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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04616612
Acronym
MAGICIAN
Enrollment
150
Registered
2020-11-05
Start date
2021-12-15
Completion date
2024-02-06
Last updated
2025-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Kidney Disease(CKD)

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.

Interventions

BEHAVIORALSystemCHANGE (TM)

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.

OTHERAttention Control

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.

Sponsors

National Institute of Nursing Research (NINR)
CollaboratorNIH
Indiana University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Caregiver)

Intervention model description

Two-group, randomized, controlled trial

Eligibility

Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Percentage of Daily Doses of Medication Taken as Prescribed (Medication Adherence)8 WeeksMonitored by electronic MEMS caps (AARDEX Group, Belgium) which record the date and time the cap is removed as a proxy for medication being taken.

Secondary

MeasureTime frameDescription
Number of Participants Qualitatively Analyzed From the Investigator-designed 10-item Acceptability Questionnaire Which Assesses Nurse-intervention Interaction and Mobile Technology Acceptability.12 weeksResponse options ranging from 5 (strongly agree) to 1 (strongly disagree). There is no total score. Depending on question strongly agree or strongly disagree may be related to better acceptability of the intervention. Answers on this survey guided development of individual interview questions to be qualitatively evaluated. The items on the Acceptability Scale, for example, had response options ranging from 5 (strongly agree) to 1 (strongly disagree). If a person indicated strong agreement with the item Getting messages on the mobile phone helps support my health behaviors, we would develop interview questions to read You indicated on your survey that getting messages on your phone supported your health behaviors. Tell me what behaviors the messages supported? Give me an example one of these behaviors.
Outcome Expectancy Questionnaire8 WeeksThis questionnaire measures the affective or emotional aspect of the client's expectations regarding improvement. It asks how much the client expects to improve as a result of the intervention. This is related to the client's emotional responses and affective processes, capturing their hopeful anticipation or optimism about the intervention outcomes. Higher scores indicate greater belief that the program will be beneficial. For outcome expectancy, the three questions will indicate how much they 1) think and 2) feel the program will help improve medication-taking using a 0 to 10 scale where 0 is no change and 10 is complete improvement, and how much they 3) feel it will reduce missing or taking medications late using 0 (the intervention won't help to reduce missed doses) to 10 (I won't miss any doses). Responses to the three questions are standardized and summed to create a total subscale score (range 0-30).
Credibility Questionnaire8 weeksThis questionnaire measures the logical and cognitive evaluation of the treatment. It assesses how credible or believable the treatment seems to the client. Questions on this scale typically ask about the perceived scientific legitimacy, logic, and reliability of the treatment. It taps into the client's rational thought processes and their cognitive appraisal of the treatment's potential effectiveness. Scores on the 3 questions indicate belief the program is credible. For treatment credibility items, participants indicate how 1) logical the program is and 2) how successfully they think it will help prevent missing or taking medications late, and 3) confidence recommending it to a friend all on a 0 to 10 scale and where 0 not logical, not credible, and participant is not confident in recommending to a friend to 10 logical, credible, and would recommend to a friend. Responses are standardized and summed to create a total subscale score on the three questions for a range of 0-30.
Personal Systems Thinking8 Weeks20-item Systems Thinking Scale (adapted for patients) was totaled from a 5-point scale (Never, Seldom, Some of the time, Often, Most of the time). Range 20 (personal motivation) -100 (system level thinking). This survey assesses participants view of behavior from a personal (motivation) level to a system (environmental) level. This scale evaluates intervention to improve systems thinking away from a personal motivational thinking. The total score was calculated to evaluate how thinking changed from baseline to 8 weeks and 12 weeks between the groups. Dolansky, M. A., et. al (2020).

Countries

United States

Participant flow

Pre-assignment details

Excluded (n = 128) * High Adherence (n=53) * Lost to follow up (n=41) * Change in medication (n=9) * Withdrew Consent (n=6) * Hospitalization (n=4) * Death (n=0) * Other (n=15) * Cap not received (n=7) * Too busy (n=2) * Caregiver (n=2) * Refused to participate in next phase (n=1) * Did not meet inclusion criteria (n=1) * Utilizing Pill Packs (n=1) * Cap sent back early without communication (n=1)

Participants by arm

ArmCount
SystemCHANGE (TM)
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. SystemCHANGE (TM): 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.
10
Attention Control
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. Attention Control: 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.
12
Total22

