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| ID | Type | Description | Link |
|---|---|---|---|
| R21NR019348-02 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Nursing Research (NINR) | NIH |
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The purpose of this 2-group, randomized, controlled trial is to evaluate the refined SystemCHANGEâ„¢ against attention control patient education in CKD patients taking RAAS medications.
In this study, the investigators will test a refined SystemCHANGEâ„¢ 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SystemCHANGE (TM) | Experimental | SystemCHANGEâ„¢ 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. SystemCHANGEâ„¢ 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 | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SystemCHANGE (TM) | Behavioral | Participants randomized to the refined SystemCHANGEâ„¢ 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 12 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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." |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rebecca J. Ellis, PhD | Indiana University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Indiana University School of Nursing | Indianapolis | Indiana | 46202 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27438073 | Background | 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. | |
| 20471734 | Background | Muntner 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. |
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| ID | Type | URL | Comment |
|---|---|---|---|
| Statistics | View IPD |
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)
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| ID | Title | Description |
|---|---|---|
| FG000 | SystemCHANGE (TM) | SystemCHANGEâ„¢ 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. SystemCHANGEâ„¢ 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 SystemCHANGEâ„¢ 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | SystemCHANGE (TM) | SystemCHANGEâ„¢ 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. SystemCHANGEâ„¢ 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 SystemCHANGEâ„¢ 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | percentage of Daily doses | 8 Weeks |
|
Participants were monitored for adverse events weekly from 0-8 weeks and then again at 12 weeks.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | SystemCHANGE (TM) | SystemCHANGEâ„¢ 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. SystemCHANGEâ„¢ 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 SystemCHANGEâ„¢ 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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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Rebecca Bartlett Ellis | Indiana University | 3172740047 | rjbartle@iu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 31, 2023 | Jan 30, 2025 | Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 9, 2020 | Feb 26, 2025 | SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 31, 2023 | May 6, 2024 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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Two-group, randomized, controlled trial
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|
| Attention Control | Other | 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 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). | 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). | 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. | 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. | 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). | 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). | 12 weeks |
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| Result | Bronfenbrenner U. The ecology of human development: Experiments by design and nature. In: Cambridge, MA: Harvard University Press; 1979. |
| Result | Deming E., Orsini J. The Essential Deming: Leadership Principles from the Father of Quality. New York, NY: McGraw-Hill Education; 2012. |
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. |
| Clinical Study Report | View IPD | 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. |
| Clinical Study Report | View IPD | 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. |
| Pamphlet | View IPD | U.S. Department of Health and Human Services. National Institutes of Health. In Brief: Your Guide to Healthy Sleep. In. Vol NIH Publication No. 11-5800. Bethesda, MA: NHLBI Health Information Center; 2011:1-4. |
| Education | View IPD | 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. |
| Education | View IPD | 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. |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Co-morbidities | Count of Participants | Participants |
|
| CKD Stage | During recruitment, collected participant data included stage of chronic kidney disease (CKD), gathered from clinical notes of providing nephrology practitioner. This study was open to those who were in CKD stages 1-4 (better to worse) as defined by kidney disease: Improving global outcomes (KDIGO) and the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) guidelines. CKD is defined as kidney damage where the staging is based on glomerular filtration rate (GFR) range: 1 (normal to high (>90 ml/min/1.73m2) stage 2 (60-89), stage 3a (45-59), 3b (30-44), and stage 4 (15-29). | Count of Participants | Participants |
|
| CKD etiology | Count of Participants | Participants |
|
| Marital Status | Count of Participants | Participants |
|
| Employment Status | Count of Participants | Participants |
|
| Education | Count of Participants | Participants |
|
| Income | Count of Participants | Participants |
|
| Insurance Coverage | Count of Participants | Participants |
|
| Pill Box Usage | Does participant use a pill box for their medications? | Count of Participants | Participants |
|
| Number of Prescribed Daily Medications | Mean | Full Range | Number of Prescribed Medications |
|
| Over the counter medication | Average number of over the counter (non-prescription) medications taken on a regular basis within the last three months, such as analgesics, allergy medications, etc. (A "regular basis" can be considered medications which are taken more than once per week) | Mean | Full Range | Number of OTC Medications |
|
| Perceived Health Status | Participants self-rated perceived health | Count of Participants | Participants |
|
| Pre-Trial Medication Adherence (8 Weeks-Screening) | 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. Scale is 0-100% | Mean | Standard Deviation | Percentage |
|
| Systems Thinking Scale | 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). | Row population differs as 7 did not complete baseline systems thinking due to lost to follow up before intervention started. | Mean | Standard Deviation | units on a scale |
|
| OG001 | 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. |
|
|
|
| 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. | Posted | Mean | Standard Deviation | percentage of Daily doses | 12 Weeks |
|
|
|
|
| Secondary | 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." | Posted | Count of Participants | Participants | 12 weeks |
|
|
|
|
| Secondary | 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). | Posted | Mean | Standard Deviation | score on a scale | 8 Weeks |
|
|
|
|
| Secondary | 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). | Posted | Mean | Standard Deviation | score on a scale | 12 Weeks |
|
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | 8 weeks |
|
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | 12 Weeks |
|
|
|
|
| Secondary | 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). | Posted | Mean | Standard Deviation | score on a scale | 8 Weeks |
|
|
|
|
| Secondary | 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). | Posted | Mean | Standard Deviation | score on a scale | 12 weeks |
|
|
|
|
| 0 |
| 10 |
| 0 |
| 10 |
| 0 |
| 10 |
| EG001 | 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. | 0 | 12 | 0 | 12 | 0 | 12 |
Not provided
Not provided
Not provided
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Stage 3a |
|
| Stage 3b |
|
| Stage 4 |
|
| Not documented |
|
| Sickle Cell |
|
| Focal segmental glomerulosclerosis (FSGS) |
|
| Married |
|
| Widowed |
|
| Employed Full Time |
|
| Employed Part Time |
|
| High school graduate |
|
| Some college |
|
| College Graduate or Higher |
|
| Over $50,000/yr |
|
| Refuse to Answer |
|
| Good/Fair |
|
| Poor |
|
| Very Poor |
|