RecruitingNot ApplicableNCT06159127

SMART@Home Feasibility Trial

Self-Management Assistance for Recommended Treatment (SMART)@Home Care


Sponsor

Children's Hospital Medical Center, Cincinnati

Enrollment

25 participants

Start Date

Sep 9, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 12 YearsMax Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This pilot study is testing a digital health program called SMART@Home to help young people aged 12 to 18 with asthma better manage their condition at home. The study will check whether this technology-based approach is feasible and helpful for patients and their caregivers. **You may be eligible if...** - You are between 12 and 18 years old - You have been diagnosed with asthma and require regular treatment - You and your caregiver are fluent in English **You may NOT be eligible if...** - You or your caregiver have been diagnosed with a pervasive developmental disorder (such as autism) - You are outside the age range of 12 to 18 - You or your caregiver are not English-fluent Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALSMART@Home

Daily medication and diary completion reminders are provided to participants. Additional educational content regarding self-management skills will be provided.


Locations(1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

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NCT06159127


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