Trial Outcomes & Findings for Peer Approaches to Lupus Self-management (NCT NCT03734055)
NCT ID: NCT03734055
Last Updated: 2025-08-20
Results Overview
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.
ACTIVE_NOT_RECRUITING
NA
314 participants
Baseline to 12 months post-intervention
2025-08-20
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
182
|
132
|
|
Overall Study
Mentors
|
44
|
0
|
|
Overall Study
Mentees
|
138
|
132
|
|
Overall Study
COMPLETED
|
161
|
129
|
|
Overall Study
NOT COMPLETED
|
21
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Peer Approaches to Lupus Self-management
Baseline characteristics by cohort
| Measure |
Peer Mentoring
n=138 Participants
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.
|
Social Support Group
n=132 Participants
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.
|
Mentors
n=44 Participants
Peer mentors administered the peer mentoring intervention and were not involved in social support groups.
|
Total
n=314 Participants
Total of all reporting groups
|
|---|---|---|---|---|
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Age, Continuous
|
45 years
STANDARD_DEVIATION 2.82 • n=99 Participants
|
48 years
STANDARD_DEVIATION 2.82 • n=107 Participants
|
49 years
STANDARD_DEVIATION 2.82 • n=206 Participants
|
47 years
STANDARD_DEVIATION 2.82 • n=7 Participants
|
|
Sex: Female, Male
Female
|
138 Participants
n=99 Participants
|
132 Participants
n=107 Participants
|
44 Participants
n=206 Participants
|
314 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
138 Participants
n=99 Participants
|
132 Participants
n=107 Participants
|
44 Participants
n=206 Participants
|
314 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Black or African American
|
138 Participants
n=99 Participants
|
132 Participants
n=107 Participants
|
44 Participants
n=206 Participants
|
314 Participants
n=7 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Region of Enrollment
United States
|
138 participants
n=99 Participants
|
132 participants
n=107 Participants
|
44 participants
n=206 Participants
|
314 participants
n=7 Participants
|
PRIMARY outcome
Timeframe: Baseline to 12 months post-interventionQuality 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.
Outcome measures
| Measure |
Peer Mentoring
n=122 Participants
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.
|
Social Support Group
n=129 Participants
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.
|
|---|---|---|
|
Satisfaction in Quality of Life as Assessed by the LUP-QOL (Lupus Quality of Life Questionnaire
|
330.50 units on a scale
Standard Error 15.76
|
332.34 units on a scale
Standard Error 15.75
|
PRIMARY outcome
Timeframe: Baseline to 12 months post-interventionThe 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.
Outcome measures
| Measure |
Peer Mentoring
n=122 Participants
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.
|
Social Support Group
n=129 Participants
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.
|
|---|---|---|
|
Change in Self-management
|
33.16 units on a scale
Standard Error 0.40
|
33.12 units on a scale
Standard Error 0.39
|
SECONDARY outcome
Timeframe: Baseline to 12 months post-interventionTo 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
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline to 12 months post-interventionSatisfaction 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).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline to 12 months post-interventionThe 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.
Outcome measures
| Measure |
Peer Mentoring
n=122 Participants
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.
|
Social Support Group
n=129 Participants
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.
|
|---|---|---|
|
Disease Activity Measured by the Systemic Lupus Activity Questionnaire (SLAQ)
|
1.13 units on a scale
Standard Error 0.08
|
1.19 units on a scale
Standard Error 0.08
|
Adverse Events
Peer Mentoring
Social Support Group
Peer Mentoring: Peer Mentors
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place