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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03691701
Recruitment Status : Recruiting
First Posted : October 2, 2018
Last Update Posted : August 27, 2020
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Chronic Kidney Diseases Hypertension Blood Pressure Other: strict blood pressure control Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Pilot to Examine Risk and Feasibility of Remote Management of BP From Childhood Into Early Adulthood
Actual Study Start Date : July 20, 2018
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. Achieved Blood Pressure [ Time Frame: Time Frame: Months 4-12 ]

Secondary Outcome Measures :
  1. Number of participants screened who enroll in trial [ Time Frame: Months 0-12 ]
    Feasibility of enrollment



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   13 Years to 30 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03691701


Contacts
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Contact: Elaine Ku, MD 415-353-2507 Elaine.Ku@ucsf.edu
Contact: Divya Seth, BA 916-476-2041 divya.seth@ucsf.edu

Locations
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United States, California
University of California, San Francisco Recruiting
San Francisco, California, United States, 94143
Contact: Divya Seth, BA    415-501-0385    divya.seth@ucsf.edu   
Sponsors and Collaborators
University of California, San Francisco
Investigators
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Principal Investigator: Elaine Ku, MD University of California, San Francisco
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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT03691701    
Other Study ID Numbers: 17-22758
First Posted: October 2, 2018    Key Record Dates
Last Update Posted: August 27, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency