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临床试验/NCT05479461
NCT05479461招募中不适用

A Two-arm Parallel Randomized Clinical Trial of Implementation of Technology-enabled Management Versus Usual Care for Blood Pressure

Stanford University6 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2023年6月13日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
200
试验地点
6
主要终点
Defined Daily Dose (DDD)

研究概览

简要总结

Two arm parallel randomized clinical trial

详细描述

For this study, we have 3 cohorts that employ varying recruitment strategies before they are enrolled in the interventions.

At Stanford, we have 2 cohorts, where Cohort 1 is recruiting participants through clinic screening and contacting them through text or email.

For Cohort 2, recruitment is divided into two phases: Control Phase I and Intervention Phase II. During Control Phase I, standard recruitment methods were employed, including general outreach through participating clinics and pre-existing clinical networks. These efforts did not incorporate specific strategies aimed at enhancing diversity or prioritizing underrepresented populations. In contrast, Intervention Phase II introduced four targeted strategies designed to improve the inclusion of African-American, Hispanic/Latinx individuals, and women.

  1. Digital Outreach via BuildClinical: The study leverages a digital recruitment campaign managed by BuildClinical, utilizing targeted online advertisements across various platforms. Prospective participants who engage with the advertisements are directed to a study landing page, where they receive detailed study information and complete a preliminary eligibility screening before being contacted by the study team.
  2. Patient Registry-Based Recruitment: Eligible participants will be identified through structured data queries from the STAnford Research Repository (STARR) or EPIC registry. This approach ensures targeted outreach to individuals who meet the study's inclusion criteria while reducing screening burden.
  3. Honest Broker Outreach via Stanford RPEP: To maintain privacy compliance, the Stanford Research Participant Engagement Program (RPEP) will conduct Honest Broker outreach via multiple channels, including secure Epic MyHealth messages, postal mail, and provider co-invitations. This method allows potential participants to opt in or out before direct contact with the research team, ensuring ethical and efficient recruitment.
  4. Spanish-Speaking Ambassador Program: A dedicated Spanish-speaking ambassador will support recruitment efforts by engaging with Spanish-speaking participants, providing culturally tailored study information, and assisting with the informed consent process. This initiative ensures equitable access for Spanish-speaking individuals and facilitates participation among historically underrepresented populations.

Our TIDE site partners at the Morehouse School of Medicine utilize their own recruitment methods for cohort 3, which uses the following:

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
30 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 30-90 yrs.
  • Smartphone ownership
  • Office SBP: ≥ 140 mm Hg
  • ≤ 2 current anti-HTN meds
  • Able to add or dose-increase at least 2 of the following classes of medications: ACE-I/ARB, diuretic, calcium channel blocker, beta-blocker, mineralocorticoid receptor antagonists (i.e., at least 2 classes are available for addition or dose- increases after excluding intolerant medications and medications currently at maximum dose)
  • English or Spanish-speakers

排除标准

  • Heart failure with reduced ejection fraction (EF < 40%)
  • ESRD (GFR <15)
  • Renal replacement therapy
  • Myocardial infarction or stroke within preceding 6 months
  • Hospitalization for hypertensive emergency or malignant hypertension within preceding 6 months
  • Prior solid organ transplantation
  • At the clinical discretion of the investigators
  • Enrolled in another clinical study

结局指标

主要结局

Defined Daily Dose (DDD)

时间窗: Visit 1 (Baseline), Visit-3 (6 Month follow up)

Change in defined daily dose (DDD)

次要结局

  • Diastolic blood pressure (DBP)(Visit-1 (Baseline), Visit-3 (6 Month follow up))
  • Systolic Blood Pressure (SBP)(Visit-1 (Baseline), Visit -2 (3 Month follow up))
  • Antihypertensive Drugs(Visit-1 (Baseline), Visit-3 (6 Month follow up))
  • Physician Survey(Visit 1 (Baseline), Visit-3 (6 Month follow up))
  • Clinician inertia(Visit 1 (Baseline), Visit-3 (6 Month follow up))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Paul Wang

Professor of Medicine (Cardiovascular Medicine), Stanford University Medical Center

Stanford University

研究点 (6)

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