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Chronic Kidney DiseaseNCT05546099

Patient-driven Management of BP in CKD

A study testing Self-management of BP medications and Self-monitoring of home BP in people with Chronic Kidney Disease, run by VA Office of Research and Development at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chronic Kidney Disease
What is being tested?
Self-management of BP medications and Self-monitoring of home BP
Could I receive a placebo?
No, everyone receives an active treatment
How many people
160 participants
Where
1 siteUnited States
Study dates
15 Dec 2022to 30 Sep 2027
Phase
Interventional

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
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  • Severe congestive heart failure
  • Severe cognitive decline due to dementia
  • Pregnant, breastfeeding, or unwilling to use adequate birth control

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Iowa City VA Health Care System, Iowa City, IA

    Iowa City, Iowa, 52246-2292

Other trials in United States

About this study

Official title: Pharmacist-guided, Patient-driven Management of High Blood Pressure in CKD: A Novel Approach

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).

Being tested
Self-management of BP medications, Self-monitoring of home BP
Keywords
kidney disease, hypertension, Home blood pressure, self-management
Medical subject headings
Renal Insufficiency, Chronic, Kidney Diseases, Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Self-management of BP medicationsBehavioural

    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 BPBehavioural

    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.

Study groups in NCT05546099
Study groupRoleWhat they receive
Self-managementExperimentalPatients monitor their home BP and self manage their BP medications based on a predesigned titration protocol and under the guidance of the clinical pharmacist.
Receives: Behavioral: Self-management of BP medications
Self-monitoringActive comparatorPatients monitor their home BP and contact their provider if the BP is above the goal.
Receives: Behavioral: Self-monitoring of home BP

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 12 months

Secondary outcomes (3)
  1. Change in conventional office blood pressure (BP)

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

    Measured: 12 months

  2. Home blood pressure (BP) readings

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

    Measured: 12 months

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

    Measured same as the primary outcome

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Sep 2022
  2. Study start15 Dec 2022
  3. Primary completion15 Dec 2026 (estimated)
  4. Study completion30 Sep 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
The intervention is monitoring home BP and adjust meds based on a protocol and under the guidance of a clinical pharmacist.
Masking
None (open label)
Enrolment
160 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05546099
Sponsor's protocol ID
IIR 21-255
Other IDs
5I01HX003533-03
Status last verified
Oct 2026
First submitted
14 Sep 2022
Last updated
23 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
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.

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

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