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
About this trial
This is an interventional treatment trial for Chronic Kidney Diseases
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
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
NCT ID
NCT03691701
First Posted
September 28, 2018
Last Updated
April 26, 2021
Sponsor
University of California, San Francisco
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
Learn more about this trial
Pilot to Examine Risk and Feasibility of Remote Management of BP From Childhood Into Early Adulthood
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