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临床试验/NCT04171999
NCT04171999已完成不适用

CommunityRx-Hunger: A Hospital-based Intervention for Primary Caregivers of Children Admitted to the Hospital

University of Chicago1 个研究点 分布在 1 个国家目标入组 660 人开始时间: 2020年1月6日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
660
试验地点
1
主要终点
(Aim 1) Caregiver Self-efficacy at 12 Months Among Food Insecure Caregivers

研究概览

简要总结

CommunityRx-Hunger (CRx-H) is a hospital-based intervention that addresses food insecurity and other health-related social needs such as transportation, housing, utilities, and safety. Study team members are recruiting caregivers at the time of their child's hospital admission at a large urban children's hospital. For Aim 1, the primary outcome is self-efficacy among food insecure caregivers compared to those who receive the usual standard of care. For Aim 2, the primary outcome is satisfaction with care compared between food secure and food insecure caregivers.

详细描述

CommunityRx-Hunger (CRx-H) is a double-blinded randomized controlled trial aimed at increasing self-efficacy among caregivers with food insecurity in the household. CRx-H is recruiting primary caregivers of hospitalized children at a large urban children's hospital at the time of admission. Aim 1: Researchers are studying whether the intervention will increase self-efficacy among food insecure caregivers compared to those who receive the usual standard of care. Aim 2: Researchers will enroll and randomize caregivers with and without food insecurity to the intervention to compare satisfaction with care.

Eligible, self-identified caregivers will complete a baseline survey during the child's hospital stay, followed by phone surveys at 7, 30, 90, 180 days, and 12 months. Caregivers randomized to the intervention will receive a tailored list of resources to address food insecurity and other health-related social needs, plus a brief educational component delivered by a trained member of our research team. Cases will receive a "booster" dose of the resource list prior to discharge. After discharge, cases will receive proactive text messages about those same community resources.

All caregivers (regardless of research arm) will receive a series of text messages related to the study such as reminders to schedule the phone survey with a member of the research team.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Double (Participant, Outcomes Assessor)

盲法说明

Double-Blind randomized controlled trial where the data collectors are blinded to the condition to which the subject has been assigned. The subject is also blinded to the condition they are assigned.

入排标准

性别
All
接受健康志愿者

入选标准

  • Native English or Spanish speaker
  • Living in 1 of 27 zip codes in the study's target region
  • Self-identify as a primary caregiver of a child <18 years old hospitalized in a large urban children's hospital
  • Ability to send and receive text messages
  • Access to a mobile phone and agrees to receive text messages from the study

排除标准

  • Previous participation in a CRx research study.
  • Caregivers of newborns in the hospital
  • Patient hospital stay is less than 24 hours
  • Patient hospital stay is 30 days or more
  • Patient has an eating disorder as indicated in the EMR

研究组 & 干预措施

Usual Care + Intervention (Case)

Experimental

Cases will receive the CommunityRx Intervention.

干预措施: Community Rx-Hunger (CRx-H) (Other)

Usual Care (Control)

No Intervention

Controls will receive the usual standard care, which consists of information about hospital food resources and access to Feed1st hospital food pantries prior to discharge.

结局指标

主要结局

(Aim 1) Caregiver Self-efficacy at 12 Months Among Food Insecure Caregivers

时间窗: 12 months

Self-efficacy is measured by Bandura's Self-Efficacy Scale which asks, "How confident are you in your ability to find resources in your community that help you manage your health?" Responses will be assessed on a 5-point Likert scale ranging from "not at all confident" to "completely confident."

(Aim 2) Caregiver Satisfaction With Hospital Discharge

时间窗: 7 days post discharge from the hospital

Satisfaction with hospital discharge is measured by the Hospital Consumer Assessment of Healthcare Providers Survey (HCAHPS); "Child HCAHPS" which includes 8 items (range 0-100 with higher values representing higher satisfaction). Response options are "Yes, definitely," "Yes, somewhat" and "No." The items ask about the child and the hospital related to their recent stay.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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