Clinical trial NCT03734055: Peer Approaches to Lupus Self-management
Official title: Peer Approaches to Lupus Self-management
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Systemic Lupus Erythematosus
Quality of Life
Behavior, Health
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
First posted: 2018-11-07
Enrollment: 344
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Satisfaction in Quality of Life as assessed by the LUP-QOL (Lupus Quality of Life Questionnaire
timeFrame: Baseline to 12 months post-intervention
measure: Satisfaction in Quality of Life as assessed by the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Measurement System
timeFrame: Baseline to 12 months post-intervention
measure: Change in Self-management
timeFrame: Baseline to 12 months post-intervention
Secondary outcomes:
measure: Treatment Credibility
timeFrame: 24 weeks post-intervention
measure: Satisfaction with care: validated general scale
timeFrame: 24 weeks post-intervention
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
affiliation: Medical University of South Carolina
name: Edith Williams, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Williams EM, Egede L, Oates JC, Dismuke CL, Ramakrishnan V, Faith TD, Johnson H, Rose J. Peer approaches to self-management (PALS): comparing a peer mentoring approach for disease self-management in African American women with lupus with a social support control: study protocol for a randomized controlled trial. Trials. 2019 Aug 23;20(1):529. doi: 10.1186/s13063-019-3580-4.