Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Behavior, Health
  • Quality of Life
  • Systemic Lupus Erythematosus
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Health Services Research

Participation Requirements

Age
Between 18 years and 125 years
Gender
Only males

Description

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 Americ...

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.

Tracking Information

NCT #
NCT03734055
Collaborators
National Institute of Nursing Research (NINR)
Investigators
Principal Investigator: Edith Williams, PhD Medical University of South Carolina