NCT05844891 Telehealth-Enhanced Asthma Care for Home After the Emergency Room
| NCT ID | NCT05844891 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Rochester |
| Condition | Asthma in Children |
| Study Type | INTERVENTIONAL |
| Enrollment | 430 participants |
| Start Date | 2024-04-01 |
| Primary Completion | 2028-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 430 participants in total. It began in 2024-04-01 with a primary completion date of 2028-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria (all criteria must be met): * Physician diagnosis of asthma, based on review of medical records and/or caregiver report. * Current emergency visit for an acute asthma exacerbation, requiring treatment with rescue medication. * Persistent asthma or poor asthma control for which a daily controller medication is recommended by NHLBI guidelines, defined as any 1 of the following: 1. \>2 days/wk with asthma symptoms in the past month, 2. \>2 days/wk with rescue medication use in the past month, 3. \>2 days/month with nighttime symptoms in the past month (vs. 1-2 nights per month if 3-4 years old), or 4. ≥1 other episode of asthma during the past year that required systemic corticosteroids (vs. during the past 6 months if 3-4 years old). * Child age between ≥3 and ≤12 years. * Child and caregiver live in the greater Rochester, NY metropolitan area (Monroe, Wayne, Ontario, Livingston, Genesee, and Orleans Counties) * Emergency severity index triage scores of 2-5 (total range 1-5; scores of 1 indicate the highest acuity and likelihood of hospitalization). Exclusion Criteria: * 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.
Frequently Asked Questions
Who can join the NCT05844891 clinical trial?
This trial is open to participants of all sexes, aged 3 Years or older, up to 12 Years, studying Asthma in Children. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05844891 currently recruiting?
Yes, NCT05844891 is actively recruiting participants. Visit ClinicalTrials.gov or contact University of Rochester to inquire about joining.
Where is the NCT05844891 trial being conducted?
This trial is being conducted at Rochester, United States.
Who is sponsoring the NCT05844891 clinical trial?
NCT05844891 is sponsored by University of Rochester. The trial plans to enroll 430 participants.
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