Pilot to Examine Risk and Feasibility of Remote Management of BP From Childhood Into Early Adulthood
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Achieved Blood Pressure
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 13 Years 至 30 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
Strict SBP Target
Home SBP target < 120 mmHg or 90th percentile for age and height (whichever is lower)
干预措施: strict blood pressure control (Other)
Usual SBP Target
Usual care, no home SBP target
结局指标
主要结局
Achieved Blood Pressure
时间窗: Time Frame: Months 4-12
次要结局
- Number of participants screened who enroll in trial(Months 0-12)