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Behavioural Intervention
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
Awards & highlights
Study 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.Check my eligibility
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.See study design
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Effectiveness of telemonitoring and protocol-based case management versus usual care
Secondary outcome measures
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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Who is running the clinical trial?
University of AlbertaLead Sponsor
889 Previous Clinical Trials
384,988 Total Patients Enrolled
Aminu BelloPrincipal InvestigatorUniversity of Alberta
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Eligibility Criteria:
This trial includes the following eligibility criteria:- If you have a sudden and severe increase in blood pressure during the study, you will need to see your primary care doctor or a specialist right away.People who live far away in the Peace River region of Alberta, Canada.You have been diagnosed with high blood pressure and are currently taking medication for it.You have severe kidney disease or are receiving kidney replacement therapy.You have heart failure with a decreased ability to pump blood.You are 18 years or older and have been diagnosed with chronic kidney disease, but you are not on dialysis and have a lower than normal kidney function or high levels of protein in your urine.
Research Study Groups:
This trial has the following groups:- Group 1: home-based BP telemonitoring
- Group 2: usual care
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there still spots available for patients who want to participate in this trial?
"Yes, this trial appears to be ongoing, according to the information available on clinicaltrials.gov. The trial was created on 4/15/2022, and the most recent update was on 7/27/2022. The study needs to find 146 people total, but is only searching at 1 site."
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