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临床试验/NCT02746393
NCT02746393已完成不适用

San Francisco General Hospital (SFGH) Health Advocates Phase II Study

University of California, San Francisco2 个研究点 分布在 1 个国家目标入组 1,278 人开始时间: 2016年7月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
1,278
试验地点
2
主要终点
Change in Caregiver Report of Child Health Status Using Pediatric Quality of Life Inventory (Peds QL)

研究概览

简要总结

The San Francisco General Hospital (SFGH) Health Advocate Staff II Study is a Randomized Controlled Trial (RCT) that collects survey data and non-invasive biological data from caregivers and children visiting a pediatric urgent care center. Families will be randomized according to a pre-determined randomization schedule into one of two social needs-focused interventions (the Health Advocates Program or a 211 Information active comparator arm). All patients in the study will be followed over a six month period to capture information about changes in social needs, health and health care utilization.

详细描述

Adverse social circumstances like hunger and food insecurity can have dramatic, negative impacts on the health of vulnerable children. In safety-net settings, the prevalence of these adverse social circumstances are high. The investigators are proposing an RCT on an intervention based in a large urban pediatric urgent care setting that addresses patients' social circumstances. In an earlier RCT conducted in a similar setting, this intervention helped decrease total social needs and parent reported child health on a single item measure. In this study, the investigators will collect a more robust set of survey data including detailed measures of child health and non-invasive biological data from children and caregivers accompanying those children. Families will be randomized according to a pre-determined randomization schedule into the social needs-focused intervention. In one arm, the investigators will offer the intervention, which involves in-person navigation around available social and legal resources; in the other, the investigators will offer written information to participants on available community resources. All patients in both arms will be followed over a six month period to capture information about changes in participants' social needs, health and health care utilization.

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
Single (Participant)

入排标准

性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • Non-English or non-Spanish speaking Parent or Legal Guardian Caregiver;
  • Parent or legal guardian caregiver under age 18;
  • Parent or legal guardian caregiver accompanying patient is not familiar with the child's living situation;
  • Family participated in study previously;
  • Non-San Francisco County resident;
  • Foster child or child in clinic for a child protective clearance exam.

结局指标

主要结局

Change in Caregiver Report of Child Health Status Using Pediatric Quality of Life Inventory (Peds QL)

时间窗: Baseline and 6 months

Collected at baseline and 6 month follow up

Change in Families' Social Needs Using Staff Administered Social Needs Screener

时间窗: Baseline & 6 months

Collected at baseline and 6 month follow up

次要结局

  • Change in caregiver depression using self-report PHQ(Baseline and 6 months)
  • Change in Perceived Social Stress using self-report Perceived Stress Scale(Baseline and 6 Months)
  • Change in caregiver health using PROMIS-10 measures(Baseline and 6 months)
  • Change in hair cortisol in children and caregivers(Baseline and 6 Months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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