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

> **NIH NIH R21** · INDIANA UNIVERSITY INDIANAPOLIS · 2021 · $198,125

## Abstract

ABSTRACT
Medication nonadherence prevents people with CKD from achieving the full benefits from medications that
inhibit the renin-angiotensin-aldosterone system (RAAS) and improve patient outcomes. Although medication
nonadherence is avoidable, more than 50% of people with CKD experience this problem and adherence
interventions are lacking for people with chronic illness such as those with CKD. This project will test an
innovative digital health SystemCHANGETM intervention (SystemCHANGE™-Digi) to improve medication
adherence to medications that interrupt the RAAS compared with an attention control of patient education
(Control-Digi) among people with CKD who have poor medication adherence. The purpose of this study is to
compare the acceptability of the SystemCHANGE™-Digi experimental intervention vs. attention control,
Control-Digi, to determine if both interventions are acceptable and credible, and to generate preliminary
efficacy on the outcome of medication adherence between the intervention and attention control groups in CKD
patients taking RAAS inhibiting medications recruited from two large health care systems. Following a 2-month
screening period, outcomes are assessed at baseline, 8 weeks, and 12 weeks. Specific aims are to: Aim 1.
Compare acceptability, outcome expectancy and credibility of the SystemCHANGE™-Digi versus Control-Digi
using qualitative and quantitative data. Aim 2. Estimate preliminary efficacy of SystemCHANGE™-Digi versus
Control-Digi on medication adherence (primary outcome) and personal systems behavior (mechanism of
action) at 8 and 12 weeks. A sample of 66 individuals with CKD and poor adherence to a RAAS inhibiting
medication will be assigned at random to: 1) SytemCHANGE™-Digi or a 2) attention control-Digi.
SystemCHANGETM harnesses reliable person-centered systems that people have already established – their
daily routines, the environment, and important others, and by using a continuous self-improvement process to
align medication-taking with existing reliable personal systems. SystemCHANGETM -Digi capitalizes on
telehealth and mobile technologies to deliver intervention content and process improvement feedback by
tablet. SystemCHANGE™-Digi is delivered in 7 nurse-interventionist guided telehealth sessions and weekly
feedback reports sent to participants’ tablets by multimedia messaging service (MMS) for 6 weeks. The
attention control (patient education) matches the time spent with a nurse-interventionist in SystemCHANGETM
intervention and delivery of the same number of MMS messages. Data collection will be completed at baseline,
8 weeks, and 12 weeks. For Aim 1, tabulated responses to acceptability, outcome expectancy and credibility
items will be combined with qualitative data using joint display tables. For Aim 2, effect sizes will be estimated
by fitting ANCOVA models with treatment group and outcomes of adherence and personal systems behavior.
This research will provide new knowledge about SystemCHANGE™ eff...

## Key facts

- **NIH application ID:** 10372503
- **Project number:** 1R21NR019348-01A1
- **Recipient organization:** INDIANA UNIVERSITY INDIANAPOLIS
- **Principal Investigator:** Rebecca Ellis
- **Activity code:** R21 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $198,125
- **Award type:** 1
- **Project period:** 2021-09-23 → 2023-07-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10372503

## Citation

> US National Institutes of Health, RePORTER application 10372503, Medication Adherence Given Individual systemCHANGE™ in Advancing Nephropathy (MAGICIAN) Pilot Study (1R21NR019348-01A1). Retrieved via AI Analytics 2026-05-27 from https://api.ai-analytics.org/grant/nih/10372503. Licensed CC0.

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