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Behavioral Intervention
Patient Education Program for Chronic Kidney Disease (MAGICIAN Trial)
N/A
Waitlist Available
Led By Rebecca J. Ellis, PhD
Research Sponsored by Indiana University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Self-reported ability to open a pill cap
Able to self-administer RAAS inhibiting medications
Must not have
Kidney and kidney-pancreas transplant recipients will be excluded
Participants with kidney failure defined by GFR <15 mL/min/1.73
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights
No Placebo-Only Group
Summary
This trial compares a new patient education system against a control group in kidney disease patients taking medications to regulate blood pressure.
Who is the study for?
This trial is for adults over 18 with chronic kidney disease who are prescribed RAAS inhibiting medication but have a less than perfect track record of taking it. They must be able to manage their own medications, speak English, and not suffer from severe cognitive impairments or life-shortening conditions like metastatic cancer.
What is being tested?
The MAGICIAN study compares two methods: SystemCHANGE™, which aims to improve patients' habits and routines around taking their medication, versus standard patient education (attention control). Participants will be randomly assigned to one of these groups.
What are the potential side effects?
Since the interventions involve behavioral strategies rather than drugs, traditional side effects aren't expected. However, participants may experience stress or frustration if they struggle with changing habits or adhering to the program's requirements.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can open a pill cap by myself.
Select...
I can take my RAAS inhibitor medication by myself.
Select...
I am older than 18 years.
Select...
I am taking medication daily to manage my blood pressure or heart condition.
Select...
My kidney function is reduced but not at its worst stage.
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I do not have any other life-shortening conditions.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have not had a kidney or kidney-pancreas transplant.
Select...
My kidney function is very low.
Select...
I am not on dialysis nor planning to start it soon.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in Personal Systems Behavior
Percentage of daily doses of medication taken as prescribed (Medication Adherence)
Secondary study objectives
Outcome Expectancy and Credibility
The investigator-designed 10-item Acceptability Questionnaire assesses nurse-intervention interaction and mobility technology acceptability.
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: SystemCHANGE (TM)Experimental Treatment1 Intervention
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.
Group II: Attention ControlActive Control1 Intervention
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
First Studied
Drug Approval Stage
How many patients have taken this drug
SystemCHANGE (TM)
2021
N/A
~150
Find a Location
Who is running the clinical trial?
Indiana UniversityLead Sponsor
1,034 Previous Clinical Trials
1,118,797 Total Patients Enrolled
National Institute of Nursing Research (NINR)NIH
600 Previous Clinical Trials
10,377,862 Total Patients Enrolled
Rebecca J. Ellis, PhDPrincipal InvestigatorIndiana University School of Medicine
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