Recruiting
Phase 3

BP Management

Sponsor:

VA Office of Research and Development

Code:

NCT05546099

Conditions

Chronic Kidney Disease

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Self-management of BP medications

Self-monitoring of home BP

Study Details

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.

Conditions

Chronic Kidney Disease

Study ID

NCT05546099

Start date

Dec 15, 2022

Status verified date

Oct, 2025

Completion date

Nov 20, 2026

Anticipated

Primary completion date

Sep 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

160 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 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.

active comparator: Self-monitoring

Patients monitor their home BP and contact their 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.

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.

Primary outcome measure

  • Change in standardized office BP [ Time Frame: 12 months ]

Central Contacts and Locations

Central contacts

Diana Jalal, MD

(319) 338-0581diana.jalal@va.gov

Katharine M Geasland, RN

(319) 353-6318KATHARINE-GEASLAND@UIOWA.EDU

Locations

Iowa City VA Health Care System, Iowa City, IA

Recruiting

Iowa City, Iowa, United States, 52246-2292

Contacts

Diana Jalal, MD

319-338-0581diana.jalal@va.gov

John E Holman, MA MA

(319) 338-0581John.Holman2@va.gov

Principal Investigator:

Diana Jalal, MD

More Information

Sponsor

VA Office of Research and Development

Last update posted

Oct 30, 2025

Last verified

Oct, 2025

Keywords

  • kidney disease
  • hypertension
  • Home blood pressure
  • self-management

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by VA Office of Research and Development on 2025-10-30.