Psychoeducational Approach to Improve Health in Lupus

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.

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Key information

Conditions

Systemic Lupus Erythematosus Adherence Interventions Autoimmune Diseases Behavior Connective Tissue Diseases Health Behavior Health Education Immune System Diseases Lupus Erythematosus, Systemic Medication Adherence Patient Acceptance of Health Care Patient Compliance Skin and Connective Tissue Diseases Treatment Adherence and Compliance

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Brigham & Women's Hospital

Boston, Massachusetts, 02115, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Counseling intervention

Procedure

Informational film

Device

Sponsors and collaborators

Lead sponsor

Brigham and Women's Hospital

Other

Collaborators

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

Registry information

Official study title

A Randomized Controlled Trial of a Psychoeducational Intervention to Improve Outcomes in Systemic Lupus Erythematosus (SLE)

Important dates

Study start: 1997
Primary completion: 2001
Study completion: 2001
First posted: Nov 4, 1999
Registry last updated: Dec 24, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed