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临床试验/NCT06119152
NCT06119152Unknown不适用

Digital Equity for Stroke Approach Pilot Study

State University of New York - Downstate Medical Center2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2023年10月17日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
80
试验地点
2
主要终点
Blood Pressure Change

研究概览

简要总结

A community-academic partnership composed of a State University of New York (SUNY) Downstate Health Sciences University inter-disciplinary team of scientists (representing public health, medical informatics, vascular neurology/stroke center) and the Digital Equity Community Advisory Board (DECA) will guide our research. This is an NIH R21 pilot study. Our Specific Aims are designed to inform the sample design and research priorities for a larger NIH R01 experimental study and to serve as a platform for similar studies with other health conditions. We propose a mixed-methods study design with the following aims:

  1. Assess and build setting, community, and user fit of DESA, leveraging qualitative methods and simulation telehealth encounters between the patient and neurologist.
  2. Conduct a 9-month pilot randomized control trial (RCT) of DESA in a Central Brooklyn stroke population to examine the feasibility and preliminary efficacy. We will randomize 50 adults to DESA and 30 to usual care. The primary outcome will be BP control. Secondary outcomes include the number of BP measurements and medication compliance. Our primary hypothesis is that patients randomized to the DESA will significantly reduce systolic blood pressure at 9 months.
  3. Examine barriers and facilitators to the adoption and integration of DESA into routine stroke care utilizing key informant interviews and user satisfaction surveys with neurologists and intervention participants.

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

入选标准

  • African American or Afro-Caribbean
  • 18 years or over
  • Experienced a stroke in the last 6 years
  • A score between 2 and 4 on the Modified Rankin Scale2
  • Has a formal or informal caregiver (e.g., relative, health aide or other) to assist them in activities of daily living
  • Has a primary care physician at University Hospital of Brooklyn (UHB)

排除标准

  • Mental illness (severe depression)
  • Non-English speakers
  • severe dysarthria (slurred speech/impediment)

结局指标

主要结局

Blood Pressure Change

时间窗: 9 months

Blood Pressure (Systolic and Diastolic) will be recorded by telehealth device daily

次要结局

  • Number of Blood Pressure readings/week(9 months)
  • Medication Adherence(9 months)

研究者

发起方
State University of New York - Downstate Medical Center
申办方类型
Other
责任方
Sponsor

研究点 (2)

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