Peer Approaches to Lupus Self-management



Status:Recruiting
Conditions:Lupus
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - Any
Updated:1/6/2019
Start Date:November 30, 2018
End Date:September 25, 2023
Contact:Edith Williams, PhD
Email:wiled@musc.edu
Phone:843-876-1519

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The Peer Approaches to Lupus Self-Management (PALS) study is a randomized, controlled in
which 360 African American women with lupus will be recruited from the MUSC SLE database (60
mentors and 300 mentees). The peer mentoring intervention (patients will be matched with peer
mentors who are considered competent in the management of their condition to provide modeling
and reinforcement to participants) will occur by telephone for approximately 60 minutes every
two weeks for 24 weeks. All participants will be assessed at baseline, mid-intervention (12
weeks post-enrollment), immediately following the intervention (24 weeks post-enrollment),
and 12 months post-enrollment. The study will last 60 months with recruitment and enrollment
over 48 months, 6 months for intervention delivery and 6 months for data analysis.

The Peer Approaches to Lupus Self-Management (PALS) study is a randomized controlled trial
designed to examine whether a new, culturally tailored peer mentoring intervention improves
disease self-management, indicators of disease activity, and health related quality of life
(HRQOL) in African American women with systemic lupus erythematosus (SLE). African American
women with active SLE will be recruited as mentees and peer mentors. The investigators will
recruit 300 mentees (150 mentored and 150 support group) and up to 60 mentors. As part of
each wave, mentors (n=20) will be trained to deliver intervention content, prior to being
paired with up to three mentees (n=50). The peer mentoring intervention will occur by twelve
60-minute telephone or video sessions carried out across the course of 24 weeks. In each
wave, social support controls (n=50) will participate in a lupus support group created for
this project, on the same schedule as peer mentoring sessions. Both conditions will be
delivered via Webex, which has several advantages for this intervetion: 1) Sessions are
easily accesible via phone or computer, allowing participants to choose their preferred
interaction style; 2) A study coordinator can host the support groups and drop in/out for
monitoring purposes; 3) There are video- or voice-call options for up to 25 paricipants at a
time; and 4) This application ensures concordiant delivery methods across both arms of the
study and the ability to document the frequency that voice and video options are used to
adjust for participant choices in analyses. All participants (mentees, mentors, and social
support controls) will be assessed using validated measures of patient reported outcomes and
clinical indicators of disease activity at baseline, mid-intervention (3 months from
baseline), immediately post-intervention (6 months from baseline), and 6 months
post-intervention (12 months from baseline). For each wave, outcomes for mentees randomized
to the mentored group will be compared with the outcomes of mentees randomized to the support
group. A booster session will be incorporated for all participants (mentored and support
group) at 3 months post-intervention to encourage retention.

Inclusion Criteria:

- African American race/ethnicity

- Female sex

- Clinical diagnosis of SLE from a physician, according to ACR revised criteria for SLE

- 18 years of age or older

Additional inclusion criteria for mentors include:

- Disease duration > 2 years

- Able to attend scheduled training sessions

- Willing to provide one-on-one support to up to three African American women with SLE

Exclusion Criteria:

- Mentees who participated in the pilot will be ineligible to participate in this study
as a mentee, but could participate as a mentor if they meet other eligibility
criteria.
We found this trial at
1
site
171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
Principal Investigator: Edith M Williams, PhD
Phone: 843-876-1519
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
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Charleston, SC
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