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

Primary Purpose

Chronic Kidney Diseases, Hypertension, Blood Pressure

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
strict blood pressure control
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Kidney Diseases

Eligibility Criteria

13 Years - 30 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of California, San Francisco

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Strict SBP Target

Usual SBP Target

Arm Description

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

Usual care, no home SBP target

Outcomes

Primary Outcome Measures

Achieved Blood Pressure

Secondary Outcome Measures

Number of participants screened who enroll in trial
Feasibility of enrollment

Full Information

First Posted
September 28, 2018
Last Updated
April 26, 2021
Sponsor
University of California, San Francisco
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1. Study Identification

Unique Protocol Identification Number
NCT03691701
Brief Title
Pilot to Examine Risk and Feasibility of Remote Management of BP From Childhood Into Early Adulthood
Acronym
PERFORMANCE2
Official Title
Pilot to Examine Risk and Feasibility of Remote Management of BP From Childhood Into Early Adulthood
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
July 20, 2018 (Actual)
Primary Completion Date
December 31, 2020 (Actual)
Study Completion Date
December 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Diseases, Hypertension, Blood Pressure

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Strict SBP Target
Arm Type
Experimental
Arm Description
Home SBP target < 120 mmHg or 90th percentile for age and height (whichever is lower)
Arm Title
Usual SBP Target
Arm Type
No Intervention
Arm Description
Usual care, no home SBP target
Intervention Type
Other
Intervention Name(s)
strict blood pressure control
Intervention Description
Home SBP target < 120 mmHg or 90th percentile for age and height (whichever is lower)
Primary Outcome Measure Information:
Title
Achieved Blood Pressure
Time Frame
Time Frame: Months 4-12
Secondary Outcome Measure Information:
Title
Number of participants screened who enroll in trial
Description
Feasibility of enrollment
Time Frame
Months 0-12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elaine Ku, MD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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