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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01NR017892-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Nursing Research (NINR) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment Credibility | 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 | Baseline to 12 months post-intervention |
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Inclusion Criteria:
Additional inclusion criteria for mentors include:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Edith Williams, PhD | Medical University of South Carolina | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41120192 | Derived | 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. | |
| 31443732 | 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. |
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IPD will not be available. All findings will be reported in aggregate terms.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Peer mentors administered the peer mentoring intervention and were not involved in social support groups.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline to 12 months post-intervention |
|
5 years
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Edith Williams | University of Rochester | 5856020802 | edith_williams@urmc.rochester.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 31, 2024 | Dec 31, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D008180 | Lupus Erythematosus, Systemic |
| D015438 | Health Behavior |
| ID | Term |
|---|---|
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D012657 | Self-Help Groups |
| ID | Term |
|---|---|
| D009938 | Organizations |
| D004472 | Health Care Economics and Organizations |
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| 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. |
|
| Satisfaction With Care: Validated General Scale | 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). | Baseline to 12 months post-intervention |
| Disease Activity Measured by the Systemic Lupus Activity Questionnaire (SLAQ) | 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. | Baseline to 12 months post-intervention |
| BG001 | 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. |
| BG002 | Mentors | Peer mentors administered the peer mentoring intervention and were not involved in social support groups. |
| BG003 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| OG001 | 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. |
|
|
| 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. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline to 12 months post-intervention |
|
|
|
| Secondary | Treatment Credibility | 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 | Not Posted | Jun 2026 | Baseline to 12 months post-intervention | Participants |
| Secondary | Satisfaction With Care: Validated General Scale | 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). | Not Posted | Jun 2026 | Baseline to 12 months post-intervention | Participants |
| Secondary | Disease Activity Measured by the Systemic Lupus Activity Questionnaire (SLAQ) | 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. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline to 12 months post-intervention |
|
|
|
| 0 |
| 122 |
| 0 |
| 122 |
| 0 |
| 122 |
| EG001 | 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. | 0 | 129 | 0 | 129 | 0 | 129 |
| EG002 | Peer Mentoring: Peer Mentors | Peer mentors administered the peer mentoring intervention and were not involved in social support groups. | 0 | 44 | 0 | 44 | 0 | 44 |
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| D001519 | Behavior |