Peer Approaches to Lupus Self-management

Part of paid clinical trials in Charleston, South Carolina.

Sponsor
Medical University of South Carolina
Study ID
NCT03734055
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Peer Mentoring — BEHAVIORAL
    Manualized peer mentorship program designed to provide modeling and reinforcement by peers (mentors) to other African American women with SLE (mentees) to encourage them to engage in activities that promote disease self-management.
  • Social Support Group — BEHAVIORAL
    Social support controls will participate in a lupus support group created for this project, on the same schedule as peer mentoring sessions.

Study Details

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.

Key Dates

Start date
Nov 30, 2018
Status verified
Aug 2025
Primary completion
Apr 23, 2023
Completion
Jun 30, 2026

Study Design

Enrollment
314 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • Experimental: Peer Mentoring
    The program will consist of 12 sessions of peer mentoring that will include one standard educational session by telephone or video for approximately 60 minutes every 2 weeks. Additional interaction will be discouraged, but mentees and mentors will be asked to report any additional social interaction should it occur. The bi-weekly educational session will be generally structured in three parts: introduction, structured education, and problem solving. 60-minute calls are necessary for the delivery of educational content and mentors and mentees to be able to discuss their own experiences and potential solutions.
  • Active Comparator: Social Support Group
    Mentees randomized to the social support control group will be enrolled in a lupus support group designed specifically for this project.
  • No Intervention: Peer Mentors
    The principal roles of the peer mentors are to: 1) provide information about SLE, SLE-related behaviors, thoughts, and feelings, and the nature of recommended treatments; 2) provide social support to alleviate the mentee's sense of social isolation; 3) enhance and reinforce the mentee's sense of self-efficacy to manage their condition; and 4) encourage the mentee to participate actively in the recommended self-management skills building therapy.

Primary Outcome Measure

Satisfaction in Quality of Life as Assessed by the LUP-QOL (Lupus Quality of Life Questionnaire [ Time Frame: Baseline to 12 months post-intervention ]

Locations (1)

FacilityCityStateZIPSite coordinators
Medical University of South CarolinaCharlestonSouth Carolina29425-

Find similar trials in Charleston, SC

By condition
Lupus (SLE)
By specialty
RheumatologyAutoimmune disease
By research site
Medical University of South Carolina· Charleston, SC

Related Studies