N/A
N=186
Home-Based Kidney Care in Native American's of New Mexico (HBKC)
Chronic Kidney Diseases
Bottom Line
View on ClinicalTrials.gov: NCT03179085 ↗Enrolled (actual)
186
Serious AEs
0.0%
Results posted
Apr 2025
Primary outcome: Primary: The Patient Activation Measure (PAM) — 60.8; 61.5; 1.73; 3.44 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Home-Based Kidney Care (Behavioral)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- University of New Mexico
- Primary completion
- Aug 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Patient Activation Measure (PAM) |
60.8; 61.5; 1.73; 3.44; 2.28; 3.59 | — |
| SECONDARY HbA1c |
8.65; 8.54; -0.31; -0.34; -0.23; -0.18 | — |
| SECONDARY Blood Glucose Levels |
172.06; 183.18; 24.06; -10.59; 28.62; 3.26 | — |
| SECONDARY HDL |
46.08; 46.38; 0.21; -0.61; -1.83; -1.59 | — |
| SECONDARY LDL |
73.66; 77.54; 12.59; -8.33; 4.18; 11.81 | — |
| SECONDARY Creatinine |
0.78; 0.80; 0.10; 0.14; 0.03; 0.21 | — |
| SECONDARY SF12 Physical |
43.50; 44.43; -2.07; -0.09; -1.18; -1.19 | — |
| SECONDARY SF12 Mental |
50.42; 51.33; 1.96; 0.47; 4.56; 2.53 | — |
Summary
People reach End Stage Renal Disease (ESRD) due to progressive chronic kidney disease (CKD). CKD is associated with increased risk for heart disease and death. The burden of chronic kidney disease is increased among minority populations compared to Caucasians. New Mexico American Indians are experiencing an epidemic of chronic kidney disease due primarily to the high rates of obesity and diabetes. The present study entitled Home-Based Kidney Care is designed to delay / reduce rates 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, the Albuquerque Area Indian Health Board and University of New Mexico faculty will decrease the risk for the development and the progression of CKD.
Eligibility Criteria
Inclusion Criteria
- (1) live in a household with 1 participant
- (2) age 21 to 80 years
- (3) negative pregnancy test in women of child-bearing potential
- (4) diagnosed diabetics or HbA1c >7
- (5) BMI >27 kg/m2 and UACR of >/= 30
Exclusion Criteria
- (1) life expectancy < 1 year
- (2) pregnancy or absence of reliable birth control in women of child-bearing potential
- (3) malignancy except non-melanoma skin cancer
- (4) blind
- (5) ESRD and on dialysis
- (6) kidney transplant recipient
- (7) unwilling or unable to give informed consent.
Data sourced from ClinicalTrials.gov (NCT03179085). 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.