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyLost to Follow-up63

Baseline characteristics

CharacteristicSystemCHANGE (TM)TotalAttention Control
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
6 Participants9 Participants3 Participants
Age, Categorical
Between 18 and 65 years
4 Participants13 Participants9 Participants
Age, Continuous69.5 years
STANDARD_DEVIATION 9.1
64.0 years
STANDARD_DEVIATION 9.59
59.4 years
STANDARD_DEVIATION 7.56
CKD etiology
Diabetes
0 Participants4 Participants4 Participants
CKD etiology
Focal segmental glomerulosclerosis (FSGS)
0 Participants1 Participants1 Participants
CKD etiology
Hypertension
3 Participants4 Participants1 Participants
CKD etiology
Not documented
7 Participants12 Participants5 Participants
CKD etiology
Sickle Cell
0 Participants1 Participants1 Participants
CKD Stage
Stage 1
0 Participants0 Participants0 Participants
CKD Stage
Stage 2
0 Participants2 Participants2 Participants
CKD Stage
Stage 3a
4 Participants11 Participants7 Participants
CKD Stage
Stage 3b
3 Participants5 Participants2 Participants
CKD Stage
Stage 4
3 Participants4 Participants1 Participants
Co-morbidities
Diabetes
8 Participants17 Participants9 Participants
Co-morbidities
Hypertension
10 Participants21 Participants11 Participants
Education
College Graduate or Higher
5 Participants5 Participants0 Participants
Education
High school graduate
1 Participants4 Participants3 Participants
Education
Less than high school
1 Participants1 Participants0 Participants
Education
Some college
3 Participants10 Participants7 Participants
Education
Some high school
0 Participants2 Participants2 Participants
Employment Status
Disabled
2 Participants6 Participants4 Participants
Employment Status
Employed Full Time
1 Participants5 Participants4 Participants
Employment Status
Employed Part Time
0 Participants1 Participants1 Participants
Employment Status
Retired
7 Participants10 Participants3 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants2 Participants2 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
9 Participants19 Participants10 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
1 Participants1 Participants0 Participants
Income
$25,000 to $50,000/ yr
0 Participants3 Participants3 Participants
Income
Less than $25,000/yr
5 Participants9 Participants4 Participants
Income
Over $50,000/yr
4 Participants8 Participants4 Participants
Income
Refuse to Answer
1 Participants2 Participants1 Participants
Insurance Coverage
Don't Know
1 Participants1 Participants0 Participants
Insurance Coverage
Medicaid
3 Participants9 Participants6 Participants
Insurance Coverage
Medicare
5 Participants9 Participants4 Participants
Insurance Coverage
Medicare plus a supplementary policy
2 Participants2 Participants0 Participants
Insurance Coverage
Military/ VA
0 Participants0 Participants0 Participants
Insurance Coverage
Other
1 Participants3 Participants2 Participants
Insurance Coverage
Private Health Insurance
1 Participants6 Participants5 Participants
Insurance Coverage
Refuse to Answer
0 Participants0 Participants0 Participants
Marital Status
Divorced
2 Participants7 Participants5 Participants
Marital Status
Married
2 Participants4 Participants2 Participants
Marital Status
Never Married
3 Participants7 Participants4 Participants
Marital Status
Widowed
3 Participants4 Participants1 Participants
Number of Prescribed Daily Medications8.8 Number of Prescribed Medications9.7 Number of Prescribed Medications10.4 Number of Prescribed Medications
Over the counter medication2.5 Number of OTC Medications2 Number of OTC Medications1.5 Number of OTC Medications
Perceived Health Status
Excellent
1 Participants1 Participants0 Participants
Perceived Health Status
Good/Fair
7 Participants16 Participants9 Participants
Perceived Health Status
Poor
1 Participants2 Participants1 Participants
Perceived Health Status
Very Good
1 Participants3 Participants2 Participants
Perceived Health Status
Very Poor
0 Participants0 Participants0 Participants
Pill Box Usage
No
5 Participants13 Participants8 Participants
Pill Box Usage
Yes
5 Participants9 Participants4 Participants
Pre-Trial Medication Adherence (8 Weeks-Screening)83 Percentage
STANDARD_DEVIATION 9
72 Percentage
STANDARD_DEVIATION 17
65 Percentage
STANDARD_DEVIATION 18
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
6 Participants15 Participants9 Participants
Race (NIH/OMB)
More than one race
0 Participants1 Participants1 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
4 Participants6 Participants2 Participants
Region of Enrollment
United States
10 participants22 participants12 participants
Sex: Female, Male
Female
5 Participants7 Participants2 Participants
Sex: Female, Male
Male
5 Participants15 Participants10 Participants
Systems Thinking Scale66 units on a scale
STANDARD_DEVIATION 17.06
70.16 units on a scale
STANDARD_DEVIATION 16.11
70.92 units on a scale
STANDARD_DEVIATION 17.52

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 100 / 12
other
Total, other adverse events
0 / 100 / 12
serious
Total, serious adverse events
0 / 100 / 12

Outcome results

Primary

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.

