Pilot to Examine Risk and Feasibility of Remote Management of BP From Childhood Into Early Adulthood (PERFORMANCE2)

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 Overview

• Status: Completed
• Conditions: Hypertension; Chronic Kidney Diseases; Blood Pressure
• Intervention / Treatment: Other: strict blood pressure control

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 Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94143
      • University of California, San Francisco

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years to 30 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: University of California, San Francisco

Study record dates

Study Major Dates

• Study Start (Actual): July 20, 2018
• Primary Completion (Actual): December 31, 2020
• Study Completion (Actual): December 31, 2020

Study Registration Dates

• First Submitted: September 28, 2018
• First Submitted That Met QC Criteria: September 28, 2018
• First Posted (Actual): October 2, 2018

Study Record Updates

• Last Update Posted (Actual): April 28, 2021
• Last Update Submitted That Met QC Criteria: April 26, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Renal Insufficiency; Kidney Diseases; Renal Insufficiency, Chronic
• Other Study ID Numbers: 17-22758

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No