Telemonitoring of Hypertensive Patients With Chronic Kidney Disease

Summary

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.

Conditions

• Chronic Kidney Diseases

Interventions

DIAGNOSTIC_TEST

home BP telemonitoring system .

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.

Sponsors & Collaborators

• University of Alberta

  lead OTHER

Principal Investigators

• Aminu Bello · University of Alberta

Study Design

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-04-15

Primary Completion

2026-12-31

Completion

2026-12-31

Countries

• Canada

Study Locations