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Psychoeducational Approach to Improve Health in Lupus - Article


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Systemic Lupus Erythematosus

Sle 




Clinical Trial: Psychoeducational Approach to Improve Health in Lupus

This study has been completed.

Sponsored by: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Information provided by: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

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

MedlinePlus related topics:  Lupus

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)

Further Study Details: 

Expected Total Enrollment:  150

Study start: April 1997;  Study completion: March 2001

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   -   75 Years,  Genders Eligible for Study:  Both

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

Location Information


Massachusetts
      Brigham & Women's Hospital, Boston,  Massachusetts,  02115,  United States

Study chairs or principal investigators

Lawren H. Daltroy, DrPH,  Principal Investigator,  Brigham & Women's Hospital   

More Information

Publications

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.

Study ID Numbers:  NIAMS-014; P60 AR36308
Record last reviewed:  July 2004
Last Updated:  October 13, 2004
Record first received:  November 3, 1999
ClinicalTrials.gov Identifier:  NCT00000417
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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November 28, 2009



Page Updated: October 15, 2009
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