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

Chronic Kidney Disease(CKD) Clinical Trial

— MAGICIAN  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04616612
• Other study ID #: 2001957718
• Secondary ID: R21NR019348-02
• Status: Completed
• Phase: N/A
• Start date: December 15, 2021
• Est. completion date: February 6, 2024

Study information

• Verified date: May 2024
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: February 6, 2024
• Est. primary completion date: February 6, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Kidney Disease(CKD)
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Behavioral:
• 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.

Other:
• 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.

Locations

Country	Name	City	State
United States	Indiana University School of Nursing	Indianapolis	Indiana

Sponsors (2)

Lead Sponsor	Collaborator
Indiana University	National Institute of Nursing Research (NINR)

Country where clinical trial is conducted

United States, 

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* Note: There are 50 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	Up to 8 Weeks
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.	Up to 12 Weeks
Primary	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.	Change from Baseline to 12 weeks
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.	Baseline
Secondary	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.	12 weeks
Secondary	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.	Change from Baseline to 8 Weeks
Secondary	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.	Change from Baseline to 12 Weeks