Telemonitoring for Hypertension in Chronic Kidney Disease

Recruiting in Palo Alto (17 mi)

Overseen by Aminu Bello, MD PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of Alberta

Must be taking: Antihypertensives

Disqualifiers: Stage 5 CKD, Heart failure, Terminal illness, others

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

Background: Hypertension, together with poorly controlled blood pressure (BP) are known risk factors for kidney disease and progression to kidney failure as well as increased cardiovascular (CV) morbidity and mortality. Several studies in patients without kidney disease have demonstrated the efficacy of home BP telemonitoring (HBPT) for BP control. Objective: The primary aim of this study is to assess the mean difference in systolic BP (SBP) at 12 months, from baseline in remote dwelling patients with hypertension and chronic kidney disease (CKD) in Northern Alberta, Canada, comparing HBPT + usual care versus HBPT + a case manager. Other secondary objectives, including cost-effectiveness and acceptability of HBPT as well as occurrence of adverse events will also be assessed. Methods Design: This study is designed as a pragmatic randomized controlled trial (RCT) of HBPT plus clinical case management compared to HBPT with usual care. Setting: Peace River region in Northern Alberta Region, Canada. Patients: Primary care patients with CKD and hypertension. Measurements: Eligible patients will be randomized 1:1 to HBPT + BP case management versus HBPT + usual care. In the intervention arm, BP will be measured 4 times daily for 1 week, with medications titrated up or down by the study case manager until guideline targets (systolic BP \[SBP\]: \<130mmHg) are achieved. Once BP is controlled, (i.e., to guideline-concordant targets), this 1-week protocol will be repeated every 3 months for 1 year. Patients in the control arm will also follow the same BP measurement protocol, however, there will be no interactions with the case manager; they will share their BP readings with their primary care physicians or nurse practitioners at scheduled visits. Limitations: Potential limitations of this study include the relatively short duration of follow-up, possible technological pitfalls, and need for patients to own a smartphone and have access to the internet to participate. Conclusions: As this study will focus on a high-risk population that has been characterized by a large care gap, it will generate important evidence that would allow targeted and effective population-level strategies to be implemented to improve health outcomes for high-risk hypertensive CKD patients in Canada's remote communities.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop your current medications. However, it mentions that medications may be adjusted by the study case manager to meet blood pressure targets.

What data supports the effectiveness of the treatment Home BP Telemonitoring System for hypertension in chronic kidney disease?

Research shows that home blood pressure telemonitoring (HBPT) helps improve blood pressure control and speeds up care decisions, which can reduce negative outcomes related to high blood pressure in patients with chronic kidney disease.

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Is home blood pressure telemonitoring safe for humans?

Research on home blood pressure telemonitoring (HBPT) shows it is generally safe, with studies focusing on its effectiveness and impact on blood pressure control, healthcare use, and quality of life, without highlighting significant safety concerns.

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How is the Home BP Telemonitoring System treatment different from other treatments for hypertension in chronic kidney disease?

The Home BP Telemonitoring System is unique because it allows patients to monitor their blood pressure at home and automatically sends the data to healthcare providers, which can lead to faster and more accurate treatment decisions compared to traditional in-office blood pressure measurements.

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Eligibility Criteria

This trial is for adults over 18 with chronic kidney disease and hypertension living in the Peace River region of Alberta, Canada. Participants must own a smartphone with internet, speak English, be willing to use a home BP telemonitoring system regularly, and not have terminal illness or severe heart failure.

Inclusion Criteria

Owning a smartphone (iOS or Android) with access to wireless internet connection

Proficiency in English language (both verbal and written); and ability and willingness to provide informed consent for participation

Ability and willingness to use the HBPT device (≥ 80% recordings sent in the training period)

Exclusion Criteria

Presence of any terminal illness (life expectancy < 1 year)

Participation in any ongoing clinical drug trial

Pregnancy, lactation / breastfeeding

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Collection of demographic and health behavior information, baseline laboratory measurements, and BP measurement training

1 week

1 visit (in-person or virtual)

Treatment

Participants receive home-based BP telemonitoring with or without case management, with BP measured 4 times daily for 1 week, repeated every 3 months for 1 year

12 months

Monthly virtual check-ins

Follow-up

Participants are monitored for safety and effectiveness after treatment, including final BP measurements and assessment of secondary outcomes

4 weeks

1 visit (in-person or virtual)

Participant Groups

The study tests if adding case management to home blood pressure monitoring helps control blood pressure better than monitoring alone in hypertensive patients with chronic kidney disease. It's a randomized trial where half get extra support from a case manager.

Group I: home-based BP telemonitoring Active Control 1 Intervention

Patients will receive a Bluetooth-enabled and validated electronic upper arm oscillometric BP device (A\&D Ltd. UA-651BLE; San Jose, CA) that will be paired to their smartphone. Patients will be required to sit with their back rested for at least 5 minutes with the BP cuff around their arm. They will then be required to push the start button on the HBPT device to initiate BP measurement. HBPT values will be based on a series comprised of the mean of duplicate measures, for morning and evening, for a 7-day period and the first day home BP values will not be considered. The BP data will be auto transmitted via Bluetooth to their smartphone and relayed to a secure web portal for review.

Group II: usual care Placebo Group 1 Intervention

Patients in the control arm will also follow the same BP measurement protocol as the 'active comparator (intervention) group, however, there will be no interactions with the case manager; they will share their BP readings with their primary care physicians or nurse practitioners at scheduled visits.

Home BP Telemonitoring System is already approved in Canada, United States, European Union for the following indications:

🇨🇦 Approved in Canada as Home BP Telemonitoring System for:

• Hypertension management in patients with chronic kidney disease

🇺🇸 Approved in United States as Home Blood Pressure Monitoring for:

• Hypertension management
• Chronic kidney disease management

🇪🇺 Approved in European Union as Telemonitoring System for:

• Hypertension management
• Cardiovascular disease prevention

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

University of Alberta Edmonton, Canada

Who Is Running the Clinical Trial?

University of Alberta Lead Sponsor

References

1. England pubmed.ncbi.nlm.nih.gov

Impact of home telemonitoring and management support on blood pressure control in non-dialysis CKD: a systematic review protocol. [2022] Hypertension is a common public health problem and a key modifiable risk factor for cardiovascular (CV) and chronic kidney disease (CKD). Home blood pressure (BP) telemonitoring (HBPT) and management is associated with improved BP control, accelerated delivery of care and decision-making strategies that can reduce adverse outcomes associated with hypertension. The aim of this paper is to describe the protocol for a systematic review to assess the impact of HBPT interventions used for improving BP control and reducing CV and kidney outcomes in non-dialysis CKD patients.

2. England pubmed.ncbi.nlm.nih.gov

Telemonitoring and Case Management for Hypertensive and Remote-Dwelling Patients With Chronic Kidney Disease-The Telemonitoring for Improved Kidney Outcomes Study (TIKO): A Clinical Research Protocol. [2022] Hypertension, together with poorly controlled blood pressure (BP) are known risk factors for kidney disease and progression to kidney failure as well as increased cardiovascular (CV) morbidity and mortality. Several studies in patients without kidney disease have demonstrated the efficacy of home BP telemonitoring (HBPT) for BP control.

3. England pubmed.ncbi.nlm.nih.gov

Impact of Home Telemonitoring and Management Support on Blood Pressure Control in Nondialysis CKD: A Systematic Review and Meta-Analysis. [2022] Hypertension is a major cause of cardiovascular disease, chronic kidney disease (CKD), and death. Several studies have demonstrated the efficacy of home blood pressure telemonitoring (HBPT) for blood pressure (BP) control and outcomes, but the effects of this intervention remain unclear in patients with CKD.

4. 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] Home blood pressure monitoring helps patients with chronic kidney disease to improve blood pressure control and can predict cardiovascular events, renal function progress, and risk of death. Few instruments are available to assess patient adherence to home blood pressure monitoring.

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

Hypertension management in patients receiving hemodialysis: the benefits of home blood pressure monitoring. [2012] Patients with end stage renal disease on hemodialysis are at risk for cardiovascular events and increased mortality. Hypertension contributes to these risks and can be difficult to assess due to unreliable blood pressure (BP) measurements at dialysis centers. A clinical practice grant from the American Nephrology Nurses'Association allowed for the purchase of 35 home BP monitors to study the use of these monitors to provide additional information for BP management. Findings indicated that home BP monitoring can be an effective tool in hypertension management.

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

Clinical usefulness and cost effectiveness of home blood pressure telemonitoring: meta-analysis of randomized controlled studies. [2023] To systematically review data from randomized controlled studies on the effectiveness of home blood pressure telemonitoring (HBPT) versus usual care with respect to improvement of BP control, healthcare resources utilization and costs, patient's quality of life and adverse events.

7. Canada pubmed.ncbi.nlm.nih.gov

Differentiated Effects and Determinants of Home Blood Pressure Telemonitoring: Three-Year Cohort Study in Jieshou, Anhui, China. [2022] Home blood pressure telemonitoring (HBPT) is witnessing rapid diffusion worldwide. Contemporary studies documented mainly short-term (6-12 months) effects of HBPT, and there are limited data about its uptake.

8. England pubmed.ncbi.nlm.nih.gov

Automatic transmission of home blood pressure data can be effective in managing hypertension: a systematic review and meta-analysis. [2023] Home blood pressure telemonitoring (HBPT) is a useful way to manage BP. Recent advances in digital technology to automatically transmit BP data without the patient input may change the approach to long-term BP treatment and follow-up. The purpose of this review is to summarize the latest data on the HBPT with automatic data transmission.

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

Home blood pressure monitoring in CKD. [2014] Hypertension is common in patients with chronic kidney disease (CKD) and the prevalence increases with declining kidney function. Hypertension management is particularly important due to the increased risk of cardiovascular disease and stroke in the CKD population. Most clinical decisions for blood pressure (BP) management are based on BP readings in the office or dialysis unit. These BP readings often are inaccurate. Home BP monitoring provides more data than conventional clinic or dialysis-unit BP measurements and is relatively easy to accomplish, is cost-effective, and has been shown to have an increasing role in the management of BP in the CKD population. This In Practice article focuses on the use of home BP monitoring in patients with CKD. We also provide guidance for choosing a BP monitoring device and review recent literature regarding the use of home BP monitoring and the effect on CKD outcomes. In addition, we address the future use of electronic medical records and how they may interface with home BP monitoring.