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临床试验/NCT04995692
NCT04995692已完成不适用

Telehealth Education for Asthma Connecting Hospital and Home (TEACHH) Pilot Study

University of Rochester2 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2021年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
26
试验地点
2
主要终点
Asthma-related hospitalizations and emergency department visits after discharge

研究概览

简要总结

The goal of this study is to evaluate the feasibility, acceptability, and preliminary efficacy of a technology-enhanced educational intervention for caregivers and children who are hospitalized due to asthma. We will conduct a pilot RCT with 60 children (5-13 yrs) hospitalized with asthma at the Golisano Children's Hospital in Rochester, NY. After baseline assessment, subjects will be randomized to either: 1) the Telehealth Education for Asthma Connecting Hospital and Home (TEACHH) intervention, which includes inpatient child/caregiver education using pictorial materials, color/shape labels for home medications (green star=controller, yellow/red circles=rescue), and a pair of in-home, smartphone-based telehealth visits after discharge to reinforce effective home management; or, 2) the standard care (SC) condition, which features standard inpatient education and routine outpatient follow-up. Patients in TEACHH will also receive all SC measures. All caregivers will complete blinded telephone follow-up assessments at 2, 4, and 6 months after discharge; children will be asked medication questions at baseline and 6 months. We will describe the feasibility and acceptability of implementing the TEACHH intervention by reviewing process measure data collected throughout the study; assess the preliminary efficacy of TEACHH in improving key clinical outcomes, including asthma-related ACU at 7 days, 30 days, and 6 months (per electronic health record documentation) and symptom-free days at each follow-up (reported by caregivers); and assess secondary clinical and functional outcomes including asthma-related quality of life, missed school or work due to asthma, caregiver and child medication knowledge, and reported adherence. We will also invite all caregivers to complete a semi-structured qualitative interview (1 month after baseline for the TEACHH group, 6 months after baseline for the SC group). Findings from this work will establish a strong foundation for a full-scale trial, and guide future efforts to deliver guideline-based asthma care to underserved children and families at the greatest risk for preventable morbidity.

详细描述

Study Design:

The investigators propose a 2-year pilot randomized trial of the TEACHH intervention vs. Standard Care (SC). We will enroll 60 children (5-13 years) with persistent asthma who are hospitalized at a tertiary care children's hospital with an acute asthma exacerbation. These children will be systematically screened, and those eligible approached for enrollment. After enrollment, participants will be randomly assigned to TEACHH or SC. We will measure feasibility continuously, and measure preliminary efficacy at 2, 4, and 6 months after enrollment. All caregivers will be invited to complete an additional in-depth interview to solicit feedback on the TEACHH intervention, and better understand family experiences with asthma management, educational support, and unmet home needs. We aim to conduct at least 20 interviews among caregivers in the TEACHH group, and 20 interviews among caregivers in the SC group.

Subjects and Setting:

Children aged 5-13 years will be screened for eligibility following admission to the Golisano Children's Hospital, a tertiary care institution in Rochester, NY. Eligibility will require persistent asthma severity (as per national guidelines) and a primary or secondary hospital diagnosis of asthma. We plan to enroll 60 children and caregiver dyads over a 12-month period. The mean length of stay at GCH for children with primary or secondary diagnoses of asthma is 3.8 days (1.9 days for primary diagnoses), ensuring ample time for study procedures. According to hospital census data, 386 children 5-13 years old with asthma are admitted for inpatient asthma care each year (128 primary diagnoses, 258 secondary diagnoses). We anticipate that at least 75% of these children (~290) will have persistent asthma symptoms and will be eligible for the pilot study, and we aim to enroll approximately 28% of the eligible children hospitalized within a 12-month timeframe.

These ages were chosen because: 1) younger children suffer the largest burden of asthma morbidity, 2) young children are at high risk for inadequate therapy for asthma, 3) children at age 5y are beginning to participate in medicine use, and 4) children in their mid-teenage have different medical and developmental needs compared to younger children, with different co-management roles with their parents that shift toward increased independence. The pictorial lessons, hands-on interactive demonstration of medication technique, and application of stickers to medications are all developmentally appropriate activities for this group of children.

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 (Outcomes Assessor)

盲法说明

Research assistants conducting telephone follow-up assessments 2, 4, and 6 months after enrollment will be blinded to group allocation.

入排标准

年龄范围
5 Years 至 13 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • An inability to speak and understand English. Parents and children with low literacy / health-literacy skills will be eligible, as survey instruments will be administered verbally and educational materials will be designed for low-literacy populations.
  • No access to a working phone for follow-up survey assessments.
  • No access to a smartphone (or other 'smart' device) for telehealth education.
  • Another significant medical condition, including Cystic Fibrosis, congenital heart disease, or other chronic lung disease, that could interfere with assessment of asthma-related measures.
  • A diagnosed developmental condition (e.g. Autism spectrum disorder or significant developmental delay) identified in the child's medical record that could interfere with a child's ability to participate in teaching activities, and/or potentially delay the transition of responsibility for inhaled asthma medications from caregiver to child.
  • If the child or family is currently enrolled in a study conducted by The Preventive Care Program for Urban Children with Asthma (led by Dr. Jill Halterman).

结局指标

主要结局

Asthma-related hospitalizations and emergency department visits after discharge

时间窗: 6 months after discharge

Asthma-related hospitalizations or emergency department visits, and drawn from objective healthcare utilization data in the electronic health record.

Symptom-Free Days (SFD) in the past 2 weeks

时间窗: 6 months

The number of 24-hour periods within the previous 14 days that a child remained free of asthma symptoms (range: 0-14 days); a higher score indicates more days without symptoms. Reported by caregivers during scheduled telephone assessments (2, 4, and 6 months after discharge)

次要结局

  • Caregiver quality of life(2 months, 4 months, 6 months)
  • Missed school due to asthma in the past 2 weeks(2 months, 4 months, 6 months)
  • Missed work due to asthma in the past 2 weeks(2 months, 4 months, 6 months)
  • Caregiver-reported Asthma-related Acute Care Utilization (ACU)(7 days, 30 days, and 6 months after discharge)
  • Caregiver-reported Asthma control (NHLBI)(2 months, 4 months, and 6 months)
  • Caregiver-reported Medication adherence(2 months, 4 months, 6 months)
  • Caregiver-reported Asthma-related outpatient care(2 months, 4 months, and 6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sean Frey

Assistant Professor

University of Rochester

研究点 (2)

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