Trial Outcomes & Findings for Medication Adherence Given Individual SystemCHANGE(TM) in Advancing Nephropathy (MAGICIAN) Pilot Study (NCT NCT04616612)
NCT ID: NCT04616612
Last Updated: 2025-04-23
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
150 participants
Primary outcome timeframe
8 Weeks
Results posted on
2025-04-23
Participant Flow
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)
Participant milestones
| Measure |
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 received 7 personalized sessions with a nurse-interventionist (session 1 virtual face-to-face, sessions 2-7 via phone) and 8 weekly feedback MMS message reports delivered to mobile phones.
|
Attention Control
Participants in the attention control received educational materials about chronic kidney disease (CKD). The content will be focused on diet, exercise, and stress management 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 received 7 personalized sessions with a nurse-interventionist (session 1 virtual face-to-face, sessions 2-7 via phone) and 8 weekly educational MMS messages delivered to mobile phones.
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
12
|
|
Overall Study
COMPLETED
|
4
|
9
|
|
Overall Study
NOT COMPLETED
|
6
|
3
|
Reasons for withdrawal
| Measure |
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 received 7 personalized sessions with a nurse-interventionist (session 1 virtual face-to-face, sessions 2-7 via phone) and 8 weekly feedback MMS message reports delivered to mobile phones.
|
Attention Control
Participants in the attention control received educational materials about chronic kidney disease (CKD). The content will be focused on diet, exercise, and stress management 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 received 7 personalized sessions with a nurse-interventionist (session 1 virtual face-to-face, sessions 2-7 via phone) and 8 weekly educational MMS messages delivered to mobile phones.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
6
|
3
|
Baseline Characteristics
Row population differs as 7 did not complete baseline systems thinking due to lost to follow up before intervention started.
Baseline characteristics by cohort
| Measure |
SystemCHANGE (TM)
n=10 Participants
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.
|
Attention Control
n=12 Participants
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.
|
Total
n=22 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=10 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=22 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=10 Participants
|
9 Participants
n=12 Participants
|
13 Participants
n=22 Participants
|
|
Age, Categorical
>=65 years
|
6 Participants
n=10 Participants
|
3 Participants
n=12 Participants
|
9 Participants
n=22 Participants
|
|
Age, Continuous
|
69.5 years
STANDARD_DEVIATION 9.1 • n=10 Participants
|
59.4 years
STANDARD_DEVIATION 7.56 • n=12 Participants
|
64.0 years
STANDARD_DEVIATION 9.59 • n=22 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=10 Participants
|
2 Participants
n=12 Participants
|
7 Participants
n=22 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=10 Participants
|
10 Participants
n=12 Participants
|
15 Participants
n=22 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=10 Participants
|
2 Participants
n=12 Participants
|
2 Participants
n=22 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
9 Participants
n=10 Participants
|
10 Participants
n=12 Participants
|
19 Participants
n=22 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=10 Participants
|
0 Participants
n=12 Participants
|
1 Participants
n=22 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=10 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=22 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=10 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=22 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=10 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=22 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=10 Participants
