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

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? efficacy to improve medication adherence in this population, with broad translational impact to other populations prescribed daily medication regimens.