CompletedNot Applicable

Pilot to Examine Risk and Feasibility of Remote Management of BP From Childhood Into Early Adulthood

United States20 participantsStarted 2018-07-20

Plain-language summary

Hypertension is an increasingly common problem in children, especially among those who are obese or with diabetes and chronic kidney disease. This study is a pilot randomized controlled trial designed to test whether improved blood pressure control can be achieved with the use of remote home blood pressure monitoring in children with uncontrolled blood pressure.

Who can participate

Age range

13 Years – 30 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * must be receiving at least one anti-hypertensive agent or have an office SBP ≥120 mmHg or \>90th percentile for age, sex or height at the time of the screening visit * have a mid-arm circumference between 22-37cm (BP cuff size limitation) * able to provide consent to participate in our study * able to use smartphones, or able to use any phone to call or text our study personnel with home BP readings. If participant does not have a smartphone, they will be allowed to call, text, or e-mail home BP readings on a weekly basis instead. Exclusion Criteria: We will exclude those who: * are or are planning to become pregnant, due to inability to take multiple classes of anti-hypertensive agents * are marginally housed, due to concerns regarding routine follow-up * are actively participating in a different interventional trial that may affect blood pressure * are unwilling to consent to participate * institutionalized individuals or prisoners * are actively abusing illicit drugs or alcohol * have a history of poor or doubtful compliance (e.g., frequently missed appointments) * have office SBP \>170 mmHg * are already taking ≥5 anti-hypertensive medications (any classes, including diuretics) * have cognitive impairment prohibiting participation in the study

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Achieved Blood Pressure

Timeframe: Time Frame: Months 4-12

Trial details

NCT IDNCT03691701

SponsorUniversity of California, San Francisco

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-12-31

View on ClinicalTrials.gov More Chronic Kidney Diseases trials