Telehealth Education for Asthma Connecting Hospital and Home
NCT04995692 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 26
Last updated 2023-11-28
Summary
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.
Conditions
- Asthma in Children
Interventions
- BEHAVIORAL
-
Telehealth Education for Asthma Connecting Hospital and Home
TEACHH aims to provide educational support to families managing childhood asthma throughout the transition from hospital to home, and includes several core components: 1) Health literacy-informed inpatient teaching for child and caregiver including pictorial materials, hands-on demonstration, and use of teach-back/show-back techniques; 2) Facilitated identification of rescue and controller medications using color- and shape-coded medication labels and a pictorial asthma action plan; and 3) A pair of virtual follow-up visits after discharge to reinforce inpatient teaching and support families during the shift from acute exacerbation to preventive care management. Virtual visits will be completed using the Zoom platform on smartphones or other compatible devices, 2-4 days after discharge (first visit) and 3 weeks after discharge (second visit). All intervention activities will be completed within 1 month of discharge.
- BEHAVIORAL
-
Standard Care (SC) Comparison Group
Patients in the SC group will receive standard impatient management, including pre-recorded asthma education videos shown prior to discharge and the hospital action plan. PCP follow-up with be scheduled within a week of discharge. All SC measures will also be provided to subjects randomized to TEACHH.
Sponsors & Collaborators
-
Agency for Healthcare Research and Quality (AHRQ)
collaborator FED -
American Lung Association
collaborator OTHER -
University of Rochester
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- HEALTH_SERVICES_RESEARCH
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 5 Years
- Max Age
- 13 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-11-01
- Primary Completion
- 2022-12-31
- Completion
- 2023-09-30
Countries
- United States
Study Locations
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