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Integrated Care Management for Lupus (Rheum-iCMP Trial)

N/A
Waitlist Available
Led By Candace H Feldman, MD, ScD
Research Sponsored by Brigham and Women's Hospital
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 12 months prior to intervention compared to the 12 months during the intervention, beginning at the start of the intervention
Awards & highlights
No Placebo-Only Group

Summary

This trialwill study lupus patients at BWH to identify those at high risk of adverse outcomes, and offer intensive care management to reduce avoidable ED visits, hospitalizations and improve high quality care.

Who is the study for?
This trial is for lupus patients at Brigham and Women's Hospital who've had a hospital visit or missed an appointment in the last 3 years, get their primary care there, and meet specific lupus diagnosis criteria. It's not open to those who don't speak English or Spanish.
What is being tested?
The study tests an intensive care management program (Rheum iCMP) involving a nurse manager for high-risk lupus patients. The goal is to see if it improves regular outpatient care and reduces unnecessary emergency visits and hospital stays.
What are the potential side effects?
Since this trial involves a care management program rather than medication, traditional side effects are not applicable. However, participants may experience changes in healthcare delivery that could affect their routine.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months prior to intervention compared to the 12 months during the intervention, beginning at the start of the intervention
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months prior to intervention compared to the 12 months during the intervention, beginning at the start of the 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
Composite measure of acute care utilization
Lupus-related appointment nonadherence
Quality of Lupus Care: SLE Quality Metric Scoring System for Adults
Secondary study objectives
Beliefs About Medications Survey
Everyday Discrimination Scale
Medication Adherence Self-Report Inventory (MASRI)
+4 more

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
Group I: Rheum iCMP Wave 2Experimental Treatment1 Intervention
20 patients enrolled in Rheum iCMP after 4 months; will receive monthly lupus educational materials mailed to their home during the first 4 months
Group II: Rheum iCMP Wave 1Experimental Treatment1 Intervention
20 patients enrolled immediately in Rheum iCMP

Find a Location

Who is running the clinical trial?

Brigham and Women's HospitalLead Sponsor
1,670 Previous Clinical Trials
11,878,126 Total Patients Enrolled
2 Trials studying Lupus
408 Patients Enrolled for Lupus
Partners HealthCareOTHER
14 Previous Clinical Trials
54,999 Total Patients Enrolled
Candace H Feldman, MD, ScDPrincipal InvestigatorBrigham and Women's Hospital
2 Previous Clinical Trials
263 Total Patients Enrolled

Media Library

Rheum iCMP Clinical Trial Eligibility Overview. Trial Name: NCT03915652 — N/A
Lupus Research Study Groups: Rheum iCMP Wave 1, Rheum iCMP Wave 2
Lupus Clinical Trial 2023: Rheum iCMP Highlights & Side Effects. Trial Name: NCT03915652 — N/A
Rheum iCMP 2023 Treatment Timeline for Medical Study. Trial Name: NCT03915652 — N/A
~22 spots leftby Dec 2025
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