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Active, not recruitingNCT05546099Updated Oct 7, 2026

Patient-driven Management of BP in CKD

A Phase 3 interventional study of Self-management of BP medications and Self-monitoring of home BP in Chronic Kidney Disease, sponsored by VA Office of Research and Development. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-07.

Sponsored by VA Office of Research and Development · Phase 3, Interventional, and Treatment

Updated Oct 7, 2026Now Active, not recruitingEligibility revised+4 moreGo to Updates ↓
Phase
Phase 3
Study type
Interventional
Enrollment
160
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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).

02

Conditions studied

  • Chronic Kidney Disease

Keywords

  • kidney disease
  • hypertension
  • Home blood pressure
  • self-management
03

In context

Renal Insufficiency, Chronic

3,144 studies on the registry are indexed under Renal Insufficiency, Chronic; 704 are open to participants now.

This study's enrollment of 160 is above the median of 74 across 2,176 interventional studies indexed under Renal Insufficiency, Chronic.

Browse Renal Insufficiency, Chronic studies →

Lead sponsor

VA Office of Research and Development is the lead sponsor of 1,733 studies on the registry; 396 are open to participants now.

Of its 206 completed or terminated interventional studies of FDA-regulated products, 180 (87%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Chronic kidney disease stage 3 or 4 (estimated glomerular filtration rate: 15-59 milliliters per minute /1.73 square meters) or
  • Stage 2 chronic kidney disease (estimated GFR 60-89 milliliters per minute/1.73 square meters) with urinary albumin/creatinine ratio (ACR 300 milligrams per gram if no diabetes mellitus and 30 milligrams per gram if with diabetes mellitus), and
  • Uncontrolled hypertension defined as the avg of 2 readings > 140 systolic

Exclusion criteria

Exclusion Criteria:

  • Severely uncontrolled hypertension defined as systolic blood pressure (BP)>180
  • Patients with resistant hypertension and taking 4 blood pressure medications
  • Orthostatic hypotension defined as reduced systolic blood pressure by 20 millimeters of mercury or diastolic blood pressure by 10 millimeters of mercury after 3 minutes of standing
  • Severe chronic kidney disease defined as estimated glomerular filtration rate \< 20 milliliters per minute /1.73 square meters
  • 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
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
160 participants (actual)

Study 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.

    Behavioral: Self-management of BP medications

  • Active comparator
    Self-monitoring

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

    Behavioral: Self-monitoring of home BP

Interventions

  • BehavioralSelf-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.

  • BehavioralSelf-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.

06

What researchers measure

Primary outcomes

  1. Change in standardized office blood pressure (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.

    Time frame: 12 months

Secondary outcomes

  1. Change in conventional office blood pressure (BP)

    BP measured during standard of care clinical visits will be included.

    Time frame: 12 months

  2. Home blood pressure (BP) readings

    The average of the last 10 BP readings at home will be utilized a secondary outcome

    Time frame: 12 months

  3. Change in standardized office diastolic blood pressure (BP)

    Measured same as the primary outcome

    Time frame: 12 months

07

Study locations

1 site
  • Iowa City VA Health Care System, Iowa City, IA
    Iowa City, Iowa 52246-2292, United States
08

References and documents

Publications

  • 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. PubMed 40360073 ↗

Individual participant data

Plan to share: Yes — 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 the investigators share the data publicly, then and only then, would the investigators share that data via their requested path. However, no identifiable data, will be shared under any circumstance.

Supporting information: Study protocol, Sap

09

Updates

2 registry updates since Sep 25, 2026
Status
Recruiting→Active, not recruiting
changed Oct 2, 2026
Primary completion
Sep 30, 2026→Dec 15, 2026
Oct 2, 2026
Study completion
Nov 20, 2026→Sep 30, 2027
Oct 2, 2026
Also revised
eligibility and primary outcomes
Show all 2 updates
  1. Oct 7, 2026
    Eligibility Criteria revised
    + 2 other changes: verification date and design details
  2. Oct 2, 2026
    Recruiting→Active, not recruiting
    Primary completion Sep 30, 2026→Dec 15, 2026
    Study completion Nov 20, 2026→Sep 30, 2027
    Eligibility Criteria revised
    Primary outcomes Revised (2 changes)
    + 6 other changes: identifiers, verification date, secondary outcomes, contact details, site details and data sharing statement

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT05546099
Lead sponsor
VA Office of Research and Development
Responsible party
Sponsor
First posted
Sep 19, 2022
Start date
Dec 15, 2022
Primary completion
Dec 15, 2026 (estimated)
Completion
Sep 30, 2027 (estimated)
Last update
Oct 7, 2026

Study contacts

Diana Jalal, MD
principal investigator · Iowa City VA Health Care System, Iowa City, IA

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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