NCT06159127Recruiting
SMART@Home Feasibility Trial
Self-Management Assistance for Recommended Treatment (SMART)@Home Care
Source: ClinicalTrials.gov · Last updated 6 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 25 (estimated)
- First submitted
- 28 Nov 2023
- Start date
- 9 Sept 2024
- Primary completion date
- 30 Apr 2027
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Diseases
- Asthma
- NCT number
- NCT06159127
What you commit to
- Study type: Interventional
- Planned participants: 25
- From 9 Sept 2024 to the primary completion date, 30 Apr 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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
Who the study is looking for
- Patients diagnosed with a chronic medical condition requiring regular treatment, i.e., asthma
- Ages 12-18
- English fluency for patient and caregiver
Age in the registry: 12 years to 18 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Cincinnati Children's Hospital Medical Center Coordinator of this site? Confirm its status | Cincinnati | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.