Chronic Kidney Disease(CKD)
Conditions
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.
Interventions
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.
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.
Sponsors
Study design
Intervention model description
Two-group, randomized, controlled trial
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Daily Doses of Medication Taken as Prescribed (Medication Adherence) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Qualitatively Analyzed From the Investigator-designed 10-item Acceptability Questionnaire Which Assesses Nurse-intervention Interaction and Mobile Technology Acceptability. | 12 weeks | Response options ranging from 5 (strongly agree) to 1 (strongly disagree). There is no total score. Depending on question strongly agree or strongly disagree may be related to better acceptability of the intervention. Answers on this survey guided development of individual interview questions to be qualitatively evaluated. The items on the Acceptability Scale, for example, had response options ranging from 5 (strongly agree) to 1 (strongly disagree). If a person indicated strong agreement with the item Getting messages on the mobile phone helps support my health behaviors, we would develop interview questions to read You indicated on your survey that getting messages on your phone supported your health behaviors. Tell me what behaviors the messages supported? Give me an example one of these behaviors. |
| Outcome Expectancy Questionnaire | 8 Weeks | This questionnaire measures the affective or emotional aspect of the client's expectations regarding improvement. It asks how much the client expects to improve as a result of the intervention. This is related to the client's emotional responses and affective processes, capturing their hopeful anticipation or optimism about the intervention outcomes. Higher scores indicate greater belief that the program will be beneficial. For outcome expectancy, the three questions will indicate how much they 1) think and 2) feel the program will help improve medication-taking using a 0 to 10 scale where 0 is no change and 10 is complete improvement, and how much they 3) feel it will reduce missing or taking medications late using 0 (the intervention won't help to reduce missed doses) to 10 (I won't miss any doses). Responses to the three questions are standardized and summed to create a total subscale score (range 0-30). |
| Credibility Questionnaire | 8 weeks | This questionnaire measures the logical and cognitive evaluation of the treatment. It assesses how credible or believable the treatment seems to the client. Questions on this scale typically ask about the perceived scientific legitimacy, logic, and reliability of the treatment. It taps into the client's rational thought processes and their cognitive appraisal of the treatment's potential effectiveness. Scores on the 3 questions indicate belief the program is credible. For treatment credibility items, participants indicate how 1) logical the program is and 2) how successfully they think it will help prevent missing or taking medications late, and 3) confidence recommending it to a friend all on a 0 to 10 scale and where 0 not logical, not credible, and participant is not confident in recommending to a friend to 10 logical, credible, and would recommend to a friend. Responses are standardized and summed to create a total subscale score on the three questions for a range of 0-30. |
| Personal Systems Thinking | 8 Weeks | 20-item Systems Thinking Scale (adapted for patients) was totaled from a 5-point scale (Never, Seldom, Some of the time, Often, Most of the time). Range 20 (personal motivation) -100 (system level thinking). This survey assesses participants view of behavior from a personal (motivation) level to a system (environmental) level. This scale evaluates intervention to improve systems thinking away from a personal motivational thinking. The total score was calculated to evaluate how thinking changed from baseline to 8 weeks and 12 weeks between the groups. Dolansky, M. A., et. al (2020). |
Countries
United States
Participant flow
Pre-assignment details
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)
Participants by arm
| Arm | Count |
|---|---|
| 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 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. | 10 |
| Attention Control 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. | 12 |
| Total | 22 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 6 | 3 |
Baseline characteristics
| Characteristic | SystemCHANGE (TM) | Total | Attention Control |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 6 Participants | 9 Participants | 3 Participants |
| Age, Categorical Between 18 and 65 years | 4 Participants | 13 Participants | 9 Participants |
| Age, Continuous | 69.5 years STANDARD_DEVIATION 9.1 | 64.0 years STANDARD_DEVIATION 9.59 | 59.4 years STANDARD_DEVIATION 7.56 |
| CKD etiology Diabetes | 0 Participants | 4 Participants | 4 Participants |
