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Chronic Disease Self-Management Program for Systemic Lupus Erythematosus (WELL Trial)
N/A
Waitlist Available
Led By Cristina M Drenkard, MD, PhD
Research Sponsored by Emory University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
WELL Trial Summary
This trial will study whether the CDSMP can help African American women with SLE to better manage their condition and improve their health outcomes.
Who is the study for?
This study is specifically for African American women who are already part of the GOAL study and have systemic lupus erythematosus (SLE). It's not open to those who've done the Chronic Disease Self-Management Program in the last five years or have significant cognitive impairment.Check my eligibility
What is being tested?
The trial is testing if a program called Chronic Disease Self-Management Program can help improve health outcomes and reduce healthcare usage for African American women with SLE, as it hasn't been widely studied in this group before.See study design
What are the potential side effects?
Since CDSMP is an educational program rather than a medication, there aren't typical drug side effects. However, participants may experience stress or discomfort when discussing personal health issues.
WELL Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Communication With Physician - Stanford 3Q Scale Score
PROMIS Ability to Participate in Social Roles and Activities Score
PROMIS Anxiety Score
+7 moreSecondary outcome measures
Emergency Department Visit Rate
Hospitalization Rate
Number of Participants at Each Activation Level of the Patient Activation Measure (PAM-10)
+3 moreWELL Trial Design
2Treatment groups
Active Control
Group I: Chronic Disease Self-management Program (CDSMP)Active Control1 Intervention
A random sample of African American women with SLE selected from the Georgians Organized Against Lupus (GOAL) parent cohort will be used to recruit participants into the CDSMP. This group will be identified as the WELL Cohort.
Group II: Usual CareActive Control1 Intervention
African American women consented into the parent Georgians Organized Against Lupus (GOAL) cohort who have not been selected to be enrolled in the intervention will comprise the usual care group. This group will continue their longitudinal assessments as part or the GOAL cohort data collection efforts.
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Who is running the clinical trial?
Emory UniversityLead Sponsor
1,636 Previous Clinical Trials
2,559,874 Total Patients Enrolled
National Institute on Minority Health and Health Disparities (NIMHD)NIH
380 Previous Clinical Trials
1,214,955 Total Patients Enrolled
Centers for Disease Control and PreventionFED
875 Previous Clinical Trials
22,476,703 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have significant difficulties with my memory or thinking.
Research Study Groups:
This trial has the following groups:- Group 1: Chronic Disease Self-management Program (CDSMP)
- Group 2: Usual Care
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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