Peer Approaches to Lupus Self-management (PALS)

Medical University of South Carolina (MUSC)

Status: Completed

Conditions: Quality of Life; Behavior, Health; Systemic Lupus Erythematosus

Treatments: Behavioral: Social Support Group; Behavioral: Peer Mentoring

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03734055

Pro00080875

1R01NR017892-01A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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 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.

Enrollment: 344 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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344 participants in 2 patient groups

Peer Mentoring

Experimental group

Description:

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.

Treatment:

Behavioral: Peer Mentoring

Social Support Group

Active Comparator group

Description:

Mentees randomized to the social support control group will be enrolled in a lupus support group designed specifically for this project.

Treatment:

Behavioral: Social Support Group