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| Name | Class |
|---|---|
| Zuni Tribal Administration | UNKNOWN |
| Zuni comprehensive Community Health Center, Indian Health Services | UNKNOWN |
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People reach End Stage Renal Disease (ESRD) due to progressive chronic kidney disease (CKD). CKD is associated with increased risks for heart disease and death. The burden of chronic kidney disease is increased among minority populations compare to Caucasians. The Zuni Indians are experiencing an epidemic of chronic kidney disease is due primarily to the high rates of obesity and diabetes. The present study entitled Home-Based Kidney Care is designed to delay / reduce rate of ESRD by early interventions in CKD. Investigators propose to assess the safety and efficacy of conducting a full-scale study to determine if home based care delivered by a collaborative team composed of community health workers and University of New Mexico faculty will decrease the risk for the development and the progression of CKD.
Hypothesis: (1) The Zuni Health Initiative (ZHI) can integrate an innovative approach to Home based kidney care (HBKC) utilizing tribal Community Health Representatives (CHRs), Point of Care (POC) technology, telemedicine and motivational messaging in conjunction with patient preferences and Patient Activation Measures (PAM) into the chronic care model to improve the detection and treatment of Chronic Kidney Disease (CKD) and related risk factors; (2) This model is generalizable to other high-risk communities e.g., Hispanic and American Indians in Guadalupe, AZ being studied by NIDDK, NIH-Phoenix.
Specific Aim 1: Re-phenotype prior participants, to identify incident cases of CKD, estimate progression rates, and identify participants for the proposed study of HBKC;
Specific Aim 2: Conduct a pilot study of HBKC in 120 people. Randomize households in a 1:1 allocation to usual care versus HBKC. Compare the changes in Patient Activation measure (PAM), Adherence, BP, weight, HbA1c, UACR, eGFR and lipid profiles between the two groups over the 1-year intervention period;
Specific Aim 3: Inform the design of the full-scale study by estimating anticipated recruitment, adherence and dropout rates, sample size and reassessing the approach;
Specific Aim 4: Assess the exportability of the HBKC model to Hispanics and American Indians in Guadalupe, AZ.
Study Outcomes: (1) The PAM and adherence; (2) Changes in clinical phenotypes including Cr, UACR, A1c, body weight, BMI, fasting glucose, blood pressure (BP), plasma lipids, and inflammatory markers; (3) Changes in the quantitative traits such as diet and scores from a battery of mental-health, self-efficacy, and quality of life instruments.
Health Impact: The active participation of the Zuni tribal leadership and IHS in this protocol, and the general affordability of Zuni native CHR personnel, render the outcomes that will be demonstrated by this proposal easily sustainable over the long term. If successful, this program has the potential to change best-practices for CKD progression and to reduce health disparities in a cost-effective and sustainable manner.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Education and Lifestyle Coaching | Experimental | Education and life style coaching includes: education about diabetes and kidney disease Coaching /counseling about lifestyle, nutrition and medication adherence |
|
| Usual care (UC) control arm | No Intervention | once randomize to the Usual Care control group, the participants are left alone and are suggested to contact their providers for health care. The group gets labs and other survey done at 6 and 12 months of the intervention. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Educational and lifestyle coaching | Other | Educational lifestyle and patient activation is a CHR lead home visits every other week to provide education on healthy lifestyles (diet, exercise, alcohol abuse and smoking) as patient preference; Education provided on management of diabetes, hypertension and hyperlipidemia POC testing for A1C and microalbuminuria conducted at patient homes. Lifestyle and diet related Motivational messaging carried out regularly. Patient will receive group session at the clinic every quarters. Control arm will receive their usual care provided by IHS. The control group will receive a health evaluation at the initiation of the study and at the 6-month and 12-month. |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Activation Measure (PAM) -13 Item Questionnaire | Patient Activation Measure (PAM) questionnaire gives total score of activation as well as levels (stages) of patient activation. PAM total score can range form 0-100 with higher score reflecting higher level of activation in Patient health care. PAM levels (Stages) 1 through 4 with 1 being the lowest activation and 4 being the highest activation level. We collected data about Changes in PAM score as well as levels (stages) from baseline to 12 months of intervention and compare it to Usual care group. | 12 months follow-up minus baseline values |
| Patient Activation Measure (PAM) Level Greater Than 2 | Participants in an "Activated" category. Patient Activation Measure (PAM) questionnaire gives total score of activation as well as levels (stages) of patient activation. PAM total score can range form 0-100 with higher score reflecting higher level of activation in Patient health care. PAM levels (Stages) 1 through 4 with 1 being the lowest activation and 4 being the highest activation level. Level 1 labeled as patient being dis-engaged, Level 2 labeled as patient becoming aware of health condition but still struggling, level 3 labeled as patient is taking action and gaining control of their health care and level 4 labeled as maintaining behaviors and pushing forward - for our analysis purposes we classified participants into levels 3 and 4 (activated) and level 1 and 2 as not activated. We collected data about Changes in PAM score as well as levels (stages) from baseline to 12 months of intervention and compare it to Usual care group. | 12 months follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| A1c | Changes in clinical values | 12 months minus baseline values |
| Diastolic Blood Pressure | Changes in diastolic blood pressure on study. |
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Inclusion Criteria:
Exclusion Criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25954817 | Background | Shah VO, Carroll C, Mals R, Ghahate D, Bobelu J, Sandy P, Colleran K, Schrader R, Faber T, Burge MR. A Home-Based Educational Intervention Improves Patient Activation Measures and Diabetes Health Indicators among Zuni Indians. PLoS One. 2015 May 8;10(5):e0125820. doi: 10.1371/journal.pone.0125820. eCollection 2015. | |
| 24919064 | Background |
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Anonymized data will be available to share once the Zuni tribal leadership approves it.
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| ID | Title | Description |
|---|---|---|
| FG000 | Education and Lifestyle Coaching | Education and life style coaching includes: education about diabetes and kidney disease Coaching /counseling about lifestyle, nutrition and medication adherence Educational and lifestyle coaching: Educational lifestyle and patient activation is a CHR lead home visits every other week to provide education on healthy lifestyles (diet, exercise, alcohol abuse and smoking) as patient preference; Education provided on management of diabetes, hypertension and hyperlipidemia POC testing for A1C and microalbuminuria conducted at patient homes. Lifestyle and diet related Motivational messaging carried out regularly. Patient will receive group session at the clinic every quarters. Control arm will receive their usual care provided by IHS. The control group will receive a health evaluation at the initiation of the study and at the 6-month and 12-month. |
| FG001 | Usual Care (UC) Control Arm | once randomize to the Usual Care control group, the participants are left alone and are suggested to contact their providers for health care. The group gets labs and other survey done at 6 and 12 months of the intervention. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Members of the Zuni Pueblo, NM who have evidence of chronic kidney disease based on microalbuminuria of >30 mg/g
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| ID | Title | Description |
|---|---|---|
| BG000 | Education and Lifestyle Coaching | Education and life style coaching includes: education about diabetes and kidney disease Coaching /counseling about lifestyle, nutrition and medication adherence Educational and lifestyle coaching: Educational lifestyle and patient activation is a CHR lead home visits every other week to provide education on healthy lifestyles (diet, exercise, alcohol abuse and smoking) as patient preference; Education provided on management of diabetes, hypertension and hyperlipidemia POC testing for A1C and microalbuminuria conducted at patient homes. Lifestyle and diet related Motivational messaging carried out regularly. Patient will receive group session at the clinic every quarters. Control arm will receive their usual care provided by IHS. The control group will receive a health evaluation at the initiation of the study and at the 6-month and 12-month. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Patient Activation Measure (PAM) -13 Item Questionnaire | Patient Activation Measure (PAM) questionnaire gives total score of activation as well as levels (stages) of patient activation. PAM total score can range form 0-100 with higher score reflecting higher level of activation in Patient health care. PAM levels (Stages) 1 through 4 with 1 being the lowest activation and 4 being the highest activation level. We collected data about Changes in PAM score as well as levels (stages) from baseline to 12 months of intervention and compare it to Usual care group. | Posted | Mean | Standard Deviation | points | 12 months follow-up minus baseline values |
|
No adverse event data were collected over 12 month period of study intervention. There was no active monitoring for adverse events. However, upon completion of the study, our efforts to identify the reasons that led to study attrition, we found that a number of participants had passed away. None of the deaths were deemed to be a result of study participation.
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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 | Educational Intervention | Education and life style coaching includes: education about diabetes and kidney disease Coaching /counseling about lifestyle, nutrition and medication adherence |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death | General disorders | Non-systematic Assessment | The causes of deaths were not known to us. So for that reason we listed it as General disorder |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Other adverse event | General disorders | Non-systematic Assessment | We did not collect other adverse event |
The study took place in one Indian reservation in rural New Mexico. The results might be different for people in other places. The team didn't look at which parts of the program might explain the changes they found.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Vallabh Shah | University of New Mexico | 505-272-9615 | vshah@salud.unm.edu |
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| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D003920 | Diabetes Mellitus |
| D057240 | Patient Preference |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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|
| 12 months minus baseline values |
| Systolic Blood Pressure | Changes in Systolic blood pressure over study. | 12 months minus baseline values |
| Body Mass Index | Changes in the value of body mass index (BMI) | 12 months minus baseline values |
| Low-density Lipoprotein LDL Cholesterol | Changes in serum LDL cholesterol on study | 12 months minus baseline values |
| High-density Lipoprotein HDL Cholesterol | Change in serum HDL cholesterol on study | 12 months minus baseline values |
| Triglycerides | Change in serum triglycerides on study | 12 months minus baseline values |
| Serum Total Cholesterol | Change in total cholesterol on study | 12 months minus baseline values |
| High Sensitive C-reactive Protein-hsCRP | Changes in the serum c-reactive protein on study | 12 months minus baseline values |
| Serum Total Protein | Change in total protein on study | 12 months minus baseline values |
| eGFR | Changes in estimated (via CKD-EPI) Glomerular Filtration Rate. | 12 months minus baseline values |
| UACR | change in urinary albumin to creatinine ratio on study. | 12 months minus baseline values |
| KDQOL-Symptom/Problem | Changes on study of symptom/problem list from quality of life (KDQOL-36). Quality of life (QOL) was measured using the Kidney Disease Quality of Life-36 (KDQOL-36) survey, a kidney-disease-specific quality of life instrument that assesses five domains: general physical health (SF-12 Physical), mental health (SF-12 Mental), burden of kidney disease (BKD), disease symptoms problem list (SP), and effects of kidney disease (EKD). For all KDQOL scales, a higher score indicates better quality of life. All domain scales can range from 0-100. | 12 months minus baseline values |
| KDQOL-EKD | Changes in effects of kidney disease score from quality of life (KDQOL). Changes on study of effect of kidney disease from quality of life (KDQOL-36). Quality of life (QOL) was measured using the Kidney Disease Quality of Life-36 (KDQOL-36) survey, a kidney-disease-specific quality of life instrument that assesses five domains: general physical health (SF-12 Physical), mental health (SF-12 Mental), burden of kidney disease (BKD), disease symptoms problem list (SP), and effects of kidney disease (EKD). For all KDQOL scales, a higher score indicates better quality of life. All domain scales can range from 0-100. | 12 months minus baseline values |
| KDQOL-BKD | Change on study of burden of kidney disease score from KDQOL-36. Quality of life (QOL) was measured using the Kidney Disease Quality of Life-36 (KDQOL-36) survey, a kidney-disease-specific quality of life instrument that assesses five domains: general physical health (SF-12 Physical), mental health (SF-12 Mental), burden of kidney disease (BKD), disease symptoms problem list (SP), and effects of kidney disease (EKD). For all KDQOL scales, a higher score indicates better quality of life. All domain scales can range from 0-100. | 12 months minus baseline values |
| KDQOL-SF12 Physical Score | Changes on study of SF12 physical quality of life scale from the KDQOL-36. Quality of life (QOL) was measured using the Kidney Disease Quality of Life-36 (KDQOL-36) survey, a kidney-disease-specific quality of life instrument that assesses five domains: general physical health (SF-12 Physical), mental health (SF-12 Mental), burden of kidney disease (BKD), disease symptoms problem list (SP), and effects of kidney disease (EKD). For all KDQOL scales, a higher score indicates better quality of life. All domain scales can range from 0-100. | 12 months minus baseline values |
| KDQOL-SF12 Mental Score | Change on study of SF12 mental quality of life scale from the KDQOL-36 Quality of life (QOL) was measured using the Kidney Disease Quality of Life-36 (KDQOL-36) survey, a kidney-disease-specific quality of life instrument that assesses five domains: general physical health (SF-12 Physical), mental health (SF-12 Mental), burden of kidney disease (BKD), disease symptoms problem list (SP), and effects of kidney disease (EKD). For all KDQOL scales, a higher score indicates better quality of life. All domain scales can range from 0-100. | 12 months minus baseline values |
| 8-Item Morisky Score | Change in Morisky total score on study.The 8-item Morisky scale is a validated scale designed to estimate the risk of medication non-adherence. The Scale of the total score ranges from 0 to 8. We only report a total score. For a reported scale,
| 12 months minus baseline values |
| Newman S, Cheng T, Ghahate DM, Bobelu J, Sandy P, Faber T, Shah VO. Assessing knowledge and attitudes of diabetes in Zuni Indians using a culture-centered approach. PLoS One. 2014 Jun 11;9(6):e99614. doi: 10.1371/journal.pone.0099614. eCollection 2014. |
| 24528897 | Background | Shah VO, Ghahate DM, Bobelu J, Sandy P, Newman S, Helitzer DL, Faber T, Zager P. Identifying barriers to healthcare to reduce health disparity in Zuni Indians using focus group conducted by community health workers. Clin Transl Sci. 2014 Feb;7(1):6-11. doi: 10.1111/cts.12127. Epub 2013 Nov 8. |
| 20646805 | Background | MacCluer JW, Scavini M, Shah VO, Cole SA, Laston SL, Voruganti VS, Paine SS, Eaton AJ, Comuzzie AG, Tentori F, Pathak DR, Bobelu A, Bobelu J, Ghahate D, Waikaniwa M, Zager PG. Heritability of measures of kidney disease among Zuni Indians: the Zuni Kidney Project. Am J Kidney Dis. 2010 Aug;56(2):289-302. doi: 10.1053/j.ajkd.2010.03.012. Epub 2010 Jun 19. |
| 30442864 | Background | Nelson RG, Pankratz VS, Ghahate DM, Bobelu J, Faber T, Shah VO. Home-Based Kidney Care, Patient Activation, and Risk Factors for CKD Progression in Zuni Indians: A Randomized, Controlled Clinical Trial. Clin J Am Soc Nephrol. 2018 Dec 7;13(12):1801-1809. doi: 10.2215/CJN.06910618. Epub 2018 Nov 15. |
| 27197911 | Result | Cukor D, Cohen LM, Cope EL, Ghahramani N, Hedayati SS, Hynes DM, Shah VO, Tentori F, Unruh M, Bobelu J, Cohen S, Dember LM, Faber T, Fischer MJ, Gallardo R, Germain MJ, Ghahate D, Grote N, Hartwell L, Heagerty P, Kimmel PL, Kutner N, Lawson S, Marr L, Nelson RG, Porter AC, Sandy P, Struminger BB, Subramanian L, Weisbord S, Young B, Mehrotra R. Patient and Other Stakeholder Engagement in Patient-Centered Outcomes Research Institute Funded Studies of Patients with Kidney Diseases. Clin J Am Soc Nephrol. 2016 Sep 7;11(9):1703-1712. doi: 10.2215/CJN.09780915. Epub 2016 May 19. |
| BG001 | Usual Care (UC) Control Arm | once randomize to the Usual Care control group, the participants are left alone and are suggested to contact their providers for health care. The group gets labs and other survey done at 6 and 12 months of the intervention. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Patient Activation Measure - Total Score | PAM is 13 questionnaire use a categorical agreement scale with 4 response options: strongly disagree, disagree, agree, strongly agree, and N/A. The raw score is calculated by adding responses to the 13 questions. If all questions are answered, the range of raw scores is from 13 to 52. If there is at least 1 item with a response of N/A, the total score is divided by the number of items completed and multiplied by 13 to yield a normalized raw score. The score converts raw scores to an "activation score," ranging from 0 to 100 with a classification level between 1 and 4 | Mean | Standard Deviation | Score |
|
| Patient activation level >3 | Number of participants "activated" to be engaged in their own health care. | Number | participants with diabetes |
|
| Systolic Blood Pressure | Mean | Standard Deviation | mm Hg |
|
| Diastolic Blood Pressure | Mean | Standard Deviation | mm Hg |
|
| HbA1c | Glycosylated Hemoglobin | Mean | Standard Deviation | percentage |
|
| Hypertension | Count of Participants | Participants |
|
| Diabetes status | Count of Participants are with diabetes | Count of Participants | Participants |
|
| High School Graduate | Count of Participants | Participants |
|
| BMI | Body Mass Index | Mean | Standard Deviation | kg/m^2 |
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| Serum Total Protein | Mean | Standard Deviation | g/dl |
|
| Serum Cholesterol | Mean | Standard Deviation | mg/dl |
|
| Serum LDL Cholesterol | Mean | Standard Deviation | mg/dl |
|
| Serum HDL Cholesterol | Median | Inter-Quartile Range | mg/dl |
|
| Serum Triglycerides | Median | Inter-Quartile Range | mg/dl |
|
| eGFR | Estimated (via CKD-EPI) Glomerular Filtration Rate | Mean | Standard Deviation | mL/min/1.73 m^2 |
|
| UACR | Urine Albumin to Creatinine Ratio. | Median | Inter-Quartile Range | mg/g |
|
| hsCRP | High Sensitive c-Reactive Protein | Median | Inter-Quartile Range | mg/L |
|
| KDQOL-SP | Symptom/Problem List The KDQOL-36™ is a short form that includes the SF-12 as generic core plus the burden of kidney disease, symptoms/problems of kidney disease, and effects of kidney disease scales from the KDQOL-SF. Items 1-12: SF-12 Items 13-16: Burden of kidney disease (k=4) Items 17-28: Symptoms/problems (k=12) Items 29-36: Effects of kidney disease (k=8) | Mean | Standard Deviation | points |
|
| KDQOL-EKD | Effects on Kidney Disease. The KDQOL-36™ is a short form that includes the SF-12 as generic core plus the burden of kidney disease, symptoms/problems of kidney disease, and effects of kidney disease scales from the KDQOL-SF. Items 1-12: SF-12 Items 13-16: Burden of kidney disease (k=4) Items 17-28: Symptoms/problems (k=12) Items 29-36: Effects of kidney disease (k=8) | Mean | Standard Deviation | points |
|
| KDQOL-BKD | Burden of Kidney Disease. The KDQOL-36™ is a short form that includes the SF-12 as generic core plus the burden of kidney disease, symptoms/problems of kidney disease, and effects of kidney disease scales from the KDQOL-SF. Items 1-12: SF-12 Items 13-16: Burden of kidney disease (k=4) Items 17-28: Symptoms/problems (k=12) Items 29-36: Effects of kidney disease (k=8) | Mean | Standard Deviation | points |
|
| KDQOL-SF12 Physical Score | Physical Score (Quality of Life). The KDQOL-36™ is a short form that includes the SF-12 as generic core plus the burden of kidney disease, symptoms/problems of kidney disease, and effects of kidney disease scales from the KDQOL-SF. Items 1-12: SF-12 Items 13-16: Burden of kidney disease (k=4) Items 17-28: Symptoms/problems (k=12) Items 29-36: Effects of kidney disease (k=8) | Mean | Standard Deviation | points |
|
| KDQOL-SF12 Mental | Mental Quality of Life from Short Form-12 The KDQOL-36™ is a short form that includes the SF-12 as generic core plus the burden of kidney disease, symptoms/problems of kidney disease, and effects of kidney disease scales from the KDQOL-SF. Items 1-12: SF-12 Items 13-16: Burden of kidney disease (k=4) Items 17-28: Symptoms/problems (k=12) Items 29-36: Effects of kidney disease (k=8) | Mean | Standard Deviation | points |
|
| Morisky Score | 8-Item Morisky Medication Adherence Scale Morisky Medication Adherence Scale reflect that the reported values are from the 8-item version of the scale: zero remains the lowest level of medication adherence, but 8 is the highest level of medication adherence.
| Mean | Standard Deviation | Scores on a scale |
|
| OG001 | Usual Care (UC) Control Arm | once randomize to the Usual Care control group, the participants are left alone and are suggested to contact their providers for health care. The group gets labs and other survey done at 6 and 12 months of the intervention. |
|
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| Primary | Patient Activation Measure (PAM) Level Greater Than 2 | Participants in an "Activated" category. Patient Activation Measure (PAM) questionnaire gives total score of activation as well as levels (stages) of patient activation. PAM total score can range form 0-100 with higher score reflecting higher level of activation in Patient health care. PAM levels (Stages) 1 through 4 with 1 being the lowest activation and 4 being the highest activation level. Level 1 labeled as patient being dis-engaged, Level 2 labeled as patient becoming aware of health condition but still struggling, level 3 labeled as patient is taking action and gaining control of their health care and level 4 labeled as maintaining behaviors and pushing forward - for our analysis purposes we classified participants into levels 3 and 4 (activated) and level 1 and 2 as not activated. We collected data about Changes in PAM score as well as levels (stages) from baseline to 12 months of intervention and compare it to Usual care group. | Posted | Count of Participants | Participants | 12 months follow-up |
|
|
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| Secondary | A1c | Changes in clinical values | Posted | Mean | Standard Deviation | percentage | 12 months minus baseline values |
|
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| Secondary | Diastolic Blood Pressure | Changes in diastolic blood pressure on study. | Posted | Mean | Standard Deviation | mm Hg | 12 months minus baseline values |
|
|
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| Secondary | Systolic Blood Pressure | Changes in Systolic blood pressure over study. | Posted | Mean | Standard Deviation | mm Hg | 12 months minus baseline values |
|
|
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| Secondary | Body Mass Index | Changes in the value of body mass index (BMI) | Posted | Mean | Standard Deviation | kg/m^2 | 12 months minus baseline values |
|
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| Secondary | Low-density Lipoprotein LDL Cholesterol | Changes in serum LDL cholesterol on study | Posted | Mean | Standard Deviation | mg/dl | 12 months minus baseline values |
|
|
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| Secondary | High-density Lipoprotein HDL Cholesterol | Change in serum HDL cholesterol on study | Posted | Mean | Inter-Quartile Range | mg/dl | 12 months minus baseline values |
|
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| Secondary | Triglycerides | Change in serum triglycerides on study | Posted | Median | Inter-Quartile Range | mg/dl | 12 months minus baseline values |
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| Secondary | Serum Total Cholesterol | Change in total cholesterol on study | Posted | Mean | Standard Deviation | mg/dl | 12 months minus baseline values |
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| Secondary | High Sensitive C-reactive Protein-hsCRP | Changes in the serum c-reactive protein on study | Posted | Mean | Inter-Quartile Range | mg/L | 12 months minus baseline values |
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| Secondary | Serum Total Protein | Change in total protein on study | Posted | Mean | Standard Deviation | g/dl | 12 months minus baseline values |
|
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| Secondary | eGFR | Changes in estimated (via CKD-EPI) Glomerular Filtration Rate. | Posted | Mean | Standard Deviation | mL/min/1.73 m2 | 12 months minus baseline values |
|
|
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| Secondary | UACR | change in urinary albumin to creatinine ratio on study. | Posted | Median | Inter-Quartile Range | mg/g | 12 months minus baseline values |
|
|
|
