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 : February 6, 2020
|Condition or disease||Intervention/treatment||Phase|
|Systemic Lupus Erythematosus Quality of Life Behavior, Health||Behavioral: Peer Mentoring Behavioral: Social Support Group||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||300 participants|
|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|
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.
- 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.
- 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.
- 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.
- 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
- 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).
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
|Contact: Edith Williams, PhDfirstname.lastname@example.org|
|United States, South Carolina|
|Medical University of South Carolina||Recruiting|
|Charleston, South Carolina, United States, 29425|
|Contact: Edith M Williams, PhD 843-876-1519 email@example.com|
|Principal Investigator: Edith M Williams, PhD|
|Principal Investigator:||Edith Williams, PhD||Medical University of South Carolina|