Medication Adherence Given Individual SystemCHANGE(TM) in Advancing Nephropathy (MAGICIAN) Pilot Study
Completed · Not applicable
Conditions studied: Chronic Kidney Disease(CKD)
In brief
The purpose of this 2-group, randomized, controlled trial is to evaluate the refined SystemCHANGE™ against attention control patient education in CKD patients taking RAAS medications.
Key facts
- Study ID
- NCT04616612
- Run by
- Indiana University
- People needed
- 150
- Starts
- 2021-12-15
- Expected to finish
- 2024-02-06
- Last updated by the study team
- 2025-04-23
Who can join
Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- age > 18 years
- prescribed at least 1 daily RAAS inhibiting medication
- CKD diagnosis estimated glomerular filtration rate (eGFR) category G1 to G4
- RAAS inhibiting medication adherence of <.85 documented during the screening phase
- proteinuria defined as a urine Protein-to-Creatinine ratio > 150 mg/g or urine Albumin-to-Creatinine ratio >30mg/g
- able to speak, hear, and understand English determined by the ability to participate and comprehend conversation about potential inclusion in the study
- self-reported ability to open a pill cap
- able to self-administer RAAS inhibiting medications
- willing to use a study phone
- has no cognitive impairment as determined by a score of 4 or greater on the 6-item Telephone Mental Status Screen Derived from the Mini-Mental Status Exam (cognitive screener)
- has no other diagnoses that may shorten life span, such as metastatic cancer
- is not currently hospitalized
- receives care through two approved health care systems
You may not qualify if…
- Participants with kidney failure defined by GFR <15 mL/min/1.73
- Participants will be excluded if they are receiving dialysis or have dialysis access placed (e.g. graft or arteriovenous fistula) in anticipation of starting dialysis.
- Kidney and kidney-pancreas transplant recipients will be excluded.
Where it is running
- Indiana University School of Nursing — Indianapolis, Indiana, United States
Full record on ClinicalTrials.gov
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