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

NCT03691701 | Completed DMC

• 1 other identifier: 17-22758
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Kidney Diseases; Hypertension; Blood Pressure

Outcome Measures

Primary Outcomes (1)

• Achieved Blood Pressure

  Time Frame: Months 4-12

Secondary Outcomes (1)

• Number of participants screened who enroll in trial

  Months 0-12

Study Arms (2)

Strict SBP Target

EXPERIMENTAL

Home SBP target \< 120 mmHg or 90th percentile for age and height (whichever is lower)

Other: strict blood pressure control

Usual SBP Target

NO INTERVENTION

Usual care, no home SBP target

Interventions

strict blood pressure control OTHER

Home SBP target \< 120 mmHg or 90th percentile for age and height (whichever is lower)

Strict SBP Target

Eligibility Criteria

• Age: 13 Years - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94143, United States

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Hypertension

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Elaine Ku, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2018
• First Posted: October 2, 2018
• Study Start: July 20, 2018
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: April 28, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)