Clinical trial NCT04616612: Medication Adherence Given Individual SystemCHANGE(TM) in Advancing Nephropathy (MAGICIAN) Pilot Study
Official title: Medication Adherence Given Individual SystemCHANGE(TM) in Advancing Nephropathy (MAGICIAN) Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Kidney Disease(CKD)
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
First posted: 2020-11-05
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two-group, randomized, controlled trial
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of Daily Doses of Medication Taken as Prescribed (Medication Adherence)
timeFrame: 8 Weeks
measure: Percentage of Daily Doses of Medication Taken as Prescribed (Medication Adherence)
timeFrame: 12 Weeks
Secondary outcomes:
measure: Number of Participants Qualitatively Analyzed From the Investigator-designed 10-item Acceptability Questionnaire Which Assesses Nurse-intervention Interaction and Mobile Technology Acceptability.
timeFrame: 12 weeks
measure: Outcome Expectancy Questionnaire
timeFrame: 8 Weeks
measure: Outcome Expectancy Questionnaire
timeFrame: 12 Weeks
measure: Credibility Questionnaire
timeFrame: 8 weeks
measure: Credibility Questionnaire
timeFrame: 12 Weeks
measure: Personal Systems Thinking
timeFrame: 8 Weeks
measure: Personal Systems Thinking
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University School of Nursing
state: Indiana
Study officials:
affiliation: Indiana University School of Medicine
name: Rebecca J. Ellis, PhD
role: PRINCIPAL_INVESTIGATOR
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