| CKD etiology Focal segmental glomerulosclerosis (FSGS) | 0 Participants | 1 Participants | 1 Participants |
| CKD etiology Hypertension | 3 Participants | 4 Participants | 1 Participants |
| CKD etiology Not documented | 7 Participants | 12 Participants | 5 Participants |
| CKD etiology Sickle Cell | 0 Participants | 1 Participants | 1 Participants |
| CKD Stage Stage 1 | 0 Participants | 0 Participants | 0 Participants |
| CKD Stage Stage 2 | 0 Participants | 2 Participants | 2 Participants |
| CKD Stage Stage 3a | 4 Participants | 11 Participants | 7 Participants |
| CKD Stage Stage 3b | 3 Participants | 5 Participants | 2 Participants |
| CKD Stage Stage 4 | 3 Participants | 4 Participants | 1 Participants |
| Co-morbidities Diabetes | 8 Participants | 17 Participants | 9 Participants |
| Co-morbidities Hypertension | 10 Participants | 21 Participants | 11 Participants |
| Education College Graduate or Higher | 5 Participants | 5 Participants | 0 Participants |
| Education High school graduate | 1 Participants | 4 Participants | 3 Participants |
| Education Less than high school | 1 Participants | 1 Participants | 0 Participants |
| Education Some college | 3 Participants | 10 Participants | 7 Participants |
| Education Some high school | 0 Participants | 2 Participants | 2 Participants |
| Employment Status Disabled | 2 Participants | 6 Participants | 4 Participants |
| Employment Status Employed Full Time | 1 Participants | 5 Participants | 4 Participants |
| Employment Status Employed Part Time | 0 Participants | 1 Participants | 1 Participants |
| Employment Status Retired | 7 Participants | 10 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 2 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 9 Participants | 19 Participants | 10 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 0 Participants |
| Income $25,000 to $50,000/ yr | 0 Participants | 3 Participants | 3 Participants |
| Income Less than $25,000/yr | 5 Participants | 9 Participants | 4 Participants |
| Income Over $50,000/yr | 4 Participants | 8 Participants | 4 Participants |
| Income Refuse to Answer | 1 Participants | 2 Participants | 1 Participants |
| Insurance Coverage Don't Know | 1 Participants | 1 Participants | 0 Participants |
| Insurance Coverage Medicaid | 3 Participants | 9 Participants | 6 Participants |
| Insurance Coverage Medicare | 5 Participants | 9 Participants | 4 Participants |
| Insurance Coverage Medicare plus a supplementary policy | 2 Participants | 2 Participants | 0 Participants |
| Insurance Coverage Military/ VA | 0 Participants | 0 Participants | 0 Participants |
| Insurance Coverage Other | 1 Participants | 3 Participants | 2 Participants |
| Insurance Coverage Private Health Insurance | 1 Participants | 6 Participants | 5 Participants |
| Insurance Coverage Refuse to Answer | 0 Participants | 0 Participants | 0 Participants |
| Marital Status Divorced | 2 Participants | 7 Participants | 5 Participants |
| Marital Status Married | 2 Participants | 4 Participants | 2 Participants |
| Marital Status Never Married | 3 Participants | 7 Participants | 4 Participants |
| Marital Status Widowed | 3 Participants | 4 Participants | 1 Participants |
| Number of Prescribed Daily Medications | 8.8 Number of Prescribed Medications | 9.7 Number of Prescribed Medications | 10.4 Number of Prescribed Medications |
| Over the counter medication | 2.5 Number of OTC Medications | 2 Number of OTC Medications | 1.5 Number of OTC Medications |
| Perceived Health Status Excellent | 1 Participants | 1 Participants | 0 Participants |
| Perceived Health Status Good/Fair | 7 Participants | 16 Participants | 9 Participants |
| Perceived Health Status Poor | 1 Participants | 2 Participants | 1 Participants |
| Perceived Health Status Very Good | 1 Participants | 3 Participants | 2 Participants |
| Perceived Health Status Very Poor | 0 Participants | 0 Participants | 0 Participants |
| Pill Box Usage No | 5 Participants | 13 Participants | 8 Participants |
| Pill Box Usage Yes | 5 Participants | 9 Participants | 4 Participants |
| Pre-Trial Medication Adherence (8 Weeks-Screening) | 83 Percentage STANDARD_DEVIATION 9 | 72 Percentage STANDARD_DEVIATION 17 | 65 Percentage STANDARD_DEVIATION 18 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants | 15 Participants | 9 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 4 Participants | 6 Participants | 2 Participants |
| Region of Enrollment United States | 10 participants | 22 participants | 12 participants |
| Sex: Female, Male Female | 5 Participants | 7 Participants | 2 Participants |
| Sex: Female, Male Male | 5 Participants | 15 Participants | 10 Participants |
| Systems Thinking Scale | 66 units on a scale STANDARD_DEVIATION 17.06 | 70.16 units on a scale STANDARD_DEVIATION 16.11 | 70.92 units on a scale STANDARD_DEVIATION 17.52 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 0 / 12 |
| other Total, other adverse events | 0 / 10 | 0 / 12 |
| serious Total, serious adverse events | 0 / 10 | 0 / 12 |
Outcome results
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.
