跳至主要内容
临床试验/NCT05197608
NCT05197608招募中不适用

At-risk and vulNerable Individuals To Infection With COVID-19 and ProActive inTervention With intEgrated Health and Social Care (ANTICIPATE): a Pragmatic Randomized Controlled Trial

Unity Health Toronto2 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2022年2月25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
180
试验地点
2
主要终点
Emotional Distress on the PROMIS-29 Profile c2.1 Scale

研究概览

简要总结

This randomized control trial aims to explore a data-driven, proactive approach to identifying patients at greatest risk during the pandemic, and assess the impact of an embedded System Navigator in a primary health care setting. The System Navigator works one-on-one with patients to identify and provide support to their biological, psychological and social needs (e.g. income, housing, food security). Investigators are doing this study to find out whether proactive identification of vulnerable patients and linking to a System Navigator leads to reduction in emotional distress associated with managing complex health conditions and unmet social needs during COVID-19, compared to usual care.

Investigators will involve approximately 180 patients from primary care clinics that are a part of the University of Toronto Practice-Based Research Network (UTOPIAN). The information from this study will be used to help us understand how proactive engagement within a primary health setting can help to improve the health of patients during COVID-19, and beyond.

研究设计

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

入排标准

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

入选标准

  • At-risk and vulnerable patients of primary care organizations who are 60+ AND have one or more of:
  • chronic condition (diabetes, CHF, CAD, COPD or asthma)
  • serious mental illness (schizophrenia or bipolar disorder)
  • anticipated to live in poverty and/or be homeless/underhoused

排除标准

  • patients unable to provide informed consent

结局指标

主要结局

Emotional Distress on the PROMIS-29 Profile c2.1 Scale

时间窗: 3 months

Measure of emotional distress as measured by anxiety and depression systems

次要结局

  • Social needs met(3 months)
  • COVID related outcomes (patient-reported questionnaire built for this study)(3 months)
  • Mortality related to COVID-19 and all cause mortality(12 months)
  • Number of hospitalizations related to COVID-19 and all cause mortality(12 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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