Telemonitoring for Hypertension in Chronic Kidney Disease

N/A

Recruiting

Led By Aminu Bello

Research Sponsored by University of Alberta

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up upto 12 months

Summary

This trial will assess the mean difference in systolic blood pressure at 12 months, from baseline in remote dwelling patients with hypertension and chronic kidney disease in Northern Alberta, Canada, comparing home blood pressure telemonitoring + usual care versus telemonitoring + a case manager.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

There may be no direct side effects from participating since it involves monitoring rather than medication changes; however, potential issues include technological challenges or privacy concerns related to data transmission.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ upto 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~upto 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and upto 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Effectiveness of telemonitoring and protocol-based case management versus usual care

Secondary study objectives

Proportion of patients with systolic blood pressure within guideline target, user acceptability, adverse events, cost-effectiveness and utility.

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: home-based BP telemonitoringActive Control1 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 carePlacebo Group1 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.

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