NCT04616612

Medication Adherence Given Individual SystemCHANGE(TM) in Advancing Nephropathy (MAGICIAN) Pilot Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (actual)
• Sponsor: Indiana University · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

In this study, the investigators will test a refined SystemCHANGE™ in patients taking RAAS inhibiting medications. Participants will be recruited from two sources: 1) the largest and most comprehensive health care system in the state and 2) one of the largest essential health care systems in the country. Data are collected at baseline, 8 weeks (immediately post-intervention), and 12 weeks.

Conditions

• Chronic Kidney Disease(CKD)

Interventions

Type	Name	Description
BEHAVIORAL	SystemCHANGE (TM)	Participants randomized to the refined SystemCHANGE™ intervention will receive 7 personalized sessions with a nurse-interventionist (session 1 virtual face-to-face, sessions 2-7 via phone) and weekly feedback MMS message reports delivered to mobile phones.
OTHER	Attention Control	Participants randomized to attention control will receive nurse-led kidney disease self-care education based on materials developed by The National Institute of Diabetes and Digestive and Kidney Diseases and The National Kidney Foundation. Similar to the intervention, participants will receive one virtual visit from the nurse-interventionist and 6 phone calls (weeks 2, 3, 4, 5, 6 and 7) and weekly educational MMS messages delivered by mobile phone.

Timeline

• Start date: 2021-12-15
• Primary completion: 2024-02-06
• Completion: 2024-02-06
• First posted: 2020-11-05
• Last updated: 2025-04-23
• Results posted: 2025-04-23

Locations

1 site across 1 country: United States