Pilot to Examine Risk and Feasibility of Remote Management of BP From Childhood Into Early Adulthood
赞助:
University of California, San Francisco
合作者:
信息的提供 (责任方):
Elaine Ku, MD，University of California, San Francisco
| 追踪信息 | |||
|---|---|---|---|
| 首次提交日期 ICMJE | September 28, 2018 | ||
| 首次发布日期e ICMJE | October 2, 2018 | ||
| 最后更新发布日期 | October 3, 2018 | ||
| 预计研究开始日期 ICMJE | July 20, 2018 | ||
| 预计主要完成日期 | July 2020 (主要结果测量的最终数据收集日期) | ||
| 目前主要观察指标 ICMJE |
Achieved Blood Pressure[ Time Frame: Time Frame: Months 4-12 ] |
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| 原始主要观察测量 ICMJE | 与当前相同 | ||
| 目前的二级观察 ICMJE |
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| 描述性信息 | |||
| 简略标题 ICMJE | Pilot to Examine Risk and Feasibility of Remote Management of BP From Childhood Into Early Adulthood | ||
| 正式标题 ICMJE | Pilot to Examine Risk and Feasibility of Remote Management of BP From Childhood Into Early Adulthood | ||
| 简要概况 | 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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| 详细说明 | 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. | ||
| 研究类型 ICMJE | Interventional | ||
| 研究阶段 | Phase 2 | ||
| 研究设计 ICMJE | 分配: Randomized 干预模型: Parallel Assignment 干预模型描述: 盲法: Interventional 盲法描述: 主要目的: Treatment |
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| 适用条件 ICMJE | |||
| 干预项目 ICMJE |
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| 研究工具 |
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| 招募信息 | |||
| 招募状态 ICMJE | Recruiting | ||
| 预计入组 ICMJE |
60 | ||
| 原始预计入组 ICMJE | 与当前相同 | ||
| 预计研究完成日期 | July 2020 | ||
| 预计主要完成日期 | July 2020 (主要结果测量的最终数据收集日期) | ||
| 合格标准 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 | ||
| 性别 |
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| 年龄 | 最小年龄：13 Years ，最大年龄：30 Years | ||
| 接受健康的志愿者 | 没有 | ||
| 可入组国家 ICMJE | United States | ||
| 管理信息 | 数据检测委员会 | Yes | |
| 研究涉及美国FDA监管的产品 |
研究美国FDA监管的药品: No 研究涉及美国FDA监管的设备产品: No |
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| IPD 共享声明 |
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| 责任方 | Elaine Ku, MD，University of California, San Francisco | ||
| 研究赞助商 ICMJE | University of California, San Francisco | ||
| 合作者 ICMJE | |||
| 研究员 ICMJE |
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| PRS 账户 | University of California, San Francisco | ||
| 验证日期 | October 2018 | ||
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ICMJE 国际医学期刊编辑委员会和 世界卫生组织 ICTRP 要求的元素 |
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