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Peer Approaches to Lupus Self-management (PALS)

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ClinicalTrials.gov Identifier: NCT03734055
Recruitment Status : Recruiting
First Posted : November 7, 2018
Last Update Posted : January 4, 2019
Sponsor:
Collaborator:
National Institute of Nursing Research (NINR)
Information provided by (Responsible Party):
Medical University of South Carolina

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.

Condition or disease Intervention/treatment Phase
Systemic Lupus Erythematosus Quality of Life Behavior, Health Behavioral: Peer Mentoring Behavioral: Social Support Group Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Peer Approaches to Lupus Self-management
Actual Study Start Date : November 30, 2018
Estimated Primary Completion Date : June 30, 2023
Estimated Study Completion Date : September 25, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.
Behavioral: 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.

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




Primary Outcome Measures :
  1. Satisfaction in Quality of Life as assessed by the LUP-QOL (Lupus Quality of Life Questionnaire [ Time Frame: 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.

  2. Satisfaction in Quality of Life as assessed by the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Measurement System [ Time Frame: Baseline to 12 months post-intervention ]
    The Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) survey is a 13-question subset of the 41-question Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) questionnaire, with each question having 5 possible answers (not at all; a little bit; somewhat; quite a bit; very much), scored as 0, 1, 2, 3, or 4, respectively. The full range of FACIT-Fatigue scores is from 0 to 52. Higher scores are considered good, better, or healthy, and increasingly lower scores are considered to indicate greater fatigue.

  3. Change in Self-management [ Time Frame: 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.


Secondary Outcome Measures :
  1. Treatment Credibility [ Time Frame: 24 weeks 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

  2. Satisfaction with care: validated general scale [ Time Frame: 24 weeks 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).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03734055


Contacts
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Contact: Edith Williams, PhD 843-876-1519 wiled@musc.edu

Locations
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United States, South Carolina
Medical University of South Carolina Recruiting
Charleston, South Carolina, United States, 29425
Contact: Edith M Williams, PhD    843-876-1519    wiled@musc.edu   
Principal Investigator: Edith M Williams, PhD         
Sponsors and Collaborators
Medical University of South Carolina
National Institute of Nursing Research (NINR)
Investigators
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Principal Investigator: Edith Williams, PhD Medical University of South Carolina

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT03734055     History of Changes
Other Study ID Numbers: Pro00080875
R01NR017892 ( U.S. NIH Grant/Contract )
First Posted: November 7, 2018    Key Record Dates
Last Update Posted: January 4, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: IPD will not be available. All findings will be reported in aggregate terms.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases