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Home-base Kidney Care in Zuni Indians (HBKC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02915029
Recruitment Status : Completed
First Posted : September 26, 2016
Results First Posted : December 4, 2019
Last Update Posted : December 4, 2019
Sponsor:
Collaborators:
Zuni Tribal Administration
Zuni comprehensive Community Health Center, Indian Health Services
Information provided by (Responsible Party):
Vallabh O Shah, University of New Mexico

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Chronic Kidney Disease Other: Educational and lifestyle coaching Not Applicable

Detailed Description:

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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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 125 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Reducing Health Disparity in Chronic Kidney Disease in Zuni Indians
Study Start Date : October 2013
Actual Primary Completion Date : June 2016
Actual Study Completion Date : June 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

Arm Intervention/treatment
Experimental: Education and Lifestyle Coaching

Education and life style coaching includes:

education about diabetes and kidney disease Coaching /counseling about lifestyle, nutrition and medication adherence

Other: 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.


No Intervention: 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.



Primary Outcome Measures :
  1. Patient Activation Measure (PAM) -13 Item Questionnaire [ Time Frame: 12 months follow-up minus baseline values ]

    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.


  2. Patient Activation Measure (PAM) Level Greater Than 2 [ Time Frame: 12 months follow-up ]

    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.



Secondary Outcome Measures :
  1. A1c [ Time Frame: 12 months minus baseline values ]
    Changes in clinical values

  2. Diastolic Blood Pressure [ Time Frame: 12 months minus baseline values ]
    Changes in diastolic blood pressure on study.

  3. Systolic Blood Pressure [ Time Frame: 12 months minus baseline values ]
    Changes in Systolic blood pressure over study.

  4. Body Mass Index [ Time Frame: 12 months minus baseline values ]
    Changes in the value of body mass index (BMI)

  5. Low-density Lipoprotein LDL Cholesterol [ Time Frame: 12 months minus baseline values ]
    Changes in serum LDL cholesterol on study

  6. High-density Lipoprotein HDL Cholesterol [ Time Frame: 12 months minus baseline values ]
    Change in serum HDL cholesterol on study

  7. Triglycerides [ Time Frame: 12 months minus baseline values ]
    Change in serum triglycerides on study

  8. Serum Total Cholesterol [ Time Frame: 12 months minus baseline values ]
    Change in total cholesterol on study

  9. High Sensitive C-reactive Protein-hsCRP [ Time Frame: 12 months minus baseline values ]
    Changes in the serum c-reactive protein on study

  10. Serum Total Protein [ Time Frame: 12 months minus baseline values ]
    Change in total protein on study

  11. eGFR [ Time Frame: 12 months minus baseline values ]
    Changes in estimated (via CKD-EPI) Glomerular Filtration Rate.

  12. UACR [ Time Frame: 12 months minus baseline values ]
    change in urinary albumin to creatinine ratio on study.

  13. KDQOL-Symptom/Problem [ Time Frame: 12 months minus baseline values ]
    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.

  14. KDQOL-EKD [ Time Frame: 12 months minus baseline values ]
    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.

  15. KDQOL-BKD [ Time Frame: 12 months minus baseline values ]
    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.

  16. KDQOL-SF12 Physical Score [ Time Frame: 12 months minus baseline values ]
    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.

  17. KDQOL-SF12 Mental Score [ Time Frame: 12 months minus baseline values ]
    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.

  18. 8-Item Morisky Score [ Time Frame: 12 months minus baseline values ]

    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,

    • Zero reflects worse medication adherence and
    • 8 reflects better medication adherence We didn't combine the subscales to compute a total score, but the total score does reflect the number of individual items that were endorsed.



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Ages Eligible for Study:   21 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinical diagnosis of diabetes
  • Clinical diagnosis of microalbuminuria
  • Must be living in a household with more than 1 living participant
  • Age 21 to 80 years
  • Must have negative pregnancy test in women of child-bearing potential

Exclusion Criteria:

  • Life expectancy < 1 year
  • On dialysis
  • With renal transplant
  • Pregnancy or absence of reliable birth control in women of child-bearing potential
  • Malignancy except non-melanoma skin cancer
  • Blind
  • Unwilling or unable to give informed consent.
Publications of Results:
Other Publications:

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Responsible Party: Vallabh O Shah, Professor, University of New Mexico
ClinicalTrials.gov Identifier: NCT02915029    
Other Study ID Numbers: 10-249 -sub study HBKC
First Posted: September 26, 2016    Key Record Dates
Results First Posted: December 4, 2019
Last Update Posted: December 4, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Anonymized data will be available to share once the Zuni tribal leadership approves it.
Keywords provided by Vallabh O Shah, University of New Mexico:
Native American
Community Health Representative
Home base
Diabetes
Point of care testing
Patient Activation Measure
Patient preferences
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency