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

Hypertension Clinical Trial

— PERFORMANCE2  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03691701
• Other study ID #: 17-22758
• Status: Completed
• Phase: N/A
• Start date: July 20, 2018
• Est. completion date: December 31, 2020

Study information

• Verified date: April 2021
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years to 30 Years

Eligibility

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

Related Conditions & MeSH terms

• Blood Pressure
• Chronic Kidney Diseases
• Hypertension
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Other:
• strict blood pressure control
Home SBP target < 120 mmHg or 90th percentile for age and height (whichever is lower)

Locations

Country	Name	City	State
United States	University of California, San Francisco	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Achieved Blood Pressure		Time Frame: Months 4-12
Secondary	Number of participants screened who enroll in trial	Feasibility of enrollment	Months 0-12