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Psychoeducational Approach to Improve Health in Lupus

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ClinicalTrials.gov Identifier: NCT00000417
Recruitment Status : Completed
First Posted : November 4, 1999
Last Update Posted : December 24, 2013
Sponsor:
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

November 3, 1999
November 4, 1999
December 24, 2013
April 1997
March 2001   (Final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00000417 on ClinicalTrials.gov Archive Site
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Psychoeducational Approach to Improve Health in Lupus
A Randomized Controlled Trial of a Psychoeducational Intervention to Improve Outcomes in Systemic Lupus Erythematosus (SLE)
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.
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.
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Systemic Lupus Erythematosus
  • Procedure: Counseling intervention
  • Device: Informational film
Not Provided
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
150
Same as current
March 2001
March 2001   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00000417
P60 AR36308 NIAMS-014
P60AR036308 ( U.S. NIH Grant/Contract )
Not Provided
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Matthew H. Liang, MD, Brigham and Women's Hospital
Brigham and Women's Hospital
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Principal Investigator: Lawren H. Daltroy, DrPH Brigham and Women's Hospital
Brigham and Women's Hospital
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP