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Psychoeducational Approach to Improve Health in Lupus

Primary Purpose

Systemic Lupus Erythematosus

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Counseling intervention
Informational film
Sponsored by
Brigham and Women's Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Systemic Lupus Erythematosus focused on measuring SLE, Lupus, Educational intervention, Health education, Social support network, Outcomes research, Self-help

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Brigham & Women's Hospital

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 3, 1999
Last Updated
December 23, 2013
Sponsor
Brigham and Women's Hospital
Collaborators
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
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1. Study Identification

Unique Protocol Identification Number
NCT00000417
Brief Title
Psychoeducational Approach to Improve Health in Lupus
Official Title
A Randomized Controlled Trial of a Psychoeducational Intervention to Improve Outcomes in Systemic Lupus Erythematosus (SLE)
Study Type
Interventional

2. Study Status

Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
April 1997 (undefined)
Primary Completion Date
March 2001 (Actual)
Study Completion Date
March 2001 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brigham and Women's Hospital
Collaborators
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

4. Oversight

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Systemic Lupus Erythematosus
Keywords
SLE, Lupus, Educational intervention, Health education, Social support network, Outcomes research, Self-help

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (false)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
Counseling intervention
Intervention Type
Device
Intervention Name(s)
Informational film

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lawren H. Daltroy, DrPH
Organizational Affiliation
Brigham and Women's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brigham & Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
15188360
Citation
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. doi: 10.1002/art.20279.
Results Reference
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Psychoeducational Approach to Improve Health in Lupus

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