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Completed

NCT Number: NCT04616612

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

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.

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Key information

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Indiana University School of Nursing

Indianapolis, Indiana, 46202, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Percentage of Daily Doses of Medication Taken as Prescribed (Medication Adherence)

    Time frame: 8 Weeks

    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.

  2. Percentage of Daily Doses of Medication Taken as Prescribed (Medication Adherence)

    Time frame: 12 Weeks

    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.

Secondary outcomes

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

    Time frame: 12 weeks

    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."

  2. Outcome Expectancy Questionnaire

    Time frame: 8 Weeks

    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).

  3. Outcome Expectancy Questionnaire

    Time frame: 12 Weeks

    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).

  4. Credibility Questionnaire

    Time frame: 8 weeks

    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.

  5. Credibility Questionnaire

    Time frame: 12 Weeks

    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.

  6. Personal Systems Thinking

    Time frame: 8 Weeks

    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).

  7. Personal Systems Thinking

    Time frame: 12 weeks

    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).

Sponsors and collaborators

Lead sponsor

Indiana University

Other

Collaborators

  • National Institute of Nursing Research (NINR)

Registry information

Acronym: MAGICIAN

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Nov 5, 2020
Registry last updated
Apr 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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