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Psychoeducational Approach to Improve Health in Lupus
This study has been completed.
First Received: November 3, 1999   Last Updated: January 3, 2007   History of Changes
Sponsor: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Information provided by: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
ClinicalTrials.gov Identifier: NCT00000417
  Purpose

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.


Condition Intervention Phase
Systemic Lupus Erythematosus
Procedure: Counseling intervention
Device: Informational film
Phase II

Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study
Official Title: A Randomized Controlled Trial of a Psychoeducational Intervention to Improve Outcomes in Systemic Lupus Erythematosus (SLE)

Resource links provided by NLM:


Further study details as provided by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS):

Estimated Enrollment: 150
Study Start Date: April 1997
Estimated Study Completion Date: March 2001
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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00000417

Locations
United States, Massachusetts
Brigham & Women's Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Investigators
Principal Investigator: Lawren H. Daltroy, DrPH Brigham and Women's Hospital
  More Information

Publications:
Study ID Numbers: P60 AR36308 NIAMS-014
Study First Received: November 3, 1999
Last Updated: January 3, 2007
ClinicalTrials.gov Identifier: NCT00000417     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS):
SLE
Lupus
Educational intervention
Health education
Social support network
Outcomes research
Self-help

Additional relevant MeSH terms:
Autoimmune Diseases
Immune System Diseases
Lupus Erythematosus, Systemic
Connective Tissue Diseases

ClinicalTrials.gov processed this record on November 27, 2009