Time frame: 12 Weeks

ArmMeasureValue (MEAN)Dispersion
SystemCHANGE (TM)Percentage of Daily Doses of Medication Taken as Prescribed (Medication Adherence)91 percentage of Daily dosesStandard Deviation 9
Attention ControlPercentage of Daily Doses of Medication Taken as Prescribed (Medication Adherence)59 percentage of Daily dosesStandard Deviation 26
p-value: 0.04ANCOVA
Primary

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.

Time frame: 8 Weeks

ArmMeasureValue (MEAN)Dispersion
SystemCHANGE (TM)Percentage of Daily Doses of Medication Taken as Prescribed (Medication Adherence)98 percentage of Daily dosesStandard Deviation 2
Attention ControlPercentage of Daily Doses of Medication Taken as Prescribed (Medication Adherence)74 percentage of Daily dosesStandard Deviation 17
p-value: 0.04Mixed Models Analysis
Secondary

Credibility Questionnaire

This questionnaire measures the logical and cognitive evaluation of the treatment. It assesses how credible or believable the treatment seems to the client. Questions on this scale typically ask about the perceived scientific legitimacy, logic, and reliability of the treatment. It taps into the client's rational thought processes and their cognitive appraisal of the treatment's potential effectiveness. Scores on the 3 questions indicate belief the program is credible. For treatment credibility items, participants indicate how 1) logical the program is and 2) how successfully they think it will help prevent missing or taking medications late, and 3) confidence recommending it to a friend all on a 0 to 10 scale and where 0 not logical, not credible, and participant is not confident in recommending to a friend to 10 logical, credible, and would recommend to a friend. Responses are standardized and summed to create a total subscale score on the three questions for a range of 0-30.

Time frame: 8 weeks

ArmMeasureValue (MEAN)Dispersion
SystemCHANGE (TM)Credibility Questionnaire28.67 score on a scaleStandard Deviation 1.37
Attention ControlCredibility Questionnaire25.56 score on a scaleStandard Deviation 3.5
p-value: 0.66Mixed Models Analysis
Secondary

Credibility Questionnaire

This questionnaire measures the logical and cognitive evaluation of the treatment. It assesses how credible or believable the treatment seems to the client. Questions on this scale typically ask about the perceived scientific legitimacy, logic, and reliability of the treatment. It taps into the client's rational thought processes and their cognitive appraisal of the treatment's potential effectiveness. Scores on the 3 questions indicate belief the program is credible. For treatment credibility items, participants indicate how 1) logical the program is and 2) how successfully they think it will help prevent missing or taking medications late, and 3) confidence recommending it to a friend all on a 0 to 10 scale and where 0 not logical, not credible, and participant is not confident in recommending to a friend to 10 logical, credible, and would recommend to a friend. Responses are standardized and summed to create a total subscale score on the three questions for a range of 0-30.

Time frame: 12 Weeks

ArmMeasureValue (MEAN)Dispersion
SystemCHANGE (TM)Credibility Questionnaire26.67 score on a scaleStandard Deviation 4.37
Attention ControlCredibility Questionnaire25.89 score on a scaleStandard Deviation 4.86
p-value: 0.66Mixed Models Analysis
Secondary

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

Response options ranging from 5 (strongly agree) to 1 (strongly disagree). There is no total score. Depending on question strongly agree or strongly disagree may be related to better acceptability of the intervention. Answers on this survey guided development of individual interview questions to be qualitatively evaluated. The items on the Acceptability Scale, for example, had response options ranging from 5 (strongly agree) to 1 (strongly disagree). If a person indicated strong agreement with the item Getting messages on the mobile phone helps support my health behaviors, we would develop interview questions to read You indicated on your survey that getting messages on your phone supported your health behaviors. Tell me what behaviors the messages supported? Give me an example one of these behaviors.

