Telemonitoring for Hypertension in Chronic Kidney Disease

Overseen By Deenaz Zaidi

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Alberta

Must be taking: Antihypertensives

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: 12 months

146 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to find the best way to manage high blood pressure in people with chronic kidney disease (CKD) through at-home monitoring. Participants will use a device at home to check their blood pressure, with some receiving additional support from a case manager. The study will compare whether this added support is more effective than using the device alone. Eligible participants have CKD and high blood pressure, live in Northern Alberta, and own a smartphone with internet access. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance at-home care for CKD patients.

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 prior data suggests that this telemonitoring system is safe for patients with hypertension and chronic kidney disease?

Research has shown that checking blood pressure at home using telemonitoring is safe for people with long-term health issues, including chronic kidney disease (CKD). A recent study found that this method improved blood pressure and kidney health in these patients. Another study demonstrated that this approach is practical and effective. No major safety issues emerged in these studies, suggesting that home blood pressure telemonitoring is generally well-tolerated and could be a good option for managing high blood pressure in people with CKD. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the home BP telemonitoring system for hypertension in chronic kidney disease because it offers a new way to manage blood pressure remotely and efficiently. Unlike traditional treatments that require regular in-person visits for monitoring, this system uses a Bluetooth-enabled device that automatically sends blood pressure data from the patient's home directly to healthcare providers. This technology allows for more consistent monitoring and timely adjustments to treatment, potentially improving blood pressure control and reducing complications associated with chronic kidney disease.

What evidence suggests that home BP telemonitoring is effective for hypertension in chronic kidney disease?

Research has shown that checking blood pressure at home using telemonitoring can help lower blood pressure in people with chronic kidney disease (CKD). A review of studies found that this method slightly reduces blood pressure and somewhat improves kidney function. In this trial, participants in the home-based BP telemonitoring arm will use a Bluetooth-enabled device to monitor their blood pressure at home. Another study showed that home monitoring, combined with support from healthcare providers, helped control blood pressure in high-risk CKD patients. Additionally, when home monitoring was paired with help from a pharmacist, it lowered blood pressure more effectively than standard care for the first 18 months, although this effect did not last over time. Overall, home blood pressure telemonitoring seems to be a promising way to manage high blood pressure in CKD patients. ^{1 2 3 6 7}

Who Is on the Research Team?

Aminu Bello, MD PhD

Principal Investigator

University of Alberta

Are You a Good Fit for This Trial?

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

Timeline for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

Interventions

• Home BP Telemonitoring System

Trial Overview 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.

How Is the Trial Designed?

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

Who Is Running the Clinical Trial?

University of Alberta

Lead Sponsor

Trials

957

Recruited

437,000+

Published Research Related to This Trial

This study aims to evaluate the effectiveness of home blood pressure telemonitoring (HBPT) combined with case management versus usual care in managing systolic blood pressure in patients with hypertension and chronic kidney disease over 12 months.

By involving a case manager to adjust medications based on daily BP readings, the study seeks to achieve guideline targets for blood pressure (<130 mmHg), potentially improving health outcomes for high-risk patients in remote areas of Northern Alberta.

NCBI (Pubmed)

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. Okpechi, IG., Zaidi, D., Ye, F., et al.[2022]

This systematic review aims to evaluate the effectiveness of home blood pressure telemonitoring (HBPT) in improving blood pressure control and reducing cardiovascular and kidney disease outcomes in non-dialysis chronic kidney disease (CKD) patients, based on a comprehensive search of multiple databases for relevant studies.

The review will include studies published up to 2020, ensuring a broad analysis of existing data, which will help inform healthcare strategies for managing hypertension in CKD patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of home telemonitoring and management support on blood pressure control in non-dialysis CKD: a systematic review protocol. Okpechi, IG., Muneer, S., Tinwala, MM., et al.[2022]

Home blood pressure telemonitoring (HBPT) significantly lowers systolic blood pressure (SBP) by an average of 8.8 mm Hg and diastolic blood pressure (DBP) by 2.4 mm Hg in patients with chronic kidney disease (CKD), based on a systematic review of 7 studies involving various populations.

