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

Indiana University

Status: Completed

Conditions: Chronic Kidney Disease(CKD)

Treatments: Other: Attention Control; Behavioral: SystemCHANGE (TM)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04616612

R21NR019348-02 (U.S. NIH Grant/Contract)

2001957718

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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150 participants in 2 patient groups

SystemCHANGE (TM)

Experimental group

Description:

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.

Treatment:

Behavioral: SystemCHANGE (TM)

Attention Control

Active Comparator group

Description:

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.

Treatment:

Other: Attention Control