Chronic Kidney Disease(CKD)MAGICIANNCT04616612
Medication Adherence Given Individual SystemCHANGE(TM) in Advancing Nephropathy (MAGICIAN) Pilot Study
A study testing SystemCHANGE (TM) in people with Chronic Kidney Disease(CKD), run by Indiana University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Chronic Kidney Disease(CKD)
- What is being tested?
- SystemCHANGE (TM)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Dec 2021to 6 Feb 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 13Show fewer
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Indiana University School of Nursing
Indianapolis, Indiana, 46202
About this 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.
Read the 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.
- Conditions
- Chronic Kidney Disease(CKD)
- Being tested
- SystemCHANGE (TM), Attention Control
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SystemCHANGE (TM)Behavioural
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 ControlOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Attention Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
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."
Measured: 12 weeks
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).
Measured: 8 Weeks
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).
Measured: 12 Weeks
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.
Measured: 8 weeks
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.
Measured: 12 Weeks
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).
Measured: 8 Weeks
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).
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2020
- Study start15 Dec 2021
- Primary completion6 Feb 2024
- Study completion6 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (50)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney Disease(CKD)Studies of the same condition, open and under way.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two-group, randomized, controlled trial
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Responsible party
- Principal investigator, Rebecca Jane Ellis, Indiana University
- Investigators
- Rebecca J. Ellis, PhD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04616612
- Sponsor's protocol ID
- 2001957718
- Other IDs
- R21NR019348-02
- Acronym
- MAGICIAN
- Status last verified
- Apr 2025
- First submitted
- 17 Sep 2020
- Last updated
- 23 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Tangkiatkumjai M, Walker DM, Praditpornsilpa K, Boardman H. Association between medication adherence and clinical outcomes in patients with chronic kidney disease: a prospective cohort study. Clin Exp Nephrol. 2017 Jun;21(3):504-512. doi: 10.1007/s10157-016-1312-6. Epub 2016 Jul 20.
PubMed 27438073Muntner P, Judd SE, Krousel-Wood M, McClellan WM, Safford MM. Low medication adherence and hypertension control among adults with CKD: data from the REGARDS (Reasons for Geographic and Racial Differences in Stroke) Study. Am J Kidney Dis. 2010 Sep;56(3):447-57. doi: 10.1053/j.ajkd.2010.02.348. Epub 2010 May 14.
PubMed 20471734Cedillo-Couvert EA, Ricardo AC, Chen J, Cohan J, Fischer MJ, Krousel-Wood M, Kusek JW, Lederer S, Lustigova E, Ojo A, Porter AC, Sharp LK, Sondheimer J, Diamantidis C, Wang X, Roy J, Lash JP; CRIC Study Investigators. Self-reported Medication Adherence and CKD Progression. Kidney Int Rep. 2018 Feb 2;3(3):645-651. doi: 10.1016/j.ekir.2018.01.007. eCollection 2018 May.
PubMed 29854972Williams A, Manias E, Walker R, Gorelik A. A multifactorial intervention to improve blood pressure control in co-existing diabetes and kidney disease: a feasibility randomized controlled trial. J Adv Nurs. 2012 Nov;68(11):2515-25. doi: 10.1111/j.1365-2648.2012.05950.x. Epub 2012 Feb 15.
PubMed 22335395Ong SW, Jassal SV, Miller JA, Porter EC, Cafazzo JA, Seto E, Thorpe KE, Logan AG. Integrating a Smartphone-Based Self-Management System into Usual Care of Advanced CKD. Clin J Am Soc Nephrol. 2016 Jun 6;11(6):1054-1062. doi: 10.2215/CJN.10681015. Epub 2016 May 12.
PubMed 27173169Conn VS, Ruppar TM, Enriquez M, Cooper P. Medication adherence interventions that target subjects with adherence problems: Systematic review and meta-analysis. Res Social Adm Pharm. 2016 Mar-Apr;12(2):218-46. doi: 10.1016/j.sapharm.2015.06.001. Epub 2015 Jun 15.
PubMed 26164400Easthall C, Song F, Bhattacharya D. A meta-analysis of cognitive-based behaviour change techniques as interventions to improve medication adherence. BMJ Open. 2013 Aug 9;3(8):e002749. doi: 10.1136/bmjopen-2013-002749.
PubMed 23935093Haynes RB, Ackloo E, Sahota N, McDonald HP, Yao X. Interventions for enhancing medication adherence. Cochrane Database Syst Rev. 2008 Apr 16;(2):CD000011. doi: 10.1002/14651858.CD000011.pub3.
