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

Trial Summary

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. ^{1 2 3 4 5}

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. ^{1 2 6 7 8}

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. ^{1 2 7 8 9}

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.

Research Team

Aminu Bello, MD PhD

Principal Investigator

University of Alberta

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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 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 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 (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]

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]

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]

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]

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]

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

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

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

Clinical usefulness and cost effectiveness of home blood pressure telemonitoring: meta-analysis of randomized controlled studies. [2023]

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]

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]

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

Home blood pressure monitoring in CKD. [2014]