Peer Approaches to Lupus Self-management

NCT03734055 | Active Not Recruiting Results

• 2 other identifiers: Pro000808751R01NR017892-01A1
• Study Type: interventional
• Target: 314
• Locations: 1 country
• Sites: 1

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.

Conditions

Systemic Lupus Erythematosus; Quality of Life; Behavior, Health

Outcome Measures

Primary Outcomes (2)

• Satisfaction in Quality of Life as Assessed by the LUP-QOL (Lupus Quality of Life Questionnaire

  Quality of life will be assessed by using The LUP-QOL (Lupus Quality of Life Questionnaire), which assesses areas of the participant's life that may be affected by lupus. The score ranges from 0-100. A score of '0' indicates the lowest quality of life, and a score of 100 indicates the best quality of life. The 'Overall Impact' field reported has a scale of 0-700. Higher values represent a better outcome.

  Baseline to 12 months post-intervention

• Change in Self-management

  The Patient Activation Measure (PAM) assesses an individual's knowledge, skill, and confidence for managing their health and healthcare. Individuals who measure high on this assessment typically understand the importance of taking a proactive role in managing their health and have the skills and confidence to do so. The PAM survey measures patients on a 0-100 scale and can segment patients into one of four activation levels along an empirically derived continuum, including "Believes Active Role Important", "Confidence and Knowledge to Take Action", "Taking Action", and "Staying Course Under Stress". Each activation level reveals insight into an array of health-related characteristics, including attitudes, motivators, behaviors, and outcomes. A high score represents a better outcome.

  Baseline to 12 months post-intervention

Secondary Outcomes (3)

• Treatment Credibility

  Baseline to 12 months post-intervention

• Satisfaction With Care: Validated General Scale

  Baseline to 12 months post-intervention

• Disease Activity Measured by the Systemic Lupus Activity Questionnaire (SLAQ)

  Baseline to 12 months post-intervention

Study Arms (3)

Peer Mentoring

EXPERIMENTAL

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.

Behavioral: Peer Mentoring

Social Support Group

ACTIVE COMPARATOR

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

Behavioral: Social Support Group

Peer Mentors

NO INTERVENTION

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.

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.

Peer Mentoring

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.

Social Support Group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• African American race/ethnicity
• Female sex
• Clinical diagnosis of SLE from a physician, according to ACR revised criteria for SLE
• years of age or older
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medical University of South Carolina: lead
• National Institute of Nursing Research (NINR): collaborator

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Related Publications (2)

• Leung J, Keller EP, Nietert P, Caldwell T, Dismuke-Greer CL, Johnson H, Williams E. Does social support reduce bodily pain among African American women with SLE? Findings from a randomised controlled trial. Lupus Sci Med. 2025 Oct 20;12(2):e001712. doi: 10.1136/lupus-2025-001712.

  PMID: 41120192 DERIVED

• 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.

  PMID: 31443732 DERIVED

MeSH Terms

Conditions

Lupus Erythematosus, Systemic; Health Behavior

Interventions

Self-Help Groups

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Behavior

Intervention Hierarchy (Ancestors)

Organizations; Health Care Economics and Organizations

Results Point of Contact

• Title: Dr. Edith Williams
• Organization: University of Rochester

edith_williams@urmc.rochester.edu

5856020802

Study Officials

• Edith Williams, PhD

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 26, 2018
• First Posted: November 7, 2018
• Study Start: November 30, 2018
• Primary Completion: April 23, 2023
• Study Completion (Estimated): June 30, 2026
• Last Updated: August 20, 2025
• Results First Posted: August 20, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)