← Back to Search

SystemCHANGE for Kidney Disease (MAGIC Trial)

Phase 3
Waitlist Available
Research Sponsored by Cynthia Russell
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
Awards & highlights

MAGIC Trial Summary

With kidney transplant (KT) recipients as our exemplar population, our goal is to develop and test interventions that increase medication adherence (MA) in chronically ill adults. Among adult KT recipients, non-adherence to immunosuppressive medications (MNA) is the leading predictor of poor outcomes, including rejection, kidney loss, and death. An alarming one-third of KT patients experience MNA even though the problem is preventable. Adherence intervention studies have proven marginally effective for those with acute and chronic illnesses and ineffective for adult KT recipients. Using a randomized controlled trial design with an attention-control group, this R01 will test an innovative 6-month SystemCHANGE intervention to enhance immunosuppressive MA in adult non-adherent KT recipients. This intervention shows great promise for increasing MA with a large effect size of 1.4 in our pilot study. Grounded in the socio-ecological model, SystemCHANGE seeks to systematically improve MA behaviors by identifying and shaping routines, involving supportive others in routines, and using medication taking feedback through small patient-lead experiments to change and maintain behavior. The Medication Event Monitoring System cap, which contains microelectronics that record the date and time of the cap removal, will be used to measure MA. Persistence of the MA behavior change will be examined by evaluating the difference in MA between the two groups during the 6-month maintenance phase. Mediators and moderators of MA will be examined. Health outcomes will be compared and a cost-effectiveness analysis will be conducted.

MAGIC Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Medication Adherence Change from 6 Months to 12 Months
Medication Adherence Change from Baseline to 12 Months
Medication Adherence Change from Baseline to 6 Months
Secondary outcome measures
Acute rejection
BUN
Chronic rejection
+5 more

MAGIC Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: SystemCHANGEExperimental Treatment1 Intervention
SystemCHANGE supports patient-designed, interventionist-guided, small experiments to: 1) assess individual systems (including important others who shape medication taking) and the system's impact on medication taking and propose individual system solutions to improve MA, 2) implement the proposed individual systems' solutions to improve MA, 3) track MA data, and 4) evaluate MA data.
Group II: Patient-education attention-controlActive Control1 Intervention
The 6-month Patient education attention-control (AC) intervention includes 6 transplant educational materials, covering healthy post-transplant behavior, developed by the International Transplant Nurses Society. The RA calls Pps at 1, 2, 3, 4, 5 and 6 months to review the brochure information and answer any questions about it.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
SystemCHANGE
2017
N/A
~850

Find a Location

Who is running the clinical trial?

University of TennesseeOTHER
189 Previous Clinical Trials
141,945 Total Patients Enrolled
University of Missouri-ColumbiaOTHER
362 Previous Clinical Trials
628,030 Total Patients Enrolled
Cynthia RussellLead Sponsor

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~8 spots leftby Apr 2025