| Secondary | KDQOL-Symptom/Problem | Changes on study of symptom/problem list from quality of life (KDQOL-36). Quality of life (QOL) was measured using the Kidney Disease Quality of Life-36 (KDQOL-36) survey, a kidney-disease-specific quality of life instrument that assesses five domains: general physical health (SF-12 Physical), mental health (SF-12 Mental), burden of kidney disease (BKD), disease symptoms problem list (SP), and effects of kidney disease (EKD). For all KDQOL scales, a higher score indicates better quality of life. All domain scales can range from 0-100. | Posted | Mean | Standard Deviation | points | 12 months minus baseline values |
|
|
|
| Secondary | KDQOL-EKD | Changes in effects of kidney disease score from quality of life (KDQOL). Changes on study of effect of kidney disease from quality of life (KDQOL-36). Quality of life (QOL) was measured using the Kidney Disease Quality of Life-36 (KDQOL-36) survey, a kidney-disease-specific quality of life instrument that assesses five domains: general physical health (SF-12 Physical), mental health (SF-12 Mental), burden of kidney disease (BKD), disease symptoms problem list (SP), and effects of kidney disease (EKD). For all KDQOL scales, a higher score indicates better quality of life. All domain scales can range from 0-100. | Posted | Mean | Standard Deviation | score on a scale | 12 months minus baseline values |
|
|
|
| Secondary | KDQOL-BKD | Change on study of burden of kidney disease score from KDQOL-36. Quality of life (QOL) was measured using the Kidney Disease Quality of Life-36 (KDQOL-36) survey, a kidney-disease-specific quality of life instrument that assesses five domains: general physical health (SF-12 Physical), mental health (SF-12 Mental), burden of kidney disease (BKD), disease symptoms problem list (SP), and effects of kidney disease (EKD). For all KDQOL scales, a higher score indicates better quality of life. All domain scales can range from 0-100. | Posted | Mean | Standard Deviation | score on a scale | 12 months minus baseline values |
|
|
|
| Secondary | KDQOL-SF12 Physical Score | Changes on study of SF12 physical quality of life scale from the KDQOL-36. Quality of life (QOL) was measured using the Kidney Disease Quality of Life-36 (KDQOL-36) survey, a kidney-disease-specific quality of life instrument that assesses five domains: general physical health (SF-12 Physical), mental health (SF-12 Mental), burden of kidney disease (BKD), disease symptoms problem list (SP), and effects of kidney disease (EKD). For all KDQOL scales, a higher score indicates better quality of life. All domain scales can range from 0-100. | Posted | Mean | Standard Deviation | score on a scale | 12 months minus baseline values |
|
|
|
| Secondary | KDQOL-SF12 Mental Score | Change on study of SF12 mental quality of life scale from the KDQOL-36 Quality of life (QOL) was measured using the Kidney Disease Quality of Life-36 (KDQOL-36) survey, a kidney-disease-specific quality of life instrument that assesses five domains: general physical health (SF-12 Physical), mental health (SF-12 Mental), burden of kidney disease (BKD), disease symptoms problem list (SP), and effects of kidney disease (EKD). For all KDQOL scales, a higher score indicates better quality of life. All domain scales can range from 0-100. | Posted | Mean | Standard Deviation | score on a scale | 12 months minus baseline values |
|
|
|
| Secondary | 8-Item Morisky Score | Change in Morisky total score on study.The 8-item Morisky scale is a validated scale designed to estimate the risk of medication non-adherence. The Scale of the total score ranges from 0 to 8. We only report a total score. For a reported scale,
| Posted | Mean | Standard Deviation | score on a scale | 12 months minus baseline values |
|
|
|
| 1 |
| 63 |
| 1 |
| 63 |
| 0 |
| 0 |
| EG001 | Usual Care - Control | once randomize to the Usual Care control group, the participants are left alone and are suggested to contact their providers for health care. The group gets labs and other survey done at 6 and 12 months of the intervention. | 3 | 62 | 3 | 62 | 0 | 0 |
|
|
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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 |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D017060 | Patient Satisfaction |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |