Peer Approaches to Lupus Self-management

Status

Active, not recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03734055

Acronym

PALS

Enrollment

314

Registered

2018-11-07

Start date

2018-11-30

Completion date

2026-06-30

Last updated

2025-08-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Systemic Lupus Erythematosus, Quality of Life, Behavior, Health

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.

Interventions

BEHAVIORALPeer Mentoring

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.

BEHAVIORALSocial Support Group

Social support controls will participate in a lupus support group created for this project, on the same schedule as peer mentoring sessions.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
Satisfaction in Quality of Life as Assessed by the LUP-QOL (Lupus Quality of Life Questionnaire	Baseline to 12 months post-intervention	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.
Change in Self-management	Baseline to 12 months post-intervention	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.

Secondary

Measure	Time frame	Description
Treatment Credibility	Baseline to 12 months post-intervention	To assess for differences in outcome expectancy, a modified treatment credibility scale developed by Borkovec and Nau (1972) will be used. Four of the questions will be used for this study, with 10-point Likert scales. These include questions regarding how logical the treatment seems, how confident participants are about treatment, and their expectancy of success
Satisfaction With Care: Validated General Scale	Baseline to 12 months post-intervention	Satisfaction with Care will be measured with a previously validated general scale to measure satisfaction/dissatisfaction with health care. The 2-item scale ranges from 1 (Strongly Agree) to 5 (Strongly Disagree).
Disease Activity Measured by the Systemic Lupus Activity Questionnaire (SLAQ)	Baseline to 12 months post-intervention	The Systemic Lupus Activity Questionnaire (SLAQ) asks a single Patient Global Assessment (PGA) question about presence and severity of lupus activity over the past month, questions on 24 specific symptoms of disease activity and a single Numerical Rating Scale (NRS) asking the patient to rate disease activity on a scale of 0-10 over the past three months. The reported patient global assessment has a scale of 0-3. A higher score represents a better outcome.

Countries

United States

Participant flow

Participants by arm

Arm	Count
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. Peer Mentoring: 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.	138
Social Support Group Mentees randomized to the social support control group will be enrolled in a lupus support group designed specifically for this project. Social Support Group: Social support controls will participate in a lupus support group created for this project, on the same schedule as peer mentoring sessions.	132
Mentors Peer mentors administered the peer mentoring intervention and were not involved in social support groups.	44
Total	314

Baseline characteristics

Characteristic	Peer Mentoring	Total	Mentors	Social Support Group
Age, Continuous	45 years STANDARD_DEVIATION 2.82	47 years STANDARD_DEVIATION 2.82	49 years STANDARD_DEVIATION 2.82	48 years STANDARD_DEVIATION 2.82
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants	0 Participants	0 Participants	0 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	138 Participants	314 Participants	44 Participants	132 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Asian	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Black or African American	138 Participants	314 Participants	44 Participants	132 Participants
Race (NIH/OMB) More than one race	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) White	0 Participants	0 Participants	0 Participants	0 Participants
Region of Enrollment United States	138 participants	314 participants	44 participants	132 participants
Sex: Female, Male Female	138 Participants	314 Participants	44 Participants	132 Participants
Sex: Female, Male Male	0 Participants	0 Participants	0 Participants	0 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk
deaths Total, all-cause mortality	0 / 122	0 / 129	0 / 44
other Total, other adverse events	0 / 122	0 / 129	0 / 44
serious Total, serious adverse events	0 / 122	0 / 129	0 / 44

Outcome results

Primary

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.