|
9 Participants
n=12 Participants
|
15 Participants
n=22 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=10 Participants
|
2 Participants
n=12 Participants
|
6 Participants
n=22 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=10 Participants
|
1 Participants
n=12 Participants
|
1 Participants
n=22 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=10 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=22 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=10 Participants
|
12 participants
n=12 Participants
|
22 participants
n=22 Participants
|
|
Co-morbidities
Hypertension
|
10 Participants
n=10 Participants
|
11 Participants
n=12 Participants
|
21 Participants
n=22 Participants
|
|
Co-morbidities
Diabetes
|
8 Participants
n=10 Participants
|
9 Participants
n=12 Participants
|
17 Participants
n=22 Participants
|
|
CKD Stage
Stage 1
|
0 Participants
n=10 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=22 Participants
|
|
CKD Stage
Stage 2
|
0 Participants
n=10 Participants
|
2 Participants
n=12 Participants
|
2 Participants
n=22 Participants
|
|
CKD Stage
Stage 3a
|
4 Participants
n=10 Participants
|
7 Participants
n=12 Participants
|
11 Participants
n=22 Participants
|
|
CKD Stage
Stage 3b
|
3 Participants
n=10 Participants
|
2 Participants
n=12 Participants
|
5 Participants
n=22 Participants
|
|
CKD Stage
Stage 4
|
3 Participants
n=10 Participants
|
1 Participants
n=12 Participants
|
4 Participants
n=22 Participants
|
|
CKD etiology
Diabetes
|
0 Participants
n=10 Participants
|
4 Participants
n=12 Participants
|
4 Participants
n=22 Participants
|
|
CKD etiology
Hypertension
|
3 Participants
n=10 Participants
|
1 Participants
n=12 Participants
|
4 Participants
n=22 Participants
|
|
CKD etiology
Not documented
|
7 Participants
n=10 Participants
|
5 Participants
n=12 Participants
|
12 Participants
n=22 Participants
|
|
CKD etiology
Sickle Cell
|
0 Participants
n=10 Participants
|
1 Participants
n=12 Participants
|
1 Participants
n=22 Participants
|
|
CKD etiology
Focal segmental glomerulosclerosis (FSGS)
|
0 Participants
n=10 Participants
|
1 Participants
n=12 Participants
|
1 Participants
n=22 Participants
|
|
Marital Status
Divorced
|
2 Participants
n=10 Participants
|
5 Participants
n=12 Participants
|
7 Participants
n=22 Participants
|
|
Marital Status
Never Married
|
3 Participants
n=10 Participants
|
4 Participants
n=12 Participants
|
7 Participants
n=22 Participants
|
|
Marital Status
Married
|
2 Participants
n=10 Participants
|
2 Participants
n=12 Participants
|
4 Participants
n=22 Participants
|
|
Marital Status
Widowed
|
3 Participants
n=10 Participants
|
1 Participants
n=12 Participants
|
4 Participants
n=22 Participants
|
|
Employment Status
Retired
|
7 Participants
n=10 Participants
|
3 Participants
n=12 Participants
|
10 Participants
n=22 Participants
|
|
Employment Status
Disabled
|
2 Participants
n=10 Participants
|
4 Participants
n=12 Participants
|
6 Participants
n=22 Participants
|
|
Employment Status
Employed Full Time
|
1 Participants
n=10 Participants
|
4 Participants
n=12 Participants
|
5 Participants
n=22 Participants
|
|
Employment Status
Employed Part Time
|
0 Participants
n=10 Participants
|
1 Participants
n=12 Participants
|
1 Participants
n=22 Participants
|
|
Education
Less than high school
|
1 Participants
n=10 Participants
|
0 Participants
n=12 Participants
|
1 Participants
n=22 Participants
|
|
Education
Some high school
|
0 Participants
n=10 Participants
|
2 Participants
n=12 Participants
|
2 Participants
n=22 Participants
|
|
Education
High school graduate
|
1 Participants
n=10 Participants
|
3 Participants
n=12 Participants
|
4 Participants
n=22 Participants
|
|
Education
Some college
|
3 Participants
n=10 Participants
|
7 Participants
n=12 Participants
|
10 Participants
n=22 Participants
|
|
Education
College Graduate or Higher
|
