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NCT Number: NCT02915029

Home-base Kidney Care in Zuni Indians

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.

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Key information

Conditions

Chronic Kidney Disease Behavior Chronic Disease Diabetes Mellitus Disease Attributes Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Health Behavior Kidney Diseases Male Urogenital Diseases Metabolic Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Patient Preference Patient Satisfaction Renal Insufficiency Renal Insufficiency, Chronic Treatment Adherence and Compliance Urogenital Diseases Urologic Diseases

Age range

21 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of New Mexico

Other

Collaborators

  • Zuni Tribal Administration
  • Zuni comprehensive Community Health Center, Indian Health Services

Registry information

Official study title

Reducing Health Disparity in Chronic Kidney Disease in Zuni Indians

Acronym: HBKC

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Sep 26, 2016
Registry last updated
Dec 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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