| NCT ID | NCT06159127 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Children's Hospital Medical Center, Cincinnati |
| Condition | Asthma |
| Study Type | INTERVENTIONAL |
| Enrollment | 25 participants |
| Start Date | 2024-09-09 |
| Primary Completion | 2027-04-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
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 25 participants in total. It began in 2024-09-09 with a primary completion date of 2027-04-30.
⚠ 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 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 Criteria
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
Contact & Investigator
Kevin Hommel, PhD
PRINCIPAL INVESTIGATOR
Children's Hospital Medical Center, Cincinnati
Frequently Asked Questions
Who can join the NCT06159127 clinical trial?
This trial is open to participants of all sexes, aged 12 Years or older, up to 18 Years, studying Asthma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06159127 currently recruiting?
Yes, NCT06159127 is actively recruiting participants. Contact the research team at kevin.hommel@cchmc.org for enrollment information.
Where is the NCT06159127 trial being conducted?
This trial is being conducted at Cincinnati, United States.
Who is sponsoring the NCT06159127 clinical trial?
NCT06159127 is sponsored by Children's Hospital Medical Center, Cincinnati. The principal investigator is Kevin Hommel, PhD at Children's Hospital Medical Center, Cincinnati. The trial plans to enroll 25 participants.
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