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HOP-STEP Program for Lupus (HOP-STEPsIRB Trial)
N/A
Waitlist Available
Led By Megan E Clowse, MD
Research Sponsored by Duke University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
adult and/or pediatric clinical rheumatology providers within UCMC clinic
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up intervention period, up to 12 months
Awards & highlights
HOP-STEPsIRB Trial Summary
This trial seeks to fit and pilot an intervention to improve maternal outcomes at The University of Chicago Medical Center.
Who is the study for?
This trial is for clinical rheumatology providers at the University of Chicago Medical Center. It aims to improve maternal health in women with lupus by educating providers on pregnancy planning and contraception.Check my eligibility
What is being tested?
The HOP-STEP program, designed to boost provider confidence and ensure equitable care in pregnancy planning for lupus patients, is being tested against routine care practices to measure its effectiveness.See study design
What are the potential side effects?
Since this intervention focuses on education rather than medication or medical procedures, there are no direct side effects associated with it.
HOP-STEPsIRB Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowHOP-STEPsIRB Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ intervention period, up to 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~intervention period, up to 12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Contraception Documentation
Secondary outcome measures
Adoption: Providers that ever complete the HOP-STEP intervention
Degree of Adoption: Providers' completion of the HOP-STEP intervention
Effectiveness: ACR-aligned contraception
+9 moreHOP-STEPsIRB Trial Design
2Treatment groups
Experimental Treatment
Group I: Routine Care ProvidersExperimental Treatment1 Intervention
Care Providers in this arm will continue seeing patients as normal in clinic.
Group II: HOP-STEP (Healthy Outcomes in Pregnancy with SLE Through Education of Providers) ProvidersExperimental Treatment1 Intervention
HOP-STEP providers will inquire and document their patients about contraceptive usage and pregnancy interest, then provide personalized guidance on family planning.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Routine Care
2008
Completed Phase 4
~2210
Find a Location
Who is running the clinical trial?
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)NIH
485 Previous Clinical Trials
1,086,879 Total Patients Enrolled
2 Trials studying Lupus
270 Patients Enrolled for Lupus
University of ChicagoOTHER
1,004 Previous Clinical Trials
819,757 Total Patients Enrolled
National Institutes of Health (NIH)NIH
2,705 Previous Clinical Trials
7,507,201 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:Research Study Groups:
This trial has the following groups:- Group 1: Routine Care Providers
- Group 2: HOP-STEP (Healthy Outcomes in Pregnancy with SLE Through Education of Providers) Providers
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.
Are there any opportunities to enroll in this research endeavor?
"In accordance with the clinicaltrials.gov information, this medical experiment is not currently seeking patients. It was originally posted on May 1st 2023 and last updated April 17th 2023. While this trial isn't open to recruitment at present, there are still 190 other studies actively recruiting participants right now."
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