PubMed 18425859Ivers NM, Grimshaw JM, Jamtvedt G, Flottorp S, O'Brien MA, French SD, Young J, Odgaard-Jensen J. Growing literature, stagnant science? Systematic review, meta-regression and cumulative analysis of audit and feedback interventions in health care. J Gen Intern Med. 2014 Nov;29(11):1534-41. doi: 10.1007/s11606-014-2913-y.
PubMed 24965281Rambod M, Heine GH, Seiler S, Dominic EA, Rogacev KS, Dwivedi R, Ramezani A, Wing MR, Amdur RL, Fliser D, Raj DS. Association of vascular endothelial factors with cardiovascular outcome and mortality in chronic kidney disease patients: a 4-year cohort study. Atherosclerosis. 2014 Oct;236(2):360-5. doi: 10.1016/j.atherosclerosis.2014.07.026. Epub 2014 Aug 12.
PubMed 25128974Go AS, Chertow GM, Fan D, McCulloch CE, Hsu CY. Chronic kidney disease and the risks of death, cardiovascular events, and hospitalization. N Engl J Med. 2004 Sep 23;351(13):1296-305. doi: 10.1056/NEJMoa041031.
PubMed 15385656Debella YT, Giduma HD, Light RP, Agarwal R. Chronic kidney disease as a coronary disease equivalent--a comparison with diabetes over a decade. Clin J Am Soc Nephrol. 2011 Jun;6(6):1385-92. doi: 10.2215/CJN.10271110. Epub 2011 Mar 10.
PubMed 21393492Jafar TH, Stark PC, Schmid CH, Landa M, Maschio G, de Jong PE, de Zeeuw D, Shahinfar S, Toto R, Levey AS; AIPRD Study Group. Progression of chronic kidney disease: the role of blood pressure control, proteinuria, and angiotensin-converting enzyme inhibition: a patient-level meta-analysis. Ann Intern Med. 2003 Aug 19;139(4):244-52. doi: 10.7326/0003-4819-139-4-200308190-00006.
PubMed 12965979Evans M, Bain SC, Hogan S, Bilous RW; Collaborative Study Group participants. Irbesartan delays progression of nephropathy as measured by estimated glomerular filtration rate: post hoc analysis of the Irbesartan Diabetic Nephropathy Trial. Nephrol Dial Transplant. 2012 Jun;27(6):2255-63. doi: 10.1093/ndt/gfr696. Epub 2011 Dec 15.
PubMed 22172728Xie X, Atkins E, Lv J, Bennett A, Neal B, Ninomiya T, Woodward M, MacMahon S, Turnbull F, Hillis GS, Chalmers J, Mant J, Salam A, Rahimi K, Perkovic V, Rodgers A. Effects of intensive blood pressure lowering on cardiovascular and renal outcomes: updated systematic review and meta-analysis. Lancet. 2016 Jan 30;387(10017):435-43. doi: 10.1016/S0140-6736(15)00805-3. Epub 2015 Nov 7.
PubMed 26559744
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medication Adherence Given Individual SystemCHANGE(TM) in Advancing Nephropathy (MAGICIAN) Pilot Study
- ClinicalTrials.gov ID
- NCT04616612
- Acronym / sponsor ID
- MAGICIAN / 2001957718
- Conditions
- Chronic Kidney Disease(CKD)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Study start
- 15 Dec 2021 (actual)
- Primary completion
- 6 Feb 2024 (actual)
- Study completion
- 6 Feb 2024 (actual)
- First posted
- 5 Nov 2020 (actual)
- Results
- Posted 23 Apr 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
- Model description
- Two-group, randomized, controlled trial
| Arm | Type | Receives |
|---|---|---|
| SystemCHANGE (TM) | Experimental | Behavioral: 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. |
| Attention Control | Active comparator | Other: Attention ControlParticipants 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. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | SystemCHANGE (TM) |
| Attention ControlParticipants 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. | Other | Attention Control |
Primary outcome
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.
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.
7 secondary outcomes
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
Outcome Expectancy Questionnaire
Time frame: 8 Weeks
Outcome Expectancy Questionnaire
Time frame: 12 Weeks
Credibility Questionnaire
Time frame: 8 weeks
Credibility Questionnaire
Time frame: 12 Weeks
Personal Systems Thinking
Time frame: 8 Weeks
Personal Systems Thinking
Time frame: 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 27438073Tangkiatkumjai M, Walker DM, Praditpornsilpa K, Boardman H. Association between medication adherence and clinical outcomes in patients with chronic kidney disease: a prospective cohort study. Clin Exp Nephrol. 2017 Jun;21(3):504-512. doi: 10.1007/s10157-016-1312-6. Epub 2016 Jul 20.
- Background: PubMed 20471734Muntner P, Judd SE, Krousel-Wood M, McClellan WM, Safford MM. Low medication adherence and hypertension control among adults with CKD: data from the REGARDS (Reasons for Geographic and Racial Differences in Stroke) Study. Am J Kidney Dis. 2010 Sep;56(3):447-57. doi: 10.1053/j.ajkd.2010.02.348. Epub 2010 May 14.
- Background: PubMed 29854972Cedillo-Couvert EA, Ricardo AC, Chen J, Cohan J, Fischer MJ, Krousel-Wood M, Kusek JW, Lederer S, Lustigova E, Ojo A, Porter AC, Sharp LK, Sondheimer J, Diamantidis C, Wang X, Roy J, Lash JP; CRIC Study Investigators. Self-reported Medication Adherence and CKD Progression. Kidney Int Rep. 2018 Feb 2;3(3):645-651. doi: 10.1016/j.ekir.2018.01.007. eCollection 2018 May.
- Background: PubMed 22335395Williams A, Manias E, Walker R, Gorelik A. A multifactorial intervention to improve blood pressure control in co-existing diabetes and kidney disease: a feasibility randomized controlled trial. J Adv Nurs. 2012 Nov;68(11):2515-25. doi: 10.1111/j.1365-2648.2012.05950.x. Epub 2012 Feb 15.
- Background: PubMed 27173169Ong SW, Jassal SV, Miller JA, Porter EC, Cafazzo JA, Seto E, Thorpe KE, Logan AG. Integrating a Smartphone-Based Self-Management System into Usual Care of Advanced CKD. Clin J Am Soc Nephrol. 2016 Jun 6;11(6):1054-1062. doi: 10.2215/CJN.10681015. Epub 2016 May 12.
- Background: PubMed 26164400Conn VS, Ruppar TM, Enriquez M, Cooper P. Medication adherence interventions that target subjects with adherence problems: Systematic review and meta-analysis. Res Social Adm Pharm. 2016 Mar-Apr;12(2):218-46. doi: 10.1016/j.sapharm.2015.06.001. Epub 2015 Jun 15.
- Background: PubMed 23935093Easthall C, Song F, Bhattacharya D. A meta-analysis of cognitive-based behaviour change techniques as interventions to improve medication adherence. BMJ Open. 2013 Aug 9;3(8):e002749. doi: 10.1136/bmjopen-2013-002749.
- Background: PubMed 18425859Haynes RB, Ackloo E, Sahota N, McDonald HP, Yao X. Interventions for enhancing medication adherence. Cochrane Database Syst Rev. 2008 Apr 16;(2):CD000011. doi: 10.1002/14651858.CD000011.pub3.
- Background: PubMed 24965281Ivers NM, Grimshaw JM, Jamtvedt G, Flottorp S, O'Brien MA, French SD, Young J, Odgaard-Jensen J. Growing literature, stagnant science? Systematic review, meta-regression and cumulative analysis of audit and feedback interventions in health care. J Gen Intern Med. 2014 Nov;29(11):1534-41. doi: 10.1007/s11606-014-2913-y.
- Background: PubMed 25128974Rambod M, Heine GH, Seiler S, Dominic EA, Rogacev KS, Dwivedi R, Ramezani A, Wing MR, Amdur RL, Fliser D, Raj DS. Association of vascular endothelial factors with cardiovascular outcome and mortality in chronic kidney disease patients: a 4-year cohort study. Atherosclerosis. 2014 Oct;236(2):360-5. doi: 10.1016/j.atherosclerosis.2014.07.026. Epub 2014 Aug 12.
- Background: PubMed 15385656Go AS, Chertow GM, Fan D, McCulloch CE, Hsu CY. Chronic kidney disease and the risks of death, cardiovascular events, and hospitalization. N Engl J Med. 2004 Sep 23;351(13):1296-305. doi: 10.1056/NEJMoa041031.
- Background: PubMed 21393492Debella YT, Giduma HD, Light RP, Agarwal R. Chronic kidney disease as a coronary disease equivalent--a comparison with diabetes over a decade. Clin J Am Soc Nephrol. 2011 Jun;6(6):1385-92. doi: 10.2215/CJN.10271110. Epub 2011 Mar 10.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rebecca J. Ellis, PhD principal investigator
Indiana University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SystemCHANGE (TM) in people with Chronic Kidney Disease(CKD), run by Indiana University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Daily Doses of Medication Taken as Prescribed (Medication Adherence) (time frame: 8 Weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04616612, which also lists 50 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2025; AzTrials last refreshed its copy on 6 Nov 2026.