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SMART@Home Feasibility Trial

RECRUITINGN/ASponsored by Children's Hospital Medical Center, Cincinnati
Actively Recruiting
PhaseN/A
SponsorChildren's Hospital Medical Center, Cincinnati
Started2024-09-09
Est. completion2026-04-30
Eligibility
Age12 Years – 18 Years
Healthy vol.Accepted
Locations1 site
View on ClinicalTrials.gov →

NCT06159127

Summary

The proposed research addresses the limitations or lack of a digital platform to provide remote care of medically complex patients. Previous attempts have had poor clinical validity and suffered lack of patient engagement. The study team will deconstruct the previously implemented SMART platforms to create a roadmap, platform, and template to guide clinicians to create new tools. 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.

Eligibility

Age: 12 Years – 18 YearsHealthy volunteers accepted
Inclusion Criteria:

* Patients diagnosed with a chronic medical condition requiring regular treatment, i.e., asthma
* Ages 12-18
* English fluency for patient and caregiver

Exclusion Criteria:

* Diagnosis of pervasive developmental disorder in patient or caregiver as determined by medical chart review
* Diagnosis of serious mental illness (e.g., schizophrenia) in patient or caregiver as determined by medical chart review

Conditions2

AsthmaAsthma in Children

Locations1 site

Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
Kevin, PhD

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