RECRUITING

Telehealth-Enhanced Asthma Care for Home After the Emergency Room

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The investigators propose a randomized controlled trial of Telehealth-Enhanced Asthma Care for Home After the Emergency Room (TEACH-ER) vs. enhanced care (EC). TEACH-ER includes: 1) brief, pictorial, and health literacy-informed asthma education in the ED, with color- and shape-coded labels provided for home asthma medications; 2) virtual primary care follow-up within 1 week of discharge using in-home telemedicine (Zoom) when possible, featuring provider prompts for guideline-based preventive therapy and home delivery of prescribed medications with pictorial action plans; 3) two additional in-home virtual visits to reinforce teaching, review treatment plans, label medications, and support effective management practices. The investigators will enroll 430 children (ages 3-12 yrs) from the two dedicated pediatric EDs in our region, and follow all participants for a 12-month period. The investigators will call caregivers to complete blinded follow-up telephone surveys at 3, 6, 9, and 12 months after discharge. The investigators will assess the effectiveness of TEACH-ER in reducing the need for additional asthma-related ED visits or hospitalizations in the 1-months after enrollment. Additional outcomes of interest include asthma symptoms, medication adherence, absenteeism from work and school, quality of life, and the delivery of care consistent with national asthma care guidelines.

Official Title

Telehealth-Enhanced Asthma Care for Home After the Emergency Room (TEACH-ER)

Quick Facts

Study Start:2024-04-01

Study Completion:2028-06-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05844891

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:3 Years to 12 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD

Inclusion Criteria	Exclusion Criteria
Age 18 years or older Willing and able to provide informed consent Able to understand and follow study procedures Stable medical condition	* 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 surveys (either at the subject's home or an easily accessible location). If a subject does not have access to an appropriate device for Zoom visits at home, we will provide a device with required data plan. * Other significant medical conditions, including cystic fibrosis, congenital heart disease, or other chronic lung disease, that could interfere with the assessment of asthma-related measures. * Children in foster care or other situations in which consent cannot be obtained from a legal guardian.

Inclusion Criteria

Exclusion Criteria

Age 18 years or older
Willing and able to provide informed consent
Able to understand and follow study procedures
Stable medical condition

* 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 surveys (either at the subject's home or an easily accessible location). If a subject does not have access to an appropriate device for Zoom visits at home, we will provide a device with required data plan.
* Other significant medical conditions, including cystic fibrosis, congenital heart disease, or other chronic lung disease, that could interfere with the assessment of asthma-related measures.
* Children in foster care or other situations in which consent cannot be obtained from a legal guardian.

Contacts and Locations

Study Locations (Sites)

University of Rochester Medical Center

Rochester, New York, 14642

United States

Collaborators and Investigators

Sponsor: University of Rochester

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-04-01

Study Completion Date2028-06-30

Study Record Updates

Study Start Date2024-04-01

Study Completion Date2028-06-30

Terms related to this study

Additional Relevant MeSH Terms

Asthma in Children