Pilot to Examine Risk and Feasibility of Remote Management of BP From Childhood Into Early Adulthood
Sponsor:
University of California, San Francisco
Collaborators:
Information provided by (Responsible Party):
Elaine Ku, MD，University of California, San Francisco
| Tracking Information | |||
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| First Submitted Date ICMJE | September 28, 2018 | ||
| First Posted Date ICMJE | October 2, 2018 | ||
| Last Update Posted Date | October 3, 2018 | ||
| Actual Study Start Date ICMJE | July 20, 2018 | ||
| Estimated Primary Completion Date | July 2020 (Final data collection date for primary outcome measure) | ||
| Current Primary Outcome Measures ICMJE |
Achieved Blood Pressure[ Time Frame: Time Frame: Months 4-12 ] |
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| Original Primary Outcome Measures ICMJE | Same as current | ||
| Current Secondary Outcome Measures ICMJE |
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| Descriptive Information | |||
| Brief Title ICMJE | Pilot to Examine Risk and Feasibility of Remote Management of BP From Childhood Into Early Adulthood |
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| Official Title ICMJE | Pilot to Examine Risk and Feasibility of Remote Management of BP From Childhood Into Early Adulthood |
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| 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. |
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| 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 ICMJE | Interventional | ||
| Study Phase | Phase 2 | ||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Intervention Model Description: Masking: Interventional Masking Description: Primary Purpose: Treatment |
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| Condition ICMJE | |||
| Intervention ICMJE |
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| Study Arms |
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| Recruitment Information | |||
| Recruitment Status ICMJE | Recruiting | ||
| Estimated Enrollment ICMJE |
60 | ||
| Original Estimated Enrollment ICMJE | Same as current | ||
| Estimated Study Completion Date | July 2020 | ||
| Estimated Primary Completion Date | July 2020 (Final data collection date for primary outcome measure) | ||
| Eligibility Criteria ICMJE | 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 | ||
| Sex/Gender |
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| Ages | 13 Years and older (Adult, Older Adult) | ||
| Accepts Healthy Volunteers | No | ||
| Listed Location Countries ICMJE | United States | ||
| Removed Location Countries | |||
| Administrative Information | Has Data Monitoring Committee | Yes | |
| U.S. FDA-regulated Product |
Studies a U.S. FDA-regulated Drug Product: No Studies a U.S. FDA-regulated Device Product: No |
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| IPD Sharing Statement |
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| Responsible Party | Elaine Ku, MD，University of California, San Francisco | ||
| Study Sponsor ICMJE | University of California, San Francisco | ||
| Collaborators ICMJE | |||
| Investigators ICMJE |
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| PRS Account | University of California, San Francisco | ||
| Verification Date | October 2018 | ||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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