Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
25 participants
INTERVENTIONAL
2024-09-09
2026-07-31
Brief Summary
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Results from Phase 1 of this project highlighted the need for connectivity between the SMART@Home app and Bluetooth-enable devices to provide objective disease activity data as well as integration with Epic electronic health record so that providers can use the data to inform treatment planning and decision making. A subsequent pilot user validation trial is also needed to confirm development goals were met. Conducting a pilot user validation trial of the SMART@Home asthma tracker, spirometer, and action plan is the purpose of the next phases of this study.
A beta test the SMART@Home Asthma Tracker and asthma action plan algorithm will take place with approximately 8 participants. Beta testing will have participants record simulated increases in symptoms to ensure appropriate levels of care is communicated via the app. Then, a group of 40 adolescent (ages 12-17) patients with asthma for a 6-month pilot Randomized Control Trial (RCT). Participants will be randomized into either the IMAAP SMART@Home (n=20) or control (n=20) groups following the completion of baseline measures to test the interactive asthma action plan functionality and impact.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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SMART@Home
Use of the SMART@Home app for medication and symptom tracking, spirometry feedback
SMART@Home
Daily medication and diary completion reminders are provided to participants. Additional educational content regarding self-management skills will be provided.
Control
Usual Care
No interventions assigned to this group
Interventions
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SMART@Home
Daily medication and diary completion reminders are provided to participants. Additional educational content regarding self-management skills will be provided.
Eligibility Criteria
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Inclusion Criteria
* Ages 12-18
* English fluency for patient and caregiver
Exclusion Criteria
* Diagnosis of serious mental illness (e.g., schizophrenia) in patient or caregiver as determined by medical chart review
12 Years
18 Years
ALL
No
Sponsors
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Children's Hospital Medical Center, Cincinnati
OTHER
Responsible Party
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Principal Investigators
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Kevin Hommel, PhD
Role: PRINCIPAL_INVESTIGATOR
Children's Hospital Medical Center, Cincinnati
Rachelle Ramsey, PhD
Role: STUDY_CHAIR
Children's Hospital Medical Center, Cincinnati
Matt Wortman, PhD
Role: STUDY_CHAIR
Children's Hospital Medical Center, Cincinnati
Locations
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Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Countries
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Central Contacts
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Facility Contacts
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Kevin, PhD
Role: primary
Other Identifiers
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SMART@Home
Identifier Type: -
Identifier Source: org_study_id
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