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

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. Study investigators will randomize 60 children who have elevated BP (defined as
receipt of ≥1 anti-hypertensive agent or office SBP ≥90th percentile) to either home BP
monitoring with a home SBP target of < 90th percentile or less than 120 mm Hg, which ever is
lower (intervention group) versus usual care group in 2:1 ratio. This study aims to (1)
compare the safety of BP lowering in intervention versus usual care patients, (2) determine
the efficacy of the intervention and provide estimates for the refinement of sample size
determination for an eventual full-scale trial, and (3) assess the feasibility and
acceptability of the intervention, recruitment rates, and barriers to trial completion.

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