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临床试验/NCT05991115
NCT05991115
招募中
不适用

The Hospital to Home Study: A Pragmatic Trial to Optimize Transitions and Address Disparities in Asthma Care

Kavita Parikh1 个研究点 分布在 1 个国家目标入组 340 人2024年1月22日

概览

阶段
不适用
干预措施
Standard of Care
疾病 / 适应症
Asthma
发起方
Kavita Parikh
入组人数
340
试验地点
1
主要终点
Number of Re-admissions
状态
招募中
最后更新
上个月

概览

简要总结

Caregiver-child dyads will be recruited during child's hospital admission for asthma exacerbation. Recruitment sites will be mainly Children's National Hospital Sheikh Zayed campus, as well as regional partners: Holy Cross Hospital, and Mary Washington Hospital. After enrollment, baseline data will be collected from caregiver. Caregiver-child dyads will be randomized (1:1 ratio) into the control arm or intervention arm. Control arm will receive the standard of care after hospital discharge. Intervention arm will receive the SOC plus an asthma navigator support after hospital discharge. Caregivers in both arms will complete data collection surveys (either in-person or via telehealth) at 3-,6-, 9-, and 12- month post enrollment.

注册库
clinicaltrials.gov
开始日期
2024年1月22日
结束日期
2027年7月1日
最后更新
上个月
研究类型
Interventional
研究设计
Parallel
性别
All

研究者

发起方
Kavita Parikh
责任方
Sponsor Investigator
主要研究者

Kavita Parikh

Associate Professor of Pediatrics

Children's National Research Institute

入排标准

入选标准

  • speak English or Spanish
  • are at least 18 years old
  • live in the District of Columbia, Maryland, or Virginia (DMV)
  • have a child aged 4-12 years who is hospitalized due to asthma exacerbation.

排除标准

  • . Children ages 4-12 years with chronic medical condition (other than asthma) including but not limited to diabetes, sickle cell disease, heart disease, lung disease or neurological disorder
  • . Children ages 4-12 years involved in interventions with behavioral component and/or novel asthma therapeutics will be excluded given overlap with the current intervention
  • . Children ages 4-12 years in foster care
  • . Families not residing in the DMV
  • . Caregivers who do not speak English or Spanish

研究组 & 干预措施

Standard of Care

Control arm will receive the standard of care (SOC) after hospital discharge.

Hospital to Home Transition (H2H)

The intervention for this study is a multi-component navigation-supported intervention for children hospitalized with asthma. Navigators will work with families for 12-months post-discharge. Trained asthma educator/navigators will work to address challenges with asthma care after discharge; will include maximum 15 contacts/12 months. The asthma navigators within this study will attempt to maintain direct contact with participants primary care doctors through email, fax, and/or postal mail as means for delivering asthma action plans, prescription updates, and patient appointment scheduling. The asthma navigators for intervention participants will attempt to maintain contact with the school nurse in efforts to have a line of communication with the school. Asthma navigators will assist families in all home-based needs pertaining to their child's asthma.

干预措施: Hospital to Home Transition (H2H)

结局指标

主要结局

Number of Re-admissions

时间窗: 3, 6, 9, 12 months

Asthma-related readmissions over 12-month follow-up period from index hospitalization

次要结局

  • Number of Emergency Department (ED) Visit(3, 6, 9, 12 months)
  • Asthma Control Test (ACT)(3, 6, 9, 12 months)
  • Number of Household Triggers(3, 6, 9, 12 months)
  • Parent Self-Efficacy(3, 6, 9, 12 months)
  • Caregiver quality of life(3 ,6, 9, 12 months)
  • Caregiver Stress(3, 6, 9, 12 months)
  • Parental Resilience(3, 6, 9, 12 months)
  • Symptom Free Days (SFD)(3, 6, 9, 12 months)

研究点 (1)

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