Self-Managed Blood Pressure Control for Chronic Kidney Disease

Recruiting in Palo Alto (17 mi)

Overseen by Diana Jalal, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Recruiting

Sponsor: VA Office of Research and Development

Disqualifiers: Severe hypertension, Severe CKD, others

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

Do I need to stop my current medications for the trial?

The trial information does not specify if you need to stop your current medications. However, since the study involves managing blood pressure medications, you may need to adjust your current medications under the guidance of a clinical pharmacist.

What data supports the effectiveness of the treatment Self-management of BP medications for Chronic Kidney Disease?

Research shows that home blood pressure monitoring helps people with chronic kidney disease better control their blood pressure, which can predict heart health and kidney function. Studies also indicate that self-measured blood pressure is more accurate than clinic measurements and can improve blood pressure control in patients on dialysis. ^{1 2 3 4 5}

Is self-managed blood pressure control safe for humans?

Research shows that self-monitoring and managing blood pressure at home is generally safe and can help people control their blood pressure better. This approach has been studied in various settings, including for people with high blood pressure and those on dialysis, without any major safety concerns reported. ^{1 2 6 7 8}

How is self-managed blood pressure control unique for chronic kidney disease?

Self-managed blood pressure control for chronic kidney disease is unique because it empowers patients to monitor and manage their blood pressure at home, which can lead to better blood pressure control and predict health outcomes. This approach differs from traditional treatments that rely on office visits and nurse-measured blood pressure, offering more frequent and personalized monitoring. ^{1 2 3 9 10}

Research Team

Diana Jalal, MD

Principal Investigator

Iowa City VA Health Care System, Iowa City, IA

Eligibility Criteria

This trial is for Veterans aged 18 or older with moderate chronic kidney disease (CKD) and uncontrolled high blood pressure. They must not be pregnant, have severe hypertension, liver disease, heart failure, cognitive decline due to dementia, or a life expectancy less than one year.

Inclusion Criteria

Your blood pressure is consistently higher than 140/90.

I am 18 years old or older.

My kidney function is reduced, and I may have protein in my urine.

Exclusion Criteria

You are expected to live less than 1 year.

Pregnant, breastfeeding, or unwilling to use adequate birth control

Your blood pressure drops significantly when you stand up after sitting or lying down for a few minutes.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized to either pharmacist-guided self-management or self-monitoring with standard care for blood pressure management

12 months

Regular visits as per protocol

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Self-management of BP medications (Behavioral Intervention)
• Self-monitoring of home BP (Behavioral Intervention)

Trial Overview The study compares two methods: patients managing their own blood pressure medication under a pharmacist's guidance versus standard care with home monitoring of blood pressure. It aims to see which method better lowers blood pressure in CKD patients.

Participant Groups

Group I: Self-management Experimental Treatment 1 Intervention

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.

Group II: Self-monitoring Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Dr. Grant Huang

VA Office of Research and Development

Acting Chief Research and Development Officer

PhD in Medical Psychology and Master of Public Health from the Uniformed Services University of Health Sciences

Dr. Erica M. Scavella

VA Office of Research and Development

Chief Medical Officer since 2022

MD from University of Massachusetts School of Medicine

Findings from Research

A nurse-managed, home-based hypertension management system significantly improved blood pressure control compared to standard care, with systolic BP reductions of 14.2 mm Hg in the intervention group versus 5.7 mm Hg in the control group after 6 months.

The intervention group also showed higher medication adherence (80.5% vs. 69.2%) and more frequent adjustments in drug therapy, indicating that structured support can enhance treatment effectiveness without causing adverse drug reactions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nurse management for hypertension. A systems approach. Rudd, P., Miller, NH., Kaufman, J., et al.[2022]

Home blood pressure monitoring can significantly aid in managing hypertension for patients with end-stage renal disease on hemodialysis, addressing the challenges of unreliable measurements at dialysis centers.

The study, supported by a grant from the American Nephrology Nurses' Association, utilized 35 home BP monitors, demonstrating their effectiveness in providing additional information for better blood pressure management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hypertension management in patients receiving hemodialysis: the benefits of home blood pressure monitoring. Lingerfelt, K., Hodnicki, D.[2012]

A new Home Blood Pressure Monitoring Adherence Scale was developed and tested on 436 patients with chronic kidney disease, demonstrating strong reliability with a Cronbach's α of 0.906 and good validity for assessing adherence to home blood pressure monitoring.

The scale consists of eight items and effectively measures adherence, making it a valuable tool for clinicians to improve blood pressure control in patients with chronic kidney disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development, Reliability, and Validity of the Home Blood Pressure Monitoring Adherence Scale for Patients with Chronic Kidney Disease. Wang, Y., Li, K., Li, H., et al.[2022]

In a study of 34 hemodialysis patients over 12 weeks, home blood pressure monitoring (HBPM) significantly reduced systolic blood pressure (SBP) compared to usual care, indicating its effectiveness in managing hypertension in this population.

