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Peer Support for Lupus (PALS Trial)

N/A

Waitlist Available

Led By Edith Williams, PhD

Research Sponsored by Medical University of South Carolina

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Female sex

18 years of age or older

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to 12 months post-intervention

Awards & highlights

No Placebo-Only Group

Summary

This trial is investigating whether a peer mentoring intervention can help African American women with lupus manage their condition.

Who is the study for?

This trial is for African American women over 18 with lupus (SLE), diagnosed by a doctor, who've had the disease for more than 2 years. They should be willing to support others with SLE and can attend training sessions. Women who were mentees in the pilot study can't join as mentees again but may qualify as mentors.

What is being tested?

The PALS study tests if peer mentoring helps manage lupus better. Participants are randomly chosen to either get phone calls from trained peers every two weeks or join a social support group, both lasting six months, with follow-ups until one year.

What are the potential side effects?

Since this trial involves peer mentoring and social support rather than medication, there aren't typical drug side effects. However, participants might experience emotional distress or discomfort sharing personal health information.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am female.

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I am 18 years old or older.

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I have been diagnosed with lupus by a doctor.

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My condition has been diagnosed for over 2 years.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to 12 months post-intervention

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to 12 months post-intervention

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 12 months post-intervention for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Self-management

Satisfaction in Quality of Life as assessed by the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Measurement System

Satisfaction in Quality of Life as assessed by the LUP-QOL (Lupus Quality of Life Questionnaire

Secondary study objectives

Satisfaction with care: validated general scale

Treatment Credibility

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Peer MentoringExperimental Treatment1 Intervention

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.

Group II: Social Support GroupActive Control1 Intervention

Mentees randomized to the social support control group will be enrolled in a lupus support group designed specifically for this project.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Peer Mentoring

2017

N/A

~1070

0 / 4Eligibility criteria met