Patient-driven Management of BP in CKD
Pharmacist-guided, Patient-driven Management of High Blood Pressure in CKD: A Novel Approach
1 other identifier
interventional
160
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Dec 2022
Typical duration for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 14, 2022
CompletedFirst Posted
Study publicly available on registry
September 19, 2022
CompletedStudy Start
First participant enrolled
December 15, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 20, 2026
October 30, 2025
October 1, 2025
3.8 years
September 14, 2022
October 28, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in standardized office BP
Detailed procedure for standardized office BP measurement: This will be obtained by a trained research coordinator in accordance with the ACC/AHA and KDIGO (Kidney Disease Improving Global Outcomes) guideline.
12 months
Secondary Outcomes (3)
Change in conventional office BP
12 months
Home BP readings
12 months
Change in standardized office diastolic BP
12 months
Study Arms (2)
Self-management
EXPERIMENTALPatients monitor their home BP and self manage their BP medications based on a predesigned titration protocol and under the guidance of the clinical pharmacist.
Self-monitoring
ACTIVE COMPARATORPatients monitor their home BP and contact their provider if the BP is above the goal.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Iowa City VA Health Care System, Iowa City, IA
Iowa City, Iowa, 52246-2292, United States
Related Publications (1)
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.
PMID: 40360073DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Diana Jalal, MD
Iowa City VA Health Care System, Iowa City, IA
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 14, 2022
First Posted
September 19, 2022
Study Start
December 15, 2022
Primary Completion (Estimated)
September 30, 2026
Study Completion (Estimated)
November 20, 2026
Last Updated
October 30, 2025
Record last verified: 2025-10
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- This will be available after the study has concluded, anticipated November 2026 sometime.
- Access Criteria
- Only de-identified data will be shared via a LDS and only upon request and completion of DUA.
Only de- identified research data will be shared with the public. This will only be done under a data use agreement with the requesting entity. A Limited Dataset (LDS) will be created and shared pursuant to a Data Use Agreement (DUA) appropriately limiting use of the dataset and prohibiting the recipient from identifying or re-identifying (or taking steps to identify or re-identify) any individual whose data are included in the dataset. If a journal requires that we share the data publicly, then and only then, would we share that data via their requested path. However, no identifiable data, will be shared under any circumstance.