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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Chronic Kidney Disease(CKD)

Intervention / Treatment
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* Behavioral: SystemCHANGE (TM)
* Other: Attention Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Two-group, randomized, controlled trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SystemCHANGE (TM)<br>SystemCHANGE™ focuses on using patients' already established and reliable systems to support medication-taking, rather than focusing on personal effort and remembering.When applied to medication adherence, the goal is to reduce medication-taking variability and move towards consistently taking medication with a 6-hour window of time (for daily medications like RAAS) and avoid missing medications. SystemCHANGE™ improvement cycles rely on efficient use of performance feedback in order to make decisions about whether system solutions work or if there is a need to select other solutions. | Behavioral: SystemCHANGE (TM)<br>* 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.<br>|
| Active Comparator: Attention Control<br>Participants in the attention control will receive educational materials about chronic kidney disease (CKD). The content will be focused on diet, exercise, and living with CKD. | Other: Attention Control<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of daily doses of medication taken as prescribed (Medication Adherence) | Monitored by electronic MEMS caps (AARDEX Group, Belgium) which record the date and time the cap is removed as a proxy for medication being taken. | Up to 8 Weeks | 
| Percentage of daily doses of medication taken as prescribed (Medication Adherence) | Monitored by electronic MEMS caps (AARDEX Group, Belgium) which record the date and time the cap is removed as a proxy for medication being taken. | Up to 12 Weeks | 
| Change in Personal Systems Behavior | 20-item Systems Thinking Survey (adapted for patients) on a 5-point Likert scale. This survey assesses if the participants view on behavior at a personal (motivation) or system level. | Change from Baseline to 12 weeks | 
| Percentage of daily doses of medication taken as prescribed (Medication Adherence) | Monitored by electronic MEMS caps (AARDEX Group, Belgium) which record the date and time the cap is removed as a proxy for medication being taken. | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The investigator-designed 10-item Acceptability Questionnaire assesses nurse-intervention interaction and mobility technology acceptability. | Response options ranging from 5 (strongly agree) to 1 (strongly disagree). Because this is an investigator designed assessment, will use individual item scores for analysis. | 12 weeks | 
| Outcome Expectancy and Credibility | Scores indicate greater belief that the program will be beneficial (outcome expectancy) or greater belief the program is credible (credibility). For outcome expectancy, participants will indicate how much they a) think and b) feel the program will help improve medication-taking using a 0% to 100% scale, and how much they c) feel it will reduce missing or taking medications late using response options from 1 (not at all) to 9 (very much). For treatment credibility items, participants indicate how a) logical the program is and b) how successfully they think it will help prevent missing or taking medications late, and c) confidence recommending it to a friend on a 1 to 9 scale and responses are standardized and summed to create a total subscale score. | Change from Baseline to 8 Weeks | 
| Outcome Expectancy and Credibility | Scores indicate greater belief that the program will be beneficial (outcome expectancy) or greater belief the program is credible (credibility). For outcome expectancy, participants will indicate how much they a) think and b) feel the program will help improve medication-taking using a 0% to 100% scale, and how much they c) feel it will reduce missing or taking medications late using response options from 1 (not at all) to 9 (very much). For treatment credibility items, participants indicate how a) logical the program is and b) how successfully they think it will help prevent missing or taking medications late, and c) confidence recommending it to a friend on a 1 to 9 scale and responses are standardized and summed to create a total subscale score. | Change from Baseline to 12 Weeks |