Time frame: 12 weeks

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
SystemCHANGE (TM)Number of Participants Qualitatively Analyzed From the Investigator-designed 10-item Acceptability Questionnaire Which Assesses Nurse-intervention Interaction and Mobile Technology Acceptability.6 Participants
Attention ControlNumber of Participants Qualitatively Analyzed From the Investigator-designed 10-item Acceptability Questionnaire Which Assesses Nurse-intervention Interaction and Mobile Technology Acceptability.8 Participants
Secondary

Outcome Expectancy Questionnaire

This questionnaire measures the affective or emotional aspect of the client's expectations regarding improvement. It asks how much the client expects to improve as a result of the intervention. This is related to the client's emotional responses and affective processes, capturing their hopeful anticipation or optimism about the intervention outcomes. Higher scores indicate greater belief that the program will be beneficial. For outcome expectancy, the three questions will indicate how much they 1) think and 2) feel the program will help improve medication-taking using a 0 to 10 scale where 0 is no change and 10 is complete improvement, and how much they 3) feel it will reduce missing or taking medications late using 0 (the intervention won't help to reduce missed doses) to 10 (I won't miss any doses). Responses to the three questions are standardized and summed to create a total subscale score (range 0-30).

Time frame: 12 Weeks

ArmMeasureValue (MEAN)Dispersion
SystemCHANGE (TM)Outcome Expectancy Questionnaire26.83 score on a scaleStandard Deviation 3.13
Attention ControlOutcome Expectancy Questionnaire24.57 score on a scaleStandard Deviation 7.04
p-value: 0.11Mixed Models Analysis
Secondary

Outcome Expectancy Questionnaire

This questionnaire measures the affective or emotional aspect of the client's expectations regarding improvement. It asks how much the client expects to improve as a result of the intervention. This is related to the client's emotional responses and affective processes, capturing their hopeful anticipation or optimism about the intervention outcomes. Higher scores indicate greater belief that the program will be beneficial. For outcome expectancy, the three questions will indicate how much they 1) think and 2) feel the program will help improve medication-taking using a 0 to 10 scale where 0 is no change and 10 is complete improvement, and how much they 3) feel it will reduce missing or taking medications late using 0 (the intervention won't help to reduce missed doses) to 10 (I won't miss any doses). Responses to the three questions are standardized and summed to create a total subscale score (range 0-30).

Time frame: 8 Weeks

ArmMeasureValue (MEAN)Dispersion
SystemCHANGE (TM)Outcome Expectancy Questionnaire29 score on a scaleStandard Deviation 1.3
Attention ControlOutcome Expectancy Questionnaire23.7 score on a scaleStandard Deviation 5.6
p-value: 0.11Mixed Models Analysis
Secondary

Personal Systems Thinking

20-item Systems Thinking Scale (adapted for patients) was totaled from a 5-point scale (Never, Seldom, Some of the time, Often, Most of the time). Range 20 (personal motivation) -100 (system level thinking). This survey assesses participants view of behavior from a personal (motivation) level to a system (environmental) level. This scale evaluates intervention to improve systems thinking away from a personal motivational thinking. The total score was calculated to evaluate how thinking changed from baseline to 8 weeks and 12 weeks between the groups. Dolansky, M. A., et. al (2020).

Time frame: 8 Weeks

ArmMeasureValue (MEAN)Dispersion
SystemCHANGE (TM)Personal Systems Thinking68.5 score on a scaleStandard Deviation 15.06
Attention ControlPersonal Systems Thinking69.5 score on a scaleStandard Deviation 18.51
p-value: 0.84Mixed Models Analysis
Secondary

Personal Systems Thinking

20-item Systems Thinking Scale (adapted for patients) was totaled from a 5-point scale (Never, Seldom, Some of the time, Often, Most of the time). Range 20 (personal motivation) -100 (system level thinking). This survey assesses participants view of behavior from a personal (motivation) level to a system (environmental) level. This scale evaluates intervention to improve systems thinking away from a personal motivational thinking. The total score was calculated to evaluate how thinking changed from baseline to 8 weeks and 12 weeks between the groups. Dolansky, M. A., et. al (2020).

Time frame: 12 weeks

ArmMeasureValue (MEAN)Dispersion
SystemCHANGE (TM)Personal Systems Thinking64.11 score on a scaleStandard Deviation 13.27
Attention ControlPersonal Systems Thinking76.17 score on a scaleStandard Deviation 15.68
p-value: 0.84Mixed Models Analysis

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026