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临床试验/NCT04682015
NCT04682015Unknown不适用

Effect of a WeChat Platform-based Management Intervention on Blood Pressure Control: A Randomized Clinical Trial.

First Affiliated Hospital of Wenzhou Medical University0 个研究点目标入组 436 人开始时间: 2021年2月18日最近更新:
适应症

试验速览

阶段
不适用
入组人数
436
主要终点
Proportion with controlled blood pressure at 12 months (defined by ambulatory blood pressure monitoring )

研究概览

简要总结

WeChat is the largest and most popular social media platform in China, In this study, investigators will evaluate the use of management program delivered via WeChat platform in patients with hypertension.

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
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients aged ≥ 18 years with confirmed diagnosis of hypertension
  • Office systolic blood pressure (SBP)≥140 mmHg and/or diastolic blood pressure (DBP)≥90 mmHg, or ambulatory blood pressure monitoring (ABPM) indicating 24- hour SBP ≥130 mmHg and/or DBP ≥80 mmHg and/or daytime SBP ≥135 mmHg and/or DBP ≥85 mmHg and/or nocturnal SBP ≥120 mmHg and/or DBP ≥70 mmHg.
  • Patients have smart phone and often use WeChat to communicate with others (including written interaction)
  • Patients are willing and able to give informed consent for participation in the trial

排除标准

  • Secondary hypertension
  • Hypertensive emergency: defined as severe elevations in BP (SBP ≥180 mmHg and/or DBP≥120mmHg) associated with evidence of new or worsening target organ damage, including hypertensive encephalopathy, intracranial hemorrhage, cerebral hemorrhage, subarachnoid hemorrhage, cerebral infarction, heart failure, acute coronary syndrome (unstable angina, acute myocardial infarction), aortic dissection, perioperative hypertension, preeclampsia, and eclampsia
  • Refractory hypertension: defined as failure to control BP despite lifestyle changes and use of at least 5 antihypertensive agents of different classes, including a thiazide-type diuretic and a mineralocorticoid receptor antagonist
  • Pregnancy or lactation or having pregnancy plan during the study period
  • Life expectancy less than 1 year
  • Participation in another clinical study or clinical trial in the 3 months prior to the confirmation of eligibility or current user of WeChat platform provided by hypertension center of the first affiliated hospital of Wenzhou medical university

结局指标

主要结局

Proportion with controlled blood pressure at 12 months (defined by ambulatory blood pressure monitoring )

时间窗: 12 months

mean 24-hour ambulatory blood pressure monitoring (ABPM) \<130/80 mmHg, day time blood pressure \<135/85 mmHg, and nocturnal blood pressure \<120/70 mmHg

次要结局

  • Systolic blood pressure (mmHg) at 12 months(12 months)
  • Medication adherence at 12 months(12 months)
  • Diastolic blood pressure (mmHg) at 12 months(12 months)

研究者

申办方类型
Other
责任方
Sponsor

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