Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229, United States
Location status: Recruiting
Location contact
Kevin, PhD
CONTACT
NCT Number: NCT06159127
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.
Interested in participating?
Request Info12 year–18 year
All sexes
Interventional
Not applicable
Cincinnati, Ohio, 45229, United States
Location status: Recruiting
Kevin, PhD
CONTACT
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Daily medication and diary completion reminders are provided to participants. Additional educational content regarding self-management skills will be provided.
Time frame: 6 months
Monthly adherence will be calculated by comparing doses taken to doses recommended by IMAAP. Participants will also report rescue medication use each month when completing the ACT.
Time frame: 6 months
Number of diaries completed by participant
Contact information is provided by the study sponsor or research team.
Jessica King, BA
CONTACT
Kevin Hommel, PhD
CONTACT
Children's Hospital Medical Center, Cincinnati
Other
Self-Management Assistance for Recommended Treatment (SMART)@Home Care
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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