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

NCT04616612 | Completed Results DMC

• 2 other identifiers: 2001957718R21NR019348-02
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Kidney Disease(CKD)

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  12 Weeks

Secondary Outcomes (7)

• Number of Participants Qualitatively Analyzed From the Investigator-designed 10-item Acceptability Questionnaire Which Assesses Nurse-intervention Interaction and Mobile Technology Acceptability.

  12 weeks

• Outcome Expectancy Questionnaire

  8 Weeks

• Outcome Expectancy Questionnaire

  12 Weeks

• Credibility Questionnaire

  8 weeks

• Credibility Questionnaire

  12 Weeks

Study Arms (2)

SystemCHANGE (TM)

EXPERIMENTAL

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)

Attention Control

ACTIVE COMPARATOR

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

Interventions

SystemCHANGE (TM) BEHAVIORAL

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.

SystemCHANGE (TM)

Attention Control OTHER

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.

Attention Control

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Indiana University: lead
• National Institute of Nursing Research (NINR): collaborator

Study Sites (1)

Indiana University School of Nursing

Indianapolis, Indiana, 46202, United States

Location

Related Publications (50)

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  RESULT

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Rebecca Bartlett Ellis
• Organization: Indiana University

rjbartle@iu.edu

3172740047

Study Officials

• Rebecca J. Ellis, PhD

  Indiana University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Two-group, randomized, controlled trial

Study Record Dates

• First Submitted: September 17, 2020
• First Posted: November 5, 2020
• Study Start: December 15, 2021
• Primary Completion: February 6, 2024
• Study Completion: February 6, 2024
• Last Updated: April 23, 2025
• Results First Posted: April 23, 2025

Record last verified: 2025-04

Locations

US (1)