N/A
N=125
Home-base Kidney Care in Zuni Indians
Chronic Kidney Disease
Bottom Line
View on ClinicalTrials.gov: NCT02915029 ↗Enrolled (actual)
125
Serious AEs
3.2%
Results posted
Dec 2019
Primary outcome: Primary: Patient Activation Measure (PAM) -13 Item Questionnaire — 9.1; -1.4 points — p=0.01
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Educational and lifestyle coaching (Other)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- University of New Mexico
- Primary completion
- Jun 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Patient Activation Measure (PAM) -13 Item Questionnaire |
9.1; -1.4 | 0.01 sig |
| PRIMARY Patient Activation Measure (PAM) Level Greater Than 2 |
44; 33 | — |
| SECONDARY A1c |
-0.5; 0.1 | — |
| SECONDARY Diastolic Blood Pressure |
-0.1; 0.2 | — |
| SECONDARY Systolic Blood Pressure |
3.4; 5.2 | — |
| SECONDARY Body Mass Index |
-1.3; -0.2 | — |
| SECONDARY Low-density Lipoprotein LDL Cholesterol |
-12.4; -4.9 | — |
| SECONDARY High-density Lipoprotein HDL Cholesterol |
3.5; 1.5 | — |
| SECONDARY Triglycerides |
-8.0; -8.5 | — |
| SECONDARY Serum Total Cholesterol |
-19; -4.5 | — |
| SECONDARY High Sensitive C-reactive Protein-hsCRP |
-1.5; 1.7 | — |
| SECONDARY Serum Total Protein |
-0.2; -0.1 | — |
| SECONDARY eGFR |
-5.2; -9.6 | — |
| SECONDARY UACR |
-45; 17.5 | — |
| SECONDARY KDQOL-Symptom/Problem |
0.1; 2.7 | — |
| SECONDARY KDQOL-EKD |
3.2; 2.9 | — |
| SECONDARY KDQOL-BKD |
14.8; 2.3 | — |
| SECONDARY KDQOL-SF12 Physical Score |
2.1; 0.8 | — |
| SECONDARY KDQOL-SF12 Mental Score |
7.5; -0.2 | — |
| SECONDARY 8-Item Morisky Score |
5.4; 4.6 | — |
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.
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT02915029). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.