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

Primary Purpose

Chronic Kidney Disease(CKD)

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
SystemCHANGE (TM)
Attention Control
Sponsored by
Indiana University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Chronic Kidney Disease(CKD)

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Indiana University School of NursingRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

SystemCHANGE (TM)

Attention Control

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.
Change in Personal Systems Behavior
20-item Systems Thinking Survey (adapted for patients) on a 5-point Likert scale. This survey assesses if the participants view on behavior at a personal (motivation) or system level.
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.

Secondary Outcome Measures

The investigator-designed 10-item Acceptability Questionnaire assesses nurse-intervention interaction and mobility technology acceptability.
Response options ranging from 5 (strongly agree) to 1 (strongly disagree). Because this is an investigator designed assessment, will use individual item scores for analysis.
Outcome Expectancy and Credibility
Scores indicate greater belief that the program will be beneficial (outcome expectancy) or greater belief the program is credible (credibility). For outcome expectancy, participants will indicate how much they a) think and b) feel the program will help improve medication-taking using a 0% to 100% scale, and how much they c) feel it will reduce missing or taking medications late using response options from 1 (not at all) to 9 (very much). For treatment credibility items, participants indicate how a) logical the program is and b) how successfully they think it will help prevent missing or taking medications late, and c) confidence recommending it to a friend on a 1 to 9 scale and responses are standardized and summed to create a total subscale score.
Outcome Expectancy and Credibility
Scores indicate greater belief that the program will be beneficial (outcome expectancy) or greater belief the program is credible (credibility). For outcome expectancy, participants will indicate how much they a) think and b) feel the program will help improve medication-taking using a 0% to 100% scale, and how much they c) feel it will reduce missing or taking medications late using response options from 1 (not at all) to 9 (very much). For treatment credibility items, participants indicate how a) logical the program is and b) how successfully they think it will help prevent missing or taking medications late, and c) confidence recommending it to a friend on a 1 to 9 scale and responses are standardized and summed to create a total subscale score.

Full Information

First Posted
September 17, 2020
Last Updated
October 22, 2023
Sponsor
Indiana University
Collaborators
National Institute of Nursing Research (NINR)
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1. Study Identification

Unique Protocol Identification Number
NCT04616612
Brief Title
Medication Adherence Given Individual SystemCHANGE(TM) in Advancing Nephropathy (MAGICIAN) Pilot Study
Acronym
MAGICIAN
Official Title
Medication Adherence Given Individual SystemCHANGE(TM) in Advancing Nephropathy (MAGICIAN) Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 15, 2021 (Actual)
Primary Completion Date
April 1, 2024 (Anticipated)
Study Completion Date
April 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Indiana University
Collaborators
National Institute of Nursing Research (NINR)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease(CKD)

