A clinical trial evaluating pharmacist-guided self-management of hypertension among veterans with CKD, rationale and study design

Abstract

Rationale & objective

Chronic kidney disease (CKD) associates with high morbidity and mortality due to CKD progression and cardiovascular disease (CVD). Blood pressure (BP) lowering reduces the risk of CVD and CKD progression. Despite the large number of BP medications available, a significant proportion of patients with CKD have BP above the goal. The current practice involves licensed providers performing medication titrations to achieve BP goals and is associated with limited patient engagement. Here, we evaluate the effectiveness of pharmacist-guided patient-driven titration of BP medications in CKD.

Study design

Randomized clinical trial.

Setting & participants

One hundred and sixty Veterans with uncontrolled hypertension and either stage 2 CKD with albuminuria or stage 3 or 4 CKD are recruited from the Iowa City VA Healthcare system.

Interventions

Subjects are randomized to the pharmacist self-guided management arm or the self-monitoring arm for 12 months.

Outcomes

This is a mixed methods study. The primary outcome is change in standardized office systolic BP at 12 months. Secondary outcomes include change in standardized office diastolic BP, change in home systolic and diastolic BPs, change in conventional office systolic and diastolic BPs, and emergency room visits for uncontrolled hypertension or hypertensive emergency. The study team will conduct semi-structured interviews to evaluate the acceptability and the adherence to the self-management approach to Veterans and to assess potential barriers and facilitators to implementation of the self-management approach.

Trial Registration

NCT05546099