Telehealth Education for Asthma Connecting Hospital and Home

NCT04995692 | Completed

• 1 other identifier: 00006450
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (6)

• Asthma-related hospitalizations and emergency department visits after discharge

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

  7 days after discharge

• Asthma-related hospitalizations and emergency department visits after discharge

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

  30 days after discharge

• Asthma-related hospitalizations and emergency department visits after discharge

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

  6 months after discharge

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

  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)

  2 months

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

  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)

  4 months

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

  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)

  6 months

Secondary Outcomes (7)

• Caregiver-reported Asthma-related Acute Care Utilization (ACU)

  7 days, 30 days, and 6 months after discharge

• Caregiver-reported Asthma-related outpatient care

  2 months, 4 months, and 6 months

• Caregiver-reported Asthma control (NHLBI)

  2 months, 4 months, and 6 months

• 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

Study Arms (2)

Telehealth Education for Asthma Connecting Hospital and Home (TEACHH)

EXPERIMENTAL

New model of patient-centered asthma education

Behavioral: Telehealth Education for Asthma Connecting Hospital and Home

Standard Care (SC) Comparison Group

ACTIVE COMPARATOR

Standard inpatient asthma education per hospital protocol.

Behavioral: Standard Care (SC) Comparison Group

Interventions

Telehealth Education for Asthma Connecting Hospital and Home BEHAVIORAL

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.

Also known as: TEACHH

Telehealth Education for Asthma Connecting Hospital and Home (TEACHH)

Standard Care (SC) Comparison Group BEHAVIORAL

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.

Standard Care (SC) Comparison Group

Eligibility Criteria

• Age: 5 Years - 13 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Physician diagnosis of asthma, based on review of medical records.
• Inpatient admission to GCH with asthma as a primary or secondary diagnosis.
• Persistent asthma or poor asthma control for which a daily controller medication is recommended by NHLBI guidelines, defined as any 1 of the following:
• \>2 days per week with asthma symptoms in the past month;
• \>2 days per week with rescue medication use in the past month;
• \>2 days per month with nighttime symptoms in the past month; or
• ≥1 other episode(s) of asthma during the past year that required systemic corticosteroids
• Age between ≥5 and ≤11 years.

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Rochester: lead
• Agency for Healthcare Research and Quality (AHRQ): collaborator
• American Lung Association: collaborator

Study Sites (1)

University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

Related Publications (1)

• Frey SM, Sanchez I, Fagnano M, Milne Wenderlich A, Mammen JR, Halterman JS. The Telehealth Education for Asthma Connecting Hospital and Home (TEACHH) pilot study. J Asthma. 2025 Mar;62(3):416-426. doi: 10.1080/02770903.2024.2408304. Epub 2024 Oct 9.

  PMID: 39352693 DERIVED

MeSH Terms

Interventions

Home Care Services; Standard of Care

Intervention Hierarchy (Ancestors)

Community Health Services; Health Services; Health Care Facilities Workforce and Services; Nursing Services; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Research assistants conducting telephone follow-up assessments 2, 4, and 6 months after enrollment will be blinded to group allocation.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Pilot randomized controlled trial using a parallel design, in which subjects are randomized to one of two different arms

Study Record Dates

• First Submitted: July 14, 2021
• First Posted: August 9, 2021
• Study Start: November 1, 2021
• Primary Completion: December 31, 2022
• Study Completion: September 30, 2023
• Last Updated: November 28, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)