In addition to lowering blood pressure, HBPT is associated with a significant improvement in kidney function, as indicated by an increase in estimated glomerular filtration rate (eGFR) by 5.4 mL/min/1.73 m², suggesting potential benefits for cardiovascular and kidney health in CKD patients.

NCBI (Pubmed)

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. Muneer, S., Okpechi, IG., Ye, F., et al.[2022]

Home blood pressure telemonitoring (HBPT) showed significant effects on systolic and diastolic blood pressure over a 3-year period, with changes in systolic blood pressure ranging from -43 to +39 mmHg and diastolic blood pressure from -27 to +15 mmHg, indicating its potential effectiveness in managing hypertension.

The study found that the uptake of HBPT was influenced by factors such as blood pressure levels, age, education, and the duration of hypertension, suggesting that these determinants should be considered when implementing HBPT programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Differentiated Effects and Determinants of Home Blood Pressure Telemonitoring: Three-Year Cohort Study in Jieshou, Anhui, China. Xue, Q., Zhang, X., Liu, R., et al.[2022]

Home blood pressure telemonitoring (HBPT) with automatic data transmission significantly reduces blood pressure, with an average decrease of 6.0 mm Hg in systolic blood pressure compared to traditional management methods.

Using smartphone applications for HBPT enhances blood pressure reduction even further, indicating that digital tools can improve hypertension management and support long-term treatment strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Automatic transmission of home blood pressure data can be effective in managing hypertension: a systematic review and meta-analysis. Kaihara, T., Intan-Goey, V., Scherrenberg, M., et al.[2023]

Home blood pressure telemonitoring (HBPT) significantly improved blood pressure control, reducing systolic blood pressure by 4.71 mmHg and diastolic blood pressure by 2.45 mmHg compared to usual care, with a higher proportion of patients achieving normalized blood pressure levels.

While HBPT led to increased healthcare costs per patient, it also improved the physical quality of life and did not increase the risk of adverse events, suggesting it is a beneficial but more expensive option for managing hypertension.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical usefulness and cost effectiveness of home blood pressure telemonitoring: meta-analysis of randomized controlled studies. Omboni, S., Gazzola, T., Carabelli, G., et al.[2023]

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]

Home blood pressure (BP) monitoring is a valuable tool for managing hypertension in patients with chronic kidney disease (CKD), as it provides more accurate and comprehensive data compared to traditional office or dialysis unit measurements.

Using home BP monitoring can lead to better management of hypertension in CKD patients, which is crucial due to their increased risk of cardiovascular disease and stroke.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Home blood pressure monitoring in CKD. Cohen, DL., Huan, Y., Townsend, RR.[2014]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9218433/

A Systematic Review and Meta-Analysis - PMC Home blood pressure telemonitoring is associated with mild lowering of BP and moderately improved kidney function in patients with CKD. However, ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04098354

Telemonitoring of Hypertensive Patients With Chronic ... Several studies in patients without kidney disease have demonstrated the efficacy of home BP telemonitoring (HBPT) for BP control. Objective: The primary aim of ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2468024925000531

Improving Blood Pressure in High-Risk Patients With CKD ... This RPM hypertension program in patients with CKD was feasible and effective in improving BP, which is promising for increasing equity in hypertension control.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8154939/

Impact of home telemonitoring and management support ... This study will assess the impact of home blood pressure telemonitoring on cardiovascular (CV) and kidney-related outcomes in non-dialysis chronic kidney ...

5. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2701733

Long-term Outcomes of the Effects of Home Blood ... Home blood pressure telemonitoring with pharmacist management lowered blood pressure more than usual care in the first 18 months, but this was not sustained ...

6. ahajournals.org ahajournals.org/doi/10.1161/HYPERTENSIONAHA.121.18153

Home Blood Pressure Telemonitoring With Remote ... This study aimed to evaluate the feasibility, safety, and effectiveness of home BP telemonitoring with remote hypertension management among a ...

7. journals.sagepub.com journals.sagepub.com/doi/10.1177/20543581221077500

Telemonitoring and Case Management for Hypertensive ... Poorly controlled blood pressure (BP) is a risk factor for rapid progression of chronic kidney disease (CKD) to kidney failure and is also ...