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Psychoeducational Approach to Improve Health in Lupus

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00000417
First Posted: November 4, 1999
Last Update Posted: December 24, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Information provided by (Responsible Party):
Matthew H. Liang, MD, Brigham and Women's Hospital
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Matthew H. Liang, MD, Brigham and Women's Hospital:

Estimated Enrollment: 150
Study Start Date: April 1997
Study Completion Date: March 2001
Primary Completion Date: March 2001 (Final data collection date for primary outcome measure)
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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00000417


Locations
United States, Massachusetts
Brigham & Women's Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Brigham and Women's Hospital
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Investigators
Principal Investigator: Lawren H. Daltroy, DrPH Brigham and Women's Hospital
  More Information

Publications:
Responsible Party: Matthew H. Liang, MD, Professor of Medicine, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT00000417     History of Changes
Other Study ID Numbers: P60 AR36308 NIAMS-014
P60AR036308 ( U.S. NIH Grant/Contract )
First Submitted: November 3, 1999
First Posted: November 4, 1999
Last Update Posted: December 24, 2013
Last Verified: December 2013

Keywords provided by Matthew H. Liang, MD, Brigham and Women's Hospital:
SLE
Lupus
Educational intervention
Health education
Social support network
Outcomes research
Self-help

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