawren H. Daltroy, DrPH

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: November 3, 1999
• First Posted: November 4, 1999
• Study Start: April 1, 1997
• Primary Completion: March 1, 2001
• Study Completion: March 1, 2001
• Last Updated: December 24, 2013

Record last verified: 2013-12

Locations

US (1)