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

Not Applicable

Completed

• Conditions: Chronic Kidney Diseases; Blood Pressure; Hypertension
• Interventions: Other: strict blood pressure control

• Registration Number: NCT03691701
• Lead Sponsor: University of California, San Francisco

Brief 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.

Detailed Description

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.

Study Timeline

• Study Start: 2018-07-20
• Study First Submitted: 2018-09-28
• Study First Submitted QC: 2018-09-28
• Study First Posted: 2018-10-02
• Primary Completion: 2020-12-31
• Study Completion: 2020-12-31
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-26
• Last Update Posted: 2021-04-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Strict SBP Target	strict blood pressure control	Home SBP target \< 120 mmHg or 90th percentile for age and height (whichever is lower)

Primary Outcome Measures

Name	Time	Method
Achieved Blood Pressure	Time Frame: Months 4-12

Secondary Outcome Measures

Name	Time	Method
Number of participants screened who enroll in trial	Months 0-12	Feasibility of enrollment

Trial Locations

Locations (1)

University of California, San Francisco; 🇺🇸 San Francisco, California, United States