Patient-driven Management of BP in CKD

NCT ID: NCT05546099

Last Updated: 2025-10-30

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 160 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-15
• Study Completion Date: 2026-11-20

Brief Summary

The proposed research will evaluate if patients managing their blood pressure medications under the guidance of a clinical pharmacist works better to lower blood pressure than patients monitoring their blood pressure at home and the standard care. 60 Veterans with chronic kidney disease (CKD) will be included in the study. The study will further evaluate factors that may influence the Veteran to accept the self-management approach and what factors in the VHA healthcare system affect the implementation of the self-management approach.

Detailed Description

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. In spite of the large number of BP medications available, a significant proportion of Veterans 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. The investigators preliminary data indicate that the implementation of pharmacist-guided patient-driven titration of BP medications is effective and feasible in CKD. In this model, Veterans self-manage their BP medications under the guidance of the clinical pharmacist based on a pre-determined medication titration plan.

The prevalence of CKD is extremely high among Veterans, with some studies reporting a prevalence of 47% (vs 11% in the general population). Here, the investigators propose a novel interdisciplinary care model that engages the Veterans as an active participant in their care with the goal of improving BP control to improve long term outcomes. The application addresses a key HSR&D priority (management of complex chronic disease).

The proposed care model is one that has not been tested and includes the clinical pharmacist working with the provider and the Veterans so that Veterans with CKD can self-manage their hypertension. While self-management is exercised in CKD once patients are on dialysis (via home dialysis modalities), the self-management approach is not utilized in the earlier stages of CKD. Importantly, in the approach, the investigators will utilize a transdisciplinary approach to evaluate the implementation of pharmacist-guided self-management of BP medications and the investigators will apply constructs of an implementation science framework, Consolidated Framework for Implementation Research (CFIR), to understand Veteran and system factors that may either facilitate or impede the implementation and sustainment of the pharmacist-guided self-management approach.

Specific aim 1 will evaluate if pharmacist-guided self-management of BP medications is more effective than self-monitoring of home BP + the standard care amongst Veterans with CKD. Specific aim 2 will identify and understand Veteran factors that may influence the acceptability of and the adherence to the self-management approach whereas specific aim 3 will focus on understanding system factors that may facilitate or impede the implementation of the self-management approach.

One hundred and sixty Veterans with uncontrolled hypertension and either stage 2 CKD with albuminuria or stage 3 and 4 CKD will be randomized to either pharmacist-guided self-management or to self-monitoring + the standard practice for 12 months. Aim 1 will evaluate change in [standardized] office systolic BP at 12 months as the primary outcome. Aim 2 will utilize a mixed methods approach including semi-structured interviews to evaluate a sample of 20 Veterans in each of the study arms. The investigators will further design data abstraction tools to evaluate the adherence to the intervention. In aim 3, the investigators will utilize CFIR constructs to guide the investigators qualitative semi-structured interviews with key organizational stakeholders including PACT clinical pharmacists, PCPs, and CKD providers (20 key stakeholders).

The PI will implement the pharmacist-guided self-management approach with the Pharmacy and Ambulatory care services as operational partners. The implementation of this approach will improve the patient experience (Survey of Healthcare Experiences of Patients) and the quality of care (Clinical Performance Measurement Program and the Strategic Analytics for Improvement and Learning).

Conditions

Chronic Kidney Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Self-management

Patients monitor their home BP and self manage their BP medications based on a predesigned titration protocol and under the guidance of the clinical pharmacist.

Group Type: EXPERIMENTAL

Self-management of BP medications

Intervention Type: BEHAVIORAL

Patients will be educated on how to manage their home BP based on a pre-determined protocol. They will then monitor home BP and adjust meds accordingly and under the guidance of the clinical pharmacist.

Self-monitoring

Patients monitor their home BP and contact their provider if the BP is above the goal.

Group Type: ACTIVE_COMPARATOR

Self-monitoring of home BP

Intervention Type: BEHAVIORAL

Patients will be educated on how to monitor home BP and will be educated to contact their primary care provider/CKD provider if the BP is above the goal.

Interventions

Self-management of BP medications

Patients will be educated on how to manage their home BP based on a pre-determined protocol. They will then monitor home BP and adjust meds accordingly and under the guidance of the clinical pharmacist.

Intervention Type: BEHAVIORAL

Self-monitoring of home BP

Patients will be educated on how to monitor home BP and will be educated to contact their primary care provider/CKD provider if the BP is above the goal.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Age >= 18 years,
• CKD stage 3 or 4 (estimated GFR: 15-59 mL/min/1.73m2) or
• Stage 2 CKD (estimated GFR 60-89 mL/min/1.73m2) with urinary albumin/creatinine ratio (ACR 300 mg/g if no DM and 30 mg/g if with DM), and
• Uncontrolled hypertension defined as the avg of 2 readings > 140 systolic.

Exclusion Criteria

• Severely uncontrolled hypertension defined as systolic BP >180,
• Patients with resistant hypertension and taking 4 BP medications,
• Orthostatic hypotension defined as reduced systolic BP by 20 mmHg or diastolic BP by 10 mmHg after 3 minutes of standing,
• Severe CKD defined as estimated GFR < 20 mL/min/1.73m2,
• Life expectancy <1 year,
• Severe liver disease,
• Severe congestive heart failure,
• Severe cognitive decline due to dementia,
• Pregnant, breastfeeding, or unwilling to use adequate birth control

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

VA Office of Research and Development

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Diana Jalal, MD

Role: PRINCIPAL_INVESTIGATOR

Iowa City VA Health Care System, Iowa City, IA

Locations

Iowa City VA Health Care System, Iowa City, IA

Iowa City, Iowa, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Diana Jalal, MD

Role: CONTACT

diana.jalal@va.gov

(319) 338-0581 ext. 635214

Katharine M Geasland, RN

Role: CONTACT

KATHARINE-GEASLAND@UIOWA.EDU

(319) 353-6318

Facility Contacts

Diana Jalal, MD

Role: primary

diana.jalal@va.gov

319-338-0581 ext. 635214

John E Holman, MA MA

Role: backup

John.Holman2@va.gov

(319) 338-0581 ext. 7507

References

Good M, Hoskins R, Lund BC, Ten Eyck P, Dixon B, Cohen J, Reisinger Schact H, Kennelty K, Jalal D. A clinical trial evaluating pharmacist-guided self-management of hypertension among veterans with CKD, rationale and study design. Contemp Clin Trials. 2025 Jul;154:107950. doi: 10.1016/j.cct.2025.107950. Epub 2025 May 11.

Reference Type: DERIVED

PMID: 40360073 (View on PubMed)

Other Identifiers

IIR 21-255

Identifier Type: -

Identifier Source: org_study_id