Reducing Health Disparity in Chronic Kidney Disease in Zuni Indians
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of New Mexico
- Enrollment
- 125
- Primary Endpoint
- Patient Activation Measure (PAM) Level Greater Than 2
Study Overview
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.
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Factorial
- Primary Purpose
- Health Services Research
- Masking
- None
Eligibility Criteria
- Ages
- 21 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •Unwilling or unable to give informed consent.
Outcomes
Primary Outcomes
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.
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.
Secondary Outcomes
- Diastolic Blood Pressure(12 months minus baseline values)
- Body Mass Index(12 months minus baseline values)
- Serum Total Cholesterol(12 months minus baseline values)
- Systolic Blood Pressure(12 months minus baseline values)
- High-density Lipoprotein HDL Cholesterol(12 months minus baseline values)
- eGFR(12 months minus baseline values)
- Low-density Lipoprotein LDL Cholesterol(12 months minus baseline values)
- Triglycerides(12 months minus baseline values)
- Serum Total Protein(12 months minus baseline values)
- 8-Item Morisky Score(12 months minus baseline values)
- A1c(12 months minus baseline values)
- High Sensitive C-reactive Protein-hsCRP(12 months minus baseline values)
- UACR(12 months minus baseline values)
- KDQOL-Symptom/Problem(12 months minus baseline values)
- KDQOL-BKD(12 months minus baseline values)
- KDQOL-EKD(12 months minus baseline values)
- KDQOL-SF12 Physical Score(12 months minus baseline values)
- KDQOL-SF12 Mental Score(12 months minus baseline values)
Investigators
Vallabh O Shah
Professor
University of New Mexico