Home-Based Kidney Care, Patient Activation, and Risk Factors for CKD Progression in Zuni Indians: A Randomized, Controlled Clinical Trial

Abstract

Background and objectives: The burden of CKD is greater in ethnic and racial minorities and persons living in rural communities, where access to care is limited.

Design, setting, participants, & measurements: A 12-month clinical trial was performed in 98 rural adult Zuni Indians with CKD to examine the efficacy of a home-based kidney care program. Participants were randomized by household to receive usual care or home-based care. After initial lifestyle coaching, the intervention group received frequent additional reinforcement by community health representatives about adherence to medicines, diet and exercise, self-monitoring, and coping strategies for living with stress. The primary outcome was change in patient activation score, which assesses a participant's knowledge, skill, and confidence in managing his/her own health and health care.

Results: Of 125 randomized individuals (63 intervention and 62 usual care), 98 (78%; 50 intervention and 48 usual care) completed the 12-month study. The average patient activation score after 12 months was 8.7 (95% confidence interval, 1.9 to 15.5) points higher in the intervention group than in the usual care group after adjusting for baseline score using linear models with generalized estimating equations. Participants randomized to the intervention had 4.8 (95% confidence interval, 1.4 to 16.7) times the odds of having a final activation level of at least three ("taking action") than those in the usual care group. Body mass index declined by 1.1 kg/m² (P=0.01), hemoglobin A1c declined by 0.7% (P=0.01), high-sensitivity C-reactive protein declined by 3.3-fold (P<0.001), and the Short-Form 12 Health Survey mental score increased by five points (P=0.002) in the intervention group relative to usual care.

Conclusions: A home-based intervention improves participants' activation in their own health and health care, and it may reduce risk factors for CKD in a rural disadvantaged population.

Trial registration: ClinicalTrials.gov NCT02915029.

Keywords: Body Mass Index; C-Reactive Protein; Chronic Disease, kidney; Diet; Epidemiology and outcomes; Glycated Hemoglobin A; Life Style; Linear Models; Mentoring; Patient Participation; Public Health; Renal Insufficiency, Chronic; Vulnerable Populations; chronic kidney disease; clinical trial; outcomes; risk factors.

Graphical abstract

Figure 1.

The flow chart of the study population describes the enrollment, randomization, and follow-up of the study participants according to treatment assignment. All participants who completed the baseline and 12-month follow-up visit were included in the analysis.

Figure 2.

The patient activation score improved in those receiving home-based kidney care during the 12-month intervention but did not improve in those receiving standard care. The left panel shows absolute values at baseline and after 12 months of treatment. Participants will fall along the diagonal line if there is no change in patient activation score over time. The white circles represent the usual care group, and the black circles represent the intervention group. The right panel shows the change from baseline by treatment group. The white bars represent the usual care group, and the black bars represent the intervention group. PAM, patient activation measure.