5 Participants
n=10 Participants
|
0 Participants
n=12 Participants
|
5 Participants
n=22 Participants
|
|
Income
Less than $25,000/yr
|
5 Participants
n=10 Participants
|
4 Participants
n=12 Participants
|
9 Participants
n=22 Participants
|
|
Income
$25,000 to $50,000/ yr
|
0 Participants
n=10 Participants
|
3 Participants
n=12 Participants
|
3 Participants
n=22 Participants
|
|
Income
Over $50,000/yr
|
4 Participants
n=10 Participants
|
4 Participants
n=12 Participants
|
8 Participants
n=22 Participants
|
|
Income
Refuse to Answer
|
1 Participants
n=10 Participants
|
1 Participants
n=12 Participants
|
2 Participants
n=22 Participants
|
|
Insurance Coverage
Medicare
|
5 Participants
n=10 Participants
|
4 Participants
n=12 Participants
|
9 Participants
n=22 Participants
|
|
Insurance Coverage
Medicare plus a supplementary policy
|
2 Participants
n=10 Participants
|
0 Participants
n=12 Participants
|
2 Participants
n=22 Participants
|
|
Insurance Coverage
Military/ VA
|
0 Participants
n=10 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=22 Participants
|
|
Insurance Coverage
Medicaid
|
3 Participants
n=10 Participants
|
6 Participants
n=12 Participants
|
9 Participants
n=22 Participants
|
|
Insurance Coverage
Private Health Insurance
|
1 Participants
n=10 Participants
|
5 Participants
n=12 Participants
|
6 Participants
n=22 Participants
|
|
Insurance Coverage
Don't Know
|
1 Participants
n=10 Participants
|
0 Participants
n=12 Participants
|
1 Participants
n=22 Participants
|
|
Insurance Coverage
Other
|
1 Participants
n=10 Participants
|
2 Participants
n=12 Participants
|
3 Participants
n=22 Participants
|
|
Insurance Coverage
Refuse to Answer
|
0 Participants
n=10 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=22 Participants
|
|
Pill Box Usage
Yes
|
5 Participants
n=10 Participants
|
4 Participants
n=12 Participants
|
9 Participants
n=22 Participants
|
|
Pill Box Usage
No
|
5 Participants
n=10 Participants
|
8 Participants
n=12 Participants
|
13 Participants
n=22 Participants
|
|
Number of Prescribed Daily Medications
|
8.8 Number of Prescribed Medications
n=10 Participants
|
10.4 Number of Prescribed Medications
n=12 Participants
|
9.7 Number of Prescribed Medications
n=22 Participants
|
|
Over the counter medication
|
2.5 Number of OTC Medications
n=10 Participants
|
1.5 Number of OTC Medications
n=12 Participants
|
2 Number of OTC Medications
n=22 Participants
|
|
Perceived Health Status
Excellent
|
1 Participants
n=10 Participants
|
0 Participants
n=12 Participants
|
1 Participants
n=22 Participants
|
|
Perceived Health Status
Very Good
|
1 Participants
n=10 Participants
|
2 Participants
n=12 Participants
|
3 Participants
n=22 Participants
|
|
Perceived Health Status
Good/Fair
|
7 Participants
n=10 Participants
|
9 Participants
n=12 Participants
|
16 Participants
n=22 Participants
|
|
Perceived Health Status
Poor
|
1 Participants
n=10 Participants
|
1 Participants
n=12 Participants
|
2 Participants
n=22 Participants
|
|
Perceived Health Status
Very Poor
|
0 Participants
n=10 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=22 Participants
|
|
Pre-Trial Medication Adherence (8 Weeks-Screening)
|
83 Percentage
STANDARD_DEVIATION 9 • n=10 Participants
|
65 Percentage
STANDARD_DEVIATION 18 • n=12 Participants
|
72 Percentage
STANDARD_DEVIATION 17 • n=22 Participants
|
|
Systems Thinking Scale
|
66 units on a scale
STANDARD_DEVIATION 17.06 • n=6 Participants • Row population differs as 7 did not complete baseline systems thinking due to lost to follow up before intervention started.
|
70.92 units on a scale
STANDARD_DEVIATION 17.52 • n=9 Participants • Row population differs as 7 did not complete baseline systems thinking due to lost to follow up before intervention started.
|
70.16 units on a scale
STANDARD_DEVIATION 16.11 • n=15 Participants • Row population differs as 7 did not complete baseline systems thinking due to lost to follow up before intervention started.
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
SystemCHANGE (TM)
n=6 Participants
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 received 7 personalized sessions with a nurse-interventionist (session 1 virtual face-to-face, sessions 2-7 via phone) and 8 weekly feedback MMS message reports delivered to mobile phones.
|
Attention Control
n=8 Participants
Participants in the attention control received educational materials about chronic kidney disease (CKD). The content will be focused on diet, exercise, and stress management 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 received 7 personalized sessions with a nurse-interventionist (session 1 virtual face-to-face, sessions 2-7 via phone) and 8 weekly educational MMS messages delivered to mobile phones.
|
|---|---|---|
|
Percentage of Daily Doses of Medication Taken as Prescribed (Medication Adherence)
|
98 percentage of Daily doses
Standard Deviation 2
|
74 percentage of Daily doses
Standard Deviation 17
|
PRIMARY outcome
Timeframe: 12 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.
Outcome measures
| Measure |
SystemCHANGE (TM)
n=6 Participants
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 received 7 personalized sessions with a nurse-interventionist (session 1 virtual face-to-face, sessions 2-7 via phone) and 8 weekly feedback MMS message reports delivered to mobile phones.
|
Attention Control
n=8 Participants
Participants in the attention control received educational materials about chronic kidney disease (CKD). The content will be focused on diet, exercise, and stress management 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 received 7 personalized sessions with a nurse-interventionist (session 1 virtual face-to-face, sessions 2-7 via phone) and 8 weekly educational MMS messages delivered to mobile phones.
|
|---|---|---|
|
Percentage of Daily Doses of Medication Taken as Prescribed (Medication Adherence)
|
91 percentage of Daily doses
Standard Deviation 9
|
59 percentage of Daily doses
Standard Deviation 26
|
SECONDARY outcome
Timeframe: 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 measures
| Measure |
SystemCHANGE (TM)
n=6 Participants
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 received 7 personalized sessions with a nurse-interventionist (session 1 virtual face-to-face, sessions 2-7 via phone) and 8 weekly feedback MMS message reports delivered to mobile phones.
|
Attention Control
n=8 Participants
Participants in the attention control received educational materials about chronic kidney disease (CKD). The content will be focused on diet, exercise, and stress management 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 received 7 personalized sessions with a nurse-interventionist (session 1 virtual face-to-face, sessions 2-7 via phone) and 8 weekly educational MMS messages delivered to mobile phones.
|
|---|---|---|
|
Number of Participants Qualitatively Analyzed From the Investigator-designed 10-item Acceptability Questionnaire Which Assesses Nurse-intervention Interaction and Mobile Technology Acceptability.
|
6 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: 8 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).
Outcome measures
| Measure |
SystemCHANGE (TM)
n=6 Participants
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 received 7 personalized sessions with a nurse-interventionist (session 1 virtual face-to-face, sessions 2-7 via phone) and 8 weekly feedback MMS message reports delivered to mobile phones.
|
Attention Control
n=9 Participants
Participants in the attention control received educational materials about chronic kidney disease (CKD). The content will be focused on diet, exercise, and stress management 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 received 7 personalized sessions with a nurse-interventionist (session 1 virtual face-to-face, sessions 2-7 via phone) and 8 weekly educational MMS messages delivered to mobile phones.
|
|---|---|---|
|
Outcome Expectancy Questionnaire
|
29 score on a scale
Standard Deviation 1.3
|
23.7 score on a scale
Standard Deviation 5.6
|
SECONDARY outcome
Timeframe: 12 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).
Outcome measures
| Measure |
SystemCHANGE (TM)
n=6 Participants
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 received 7 personalized sessions with a nurse-interventionist (session 1 virtual face-to-face, sessions 2-7 via phone) and 8 weekly feedback MMS message reports delivered to mobile phones.
|
Attention Control
n=9 Participants
Participants in the attention control received educational materials about chronic kidney disease (CKD). The content will be focused on diet, exercise, and stress management 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 received 7 personalized sessions with a nurse-interventionist (session 1 virtual face-to-face, sessions 2-7 via phone) and 8 weekly educational MMS messages delivered to mobile phones.
|
|---|---|---|
|
Outcome Expectancy Questionnaire
|
26.83 score on a scale
Standard Deviation 3.13
|
24.57 score on a scale
Standard Deviation 7.04
|
SECONDARY outcome
Timeframe: 8 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.
Outcome measures
| Measure |
SystemCHANGE (TM)
n=6 Participants
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 received 7 personalized sessions with a nurse-interventionist (session 1 virtual face-to-face, sessions 2-7 via phone) and 8 weekly feedback MMS message reports delivered to mobile phones.
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Attention Control
n=9 Participants
Participants in the attention control received educational materials about chronic kidney disease (CKD). The content will be focused on diet, exercise, and stress management 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 received 7 personalized sessions with a nurse-interventionist (session 1 virtual face-to-face, sessions 2-7 via phone) and 8 weekly educational MMS messages delivered to mobile phones.
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|---|---|---|
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Credibility Questionnaire
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28.67 score on a scale
Standard Deviation 1.37
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25.56 score on a scale
Standard Deviation 3.50
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SECONDARY outcome
Timeframe: 12 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.
Outcome measures
| Measure |
SystemCHANGE (TM)
n=6 Participants
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 received 7 personalized sessions with a nurse-interventionist (session 1 virtual face-to-face, sessions 2-7 via phone) and 8 weekly feedback MMS message reports delivered to mobile phones.
|
Attention Control
n=9 Participants
Participants in the attention control received educational materials about chronic kidney disease (CKD). The content will be focused on diet, exercise, and stress management 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 received 7 personalized sessions with a nurse-interventionist (session 1 virtual face-to-face, sessions 2-7 via phone) and 8 weekly educational MMS messages delivered to mobile phones.
|
|---|---|---|
|
Credibility Questionnaire
|
26.67 score on a scale
Standard Deviation 4.37
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25.89 score on a scale
Standard Deviation 4.86
|
SECONDARY outcome
Timeframe: 8 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).
Outcome measures
| Measure |
SystemCHANGE (TM)
n=6 Participants
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 received 7 personalized sessions with a nurse-interventionist (session 1 virtual face-to-face, sessions 2-7 via phone) and 8 weekly feedback MMS message reports delivered to mobile phones.
|
Attention Control
n=8 Participants
Participants in the attention control received educational materials about chronic kidney disease (CKD). The content will be focused on diet, exercise, and stress management 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 received 7 personalized sessions with a nurse-interventionist (session 1 virtual face-to-face, sessions 2-7 via phone) and 8 weekly educational MMS messages delivered to mobile phones.
|
|---|---|---|
|
Personal Systems Thinking
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68.5 score on a scale
Standard Deviation 15.06
|
69.5 score on a scale
Standard Deviation 18.51
|
SECONDARY outcome
Timeframe: 12 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).
Outcome measures
| Measure |
SystemCHANGE (TM)
n=6 Participants
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 received 7 personalized sessions with a nurse-interventionist (session 1 virtual face-to-face, sessions 2-7 via phone) and 8 weekly feedback MMS message reports delivered to mobile phones.
|
Attention Control
n=8 Participants
Participants in the attention control received educational materials about chronic kidney disease (CKD). The content will be focused on diet, exercise, and stress management 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 received 7 personalized sessions with a nurse-interventionist (session 1 virtual face-to-face, sessions 2-7 via phone) and 8 weekly educational MMS messages delivered to mobile phones.
|
|---|---|---|
|
Personal Systems Thinking
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64.11 score on a scale
Standard Deviation 13.27
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76.17 score on a scale
Standard Deviation 15.68
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Adverse Events
SystemCHANGE (TM)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Attention Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place