Time frame: 12 Weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SystemCHANGE (TM) | Percentage of Daily Doses of Medication Taken as Prescribed (Medication Adherence) | 91 percentage of Daily doses | Standard Deviation 9 |
| Attention Control | Percentage of Daily Doses of Medication Taken as Prescribed (Medication Adherence) | 59 percentage of Daily doses | Standard Deviation 26 |
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.
Time frame: 8 Weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SystemCHANGE (TM) | Percentage of Daily Doses of Medication Taken as Prescribed (Medication Adherence) | 98 percentage of Daily doses | Standard Deviation 2 |
| Attention Control | Percentage of Daily Doses of Medication Taken as Prescribed (Medication Adherence) | 74 percentage of Daily doses | Standard Deviation 17 |
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.
Time frame: 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SystemCHANGE (TM) | Credibility Questionnaire | 28.67 score on a scale | Standard Deviation 1.37 |
| Attention Control | Credibility Questionnaire | 25.56 score on a scale | Standard Deviation 3.5 |
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.
Time frame: 12 Weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SystemCHANGE (TM) | Credibility Questionnaire | 26.67 score on a scale | Standard Deviation 4.37 |
| Attention Control | Credibility Questionnaire | 25.89 score on a scale | Standard Deviation 4.86 |
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.
Time frame: 12 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SystemCHANGE (TM) | Number of Participants Qualitatively Analyzed From the Investigator-designed 10-item Acceptability Questionnaire Which Assesses Nurse-intervention Interaction and Mobile Technology Acceptability. | 6 Participants |
| Attention Control | Number of Participants Qualitatively Analyzed From the Investigator-designed 10-item Acceptability Questionnaire Which Assesses Nurse-intervention Interaction and Mobile Technology Acceptability. | 8 Participants |
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).
Time frame: 12 Weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SystemCHANGE (TM) | Outcome Expectancy Questionnaire | 26.83 score on a scale | Standard Deviation 3.13 |
| Attention Control | Outcome Expectancy Questionnaire | 24.57 score on a scale | Standard Deviation 7.04 |
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).
Time frame: 8 Weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SystemCHANGE (TM) | Outcome Expectancy Questionnaire | 29 score on a scale | Standard Deviation 1.3 |
| Attention Control | Outcome Expectancy Questionnaire | 23.7 score on a scale | Standard Deviation 5.6 |
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).
Time frame: 8 Weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SystemCHANGE (TM) | Personal Systems Thinking | 68.5 score on a scale | Standard Deviation 15.06 |
| Attention Control | Personal Systems Thinking | 69.5 score on a scale | Standard Deviation 18.51 |
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).
Time frame: 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SystemCHANGE (TM) | Personal Systems Thinking | 64.11 score on a scale | Standard Deviation 13.27 |
| Attention Control | Personal Systems Thinking | 76.17 score on a scale | Standard Deviation 15.68 |