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SMART@Home Feasibility Trial

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
12 Years to 18 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests the SMART@Home app, a breathing test device, and an asthma care plan to help teens manage asthma at home. A small group will first test the app with made-up symptom changes. Then, 40 teens ages 12–17 with asthma will be placed by chance into an app group or a comparison group for 6 months.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have a long-term health condition, such as asthma, that needs regular treatment.
  • Be ages 12–18. The 6-month asthma trial describes enrolling ages 12–17.
  • Both the patient and caregiver must speak English fluently.

Who can't join

  • The patient or caregiver has a pervasive developmental disorder—a condition that affects social and communication skills—listed in their medical record.
  • The patient or caregiver has a serious mental illness, such as schizophrenia, listed in their medical record.

Simplified for readability. The official criteria below are what the study team uses.

Official 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

Study sites (1)

OH