Peer Approaches to Lupus Self-management

Quality of Life Clinical Trial

— PALS  

Official title:

Peer Approaches to Lupus Self-management

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03734055
• Other study ID #: Pro00080875
• Secondary ID: R01NR017892
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 30, 2018
• Est. completion date: September 25, 2024

Study information

• Verified date: August 2023
• Source: Medical University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 344
• Est. completion date: September 25, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Behavior, Health
• Lupus Erythematosus, Systemic
• Quality of Life
• Systemic Lupus Erythematosus

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Medical University of South Carolina	Charleston	South Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Medical University of South Carolina	National Institute of Nursing Research (NINR)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	Baseline to 12 months post-intervention
Primary	Satisfaction in Quality of Life as assessed by the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Measurement System	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.	Baseline to 12 months post-intervention
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.	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	24 weeks post-intervention
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).	24 weeks post-intervention