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Two-group, randomized, controlled trial
Masking
Care Provider
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
SystemCHANGE (TM)
Arm Type
Experimental
Arm Description
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.
Arm Title
Attention Control
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
SystemCHANGE (TM)
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Attention Control
Intervention Description
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 Outcome Measure Information:
Title
Percentage of daily doses of medication taken as prescribed (Medication Adherence)
Description
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
Up to 8 Weeks
Title
Percentage of daily doses of medication taken as prescribed (Medication Adherence)
Description
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
Up to 12 Weeks
Title
Change in Personal Systems Behavior
Description
20-item Systems Thinking Survey (adapted for patients) on a 5-point Likert scale. This survey assesses if the participants view on behavior at a personal (motivation) or system level.
Time Frame
Change from Baseline to 12 weeks
Title
Percentage of daily doses of medication taken as prescribed (Medication Adherence)
Description
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
Baseline
Secondary Outcome Measure Information:
Title
The investigator-designed 10-item Acceptability Questionnaire assesses nurse-intervention interaction and mobility technology acceptability.
Description
Response options ranging from 5 (strongly agree) to 1 (strongly disagree). Because this is an investigator designed assessment, will use individual item scores for analysis.
Time Frame
12 weeks
Title
Outcome Expectancy and Credibility
Description
Scores indicate greater belief that the program will be beneficial (outcome expectancy) or greater belief the program is credible (credibility). For outcome expectancy, participants will indicate how much they a) think and b) feel the program will help improve medication-taking using a 0% to 100% scale, and how much they c) feel it will reduce missing or taking medications late using response options from 1 (not at all) to 9 (very much). For treatment credibility items, participants indicate how a) logical the program is and b) how successfully they think it will help prevent missing or taking medications late, and c) confidence recommending it to a friend on a 1 to 9 scale and responses are standardized and summed to create a total subscale score.
Time Frame
Change from Baseline to 8 Weeks
Title
Outcome Expectancy and Credibility
Description
Scores indicate greater belief that the program will be beneficial (outcome expectancy) or greater belief the program is credible (credibility). For outcome expectancy, participants will indicate how much they a) think and b) feel the program will help improve medication-taking using a 0% to 100% scale, and how much they c) feel it will reduce missing or taking medications late using response options from 1 (not at all) to 9 (very much). For treatment credibility items, participants indicate how a) logical the program is and b) how successfully they think it will help prevent missing or taking medications late, and c) confidence recommending it to a friend on a 1 to 9 scale and responses are standardized and summed to create a total subscale score.
Time Frame
Change from Baseline to 12 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zvonar
Phone
3172744970
Email
szvonar@iu.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rebecca J. Ellis, PhD
Organizational Affiliation
Indiana University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Indiana University School of Nursing
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zvonar
Email
szvonar@iu.edu

12. IPD Sharing Statement

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Available IPD and Supporting Information:
Available IPD/Information Type
Clinical Study Report
Available IPD/Information URL
https://www.usrds.org/annual-data-report/current-adr/
Available IPD/Information Comments
United States Renal Data System. USRDS annual data report: Epidemiology of kidney disease in the United States. National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD. 2017.
Available IPD/Information Type
Statistics
Available IPD/Information URL
https://www.niddk.nih.gov/health-information/health-statistics/kidney-disease
Available IPD/Information Comments
US Department of Health & Human Services. Kidney disease statistics for the United States. Bethesda, MD: National Kidney and Urologic Diseases Information Clearinghouse, National Institutes of Health. 2011.
Available IPD/Information Type
Clinical Study Report
Available IPD/Information URL
https://kdigo.org/wp-content/uploads/2016/10/KDIGO-2012-Blood-Pressure-Guideline-English.pdf
Available IPD/Information Comments
KDIGO. Kidney Disease: Improving global outcomes blood pressure work group, KDIGO clinical practice guideline for the management of blood pressure in chronic kidney disease. Kidney International. 2012;Suppl. 2(5):337-414.
Available IPD/Information Type
Clinical Study Report
Available IPD/Information URL
https://www.niddk.nih.gov/
Available IPD/Information Comments
National Institute of Diabetes and Digestive and Kidney Diseases. High Blood Pressure and Kidney Disease. In. NIH Publication No. 14-4572 ed. Bethesda, MD: National Kidney and Urologic Diseases Information Clearinghouse (NKUDIC); 2014:12.
Available IPD/Information Type
Education
Available IPD/Information URL
https://www.kidney.org/nutrition/Kidney-Disease-Stages-1-4
Available IPD/Information Comments
National Kidney Foundation. Nutrition and Chronic Kidney Disease (Stages 1-4). Are You Getting What You Need? In. Vol 11-10-1811_HBE. 11-10-1811_HBE ed. New York, NY: National Kidney Foundation; 2013-2014:1-28.
Available IPD/Information Type
Education
Available IPD/Information URL
https://www.kidney.org/atoz/content/Diabetes-and-Kidney-Disease-Stages1-4
Available IPD/Information Comments
National Kidney Foundation. Hidden health risks: Kidney Disease, Diabetes, and High Blood Pressure. In. Vol 11-10-1811_HBE. New York, NY: National Kidney Foundation 2014:1-20.

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

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