No significant differences were observed in diastolic blood pressure (DBP) or fluid gains between the groups, suggesting that while HBPM helps with SBP control, it may not impact other related factors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving blood pressure control in hypertensive hemodialysis patients. Kauric-Klein, Z., Artinian, N.[2008]

Self-measured and ambulatory blood pressure (BP) monitoring provide a more accurate assessment of hypertension in chronic kidney disease (CKD) patients compared to clinic-obtained BP, which is crucial for effective management.

Out-of-office BP monitoring is recommended for all stages of CKD, as it better predicts target-organ damage and prognosis, and is particularly effective in diagnosing hypertension in hemodialysis patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Out-of-office blood pressure monitoring in chronic kidney disease. Agarwal, R., Peixoto, AJ., Santos, SF., et al.[2022]

Technology-based interventions, such as telemonitoring and education, can significantly enhance self-management of hypertension, as shown in a systematic review of 12 randomized controlled trials.

Combining interventions for both patients and physicians leads to better blood pressure control, suggesting that a collaborative approach is more effective in managing hypertension.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Self-management of hypertension using technology enabled interventions in primary care settings. Chandak, A., Joshi, A.[2022]

In a study involving 552 high-risk patients with hypertension, self-monitoring and self-titration of antihypertensive medication led to a significant reduction in systolic blood pressure by an average of 9.2 mm Hg compared to usual care after 12 months.

The self-management approach was effective across all patient subgroups and did not result in excessive adverse events, indicating it is a safe and beneficial strategy for managing blood pressure in patients with cardiovascular disease, diabetes, or chronic kidney disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of self-monitoring and medication self-titration on systolic blood pressure in hypertensive patients at high risk of cardiovascular disease: the TASMIN-SR randomized clinical trial. McManus, RJ., Mant, J., Haque, MS., et al.[2023]

In a 12-month trial involving 120 older adults (average age 79.5 years), combining home blood pressure telemonitoring with pharmacist-led case management did not significantly improve the achievement of target ambulatory blood pressure levels compared to usual care.

However, the intervention did lead to significant reductions in home blood pressure readings, although it also resulted in a higher incidence of hypotension (systolic BP < 110) without causing major adverse effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Telemonitoring and protocolized case management for hypertensive community dwelling older adults (TECHNOMED): a randomized controlled trial. Lau, D., Ringrose, J., McAlister, FA., et al.[2022]

In a study of 200 chronic kidney disease (CKD) patients, self-measured office blood pressure (SMOBP) and nurse-measured office blood pressure (NMOBP) showed no significant differences in average systolic and diastolic values, indicating that both methods are similarly effective for BP monitoring.

However, in about 25% of patients, there were notable discrepancies of 10 mmHg or more between SMOBP and NMOBP, particularly in patients over 60 years, suggesting that individual measurement circumstances can lead to significant variations in BP readings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of self- and nurse-measured office blood pressure in patients with chronic kidney disease. Tougaard, BG., Laursen, KS., Jensen, JD., et al.[2021]

A study involving 46 patients and 43 staff from kidney care clinics in British Columbia revealed significant gaps in knowledge and practices regarding home blood pressure monitoring (HBPM), highlighting the need for better education and implementation of best practices.

Patients and providers had differing perceptions of barriers to HBPM, with patients more likely to cite costs as a concern, while providers viewed anxiety as a barrier, indicating that tailored interventions could enhance HBPM adoption and improve blood pressure management in chronic kidney disease patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Patient-Provider Gap: A Cross-sectional Survey to Understand Barriers and Motivating Factors for Home Blood Pressure Monitoring in a CKD Cohort. Borkum, M., Levin, A., Williams, J., et al.[2023]

References

1. United States pubmed.ncbi.nlm.nih.gov

Nurse management for hypertension. A systems approach. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Hypertension management in patients receiving hemodialysis: the benefits of home blood pressure monitoring. [2012]

3. New Zealand pubmed.ncbi.nlm.nih.gov

Development, Reliability, and Validity of the Home Blood Pressure Monitoring Adherence Scale for Patients with Chronic Kidney Disease. [2022]

4. Canada pubmed.ncbi.nlm.nih.gov

Improving blood pressure control in hypertensive hemodialysis patients. [2008]

5. England pubmed.ncbi.nlm.nih.gov

Out-of-office blood pressure monitoring in chronic kidney disease. [2022]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Self-management of hypertension using technology enabled interventions in primary care settings. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Effect of self-monitoring and medication self-titration on systolic blood pressure in hypertensive patients at high risk of cardiovascular disease: the TASMIN-SR randomized clinical trial. [2023]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Telemonitoring and protocolized case management for hypertensive community dwelling older adults (TECHNOMED): a randomized controlled trial. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Comparison of self- and nurse-measured office blood pressure in patients with chronic kidney disease. [2021]

10. England pubmed.ncbi.nlm.nih.gov

The Patient-Provider Gap: A Cross-sectional Survey to Understand Barriers and Motivating Factors for Home Blood Pressure Monitoring in a CKD Cohort. [2023]