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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Chronic Kidney Diseases, Hypertension, Blood Pressure

Intervention / Treatment
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* Other: strict blood pressure control


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 13 Years
Maximum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Strict SBP Target<br>Home SBP target < 120 mmHg or 90th percentile for age and height (whichever is lower) | Other: strict blood pressure control<br>* Home SBP target < 120 mmHg or 90th percentile for age and height (whichever is lower)<br>|
| No Intervention: Usual SBP Target<br>Usual care, no home SBP target | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Achieved Blood Pressure |  | Time Frame: Months 4-12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants screened who enroll in trial | Feasibility of enrollment | Months 0-12 |