Asthma Clinical Trial
Official title:
Self-Management Assistance for Recommended Treatment (SMART)@Home Care
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.
| Status | Not yet recruiting |
| Enrollment | 25 |
| Est. completion date | January 1, 2025 |
| Est. primary completion date | December 30, 2024 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 11 Years to 17 Years |
| Eligibility | Inclusion Criteria: - Patients diagnosed with a chronic medical condition requiring regular treatment, i.e., asthma - Ages 11-17 - 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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio |
| Lead Sponsor | Collaborator |
|---|---|
| Children's Hospital Medical Center, Cincinnati |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Number of days app used | Number of diaries completed by participant | 3 months |
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