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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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
- Are there results?
- Not yet: the study is under way
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
Show all 9Show fewer
- 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
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).
- Conditions
- Chronic Kidney Disease
- 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 group | Role | What they receive |
|---|---|---|
| Self-management | Experimental | 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. Receives: Behavioral: Self-management of BP medications |
| Self-monitoring | Active comparator | Patients 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.
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)
Change in conventional office blood pressure (BP)
BP measured during standard of care clinical visits will be included.
Measured: 12 months
Home blood pressure (BP) readings
The average of the last 10 BP readings at home will be utilized a secondary outcome
Measured: 12 months
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.
- First posted19 Sep 2022
- Study start15 Dec 2022
- Primary completion15 Dec 2026 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Diana Jalal, MD, Principal investigator, Iowa City VA Health Care System, Iowa City, IA
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
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacist-guided, Patient-driven Management of High Blood Pressure in CKD: A Novel Approach
- ClinicalTrials.gov ID
- NCT05546099
- Acronym / sponsor ID
- IIR 21-255
- Conditions
- Chronic Kidney Disease
- Keywords
- kidney disease, hypertension, Home blood pressure, self-management
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 160 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 15 Dec 2022 (actual)
- Primary completion
- 15 Dec 2026 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 19 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The intervention is monitoring home BP and adjust meds based on a protocol and under the guidance of a clinical pharmacist.
| Arm | Type | Receives |
|---|---|---|
| Self-management | Experimental | Behavioral: Self-management of BP medicationsPatients 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 comparator | Behavioral: Self-monitoring of home BPPatients monitor their home BP and contact their provider if the BP is above the goal. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Self-management of BP medicationsPatients 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. | Behavioural | Self-management |
| Self-monitoring of home BPPatients 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. | Behavioural | Self-monitoring |
Primary outcome
Change in standardized office blood pressure (BP)
Time frame: 12 months
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.
3 secondary outcomes
Change in conventional office blood pressure (BP)
Time frame: 12 months
Home blood pressure (BP) readings
Time frame: 12 months
Change in standardized office diastolic blood pressure (BP)
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2026.
- Derived from this study: PubMed 40360073Good 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.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Diana Jalal, MD principal investigator
Iowa City VA Health Care System, Iowa City, IA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 23 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in standardized office blood pressure (BP) (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05546099, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2026.