Recruiting

Observational Study

Sponsor:

Children's Hospital Medical Center, Cincinnati

Code:

NCT06159127

Conditions

Asthma

Asthma in Children

Eligibility Criteria

Sex: All

Age: 12 - 18

Healthy Volunteers: Not accepted

Interventions

SMART@Home

Study Details

Brief 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.

Conditions

Asthma

Asthma in Children

Study ID

NCT06159127

Start date

Sep 9, 2024

Status verified date

Jul, 2025

Completion date

Jul 31, 2027

Anticipated

Primary completion date

Apr 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 12 - 18

Healthy Volunteers: Not accepted

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 Design

Enrollment

25 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: SMART@Home

Use of the SMART@Home app for medication and symptom tracking, spirometry feedback

no intervention: Control

Usual Care

Interventions

SMART@Home

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

Primary outcome measure

  • Medication Adherence [ Time Frame: 6 months ]
  • Number of days app used [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Locations

Cincinnati Children's Hospital Medical Center

Recruiting

Cincinnati, Ohio, United States, 45229

More Information

Sponsor

Children's Hospital Medical Center, Cincinnati

Last update posted

Jul 2, 2026

Last verified

Jul, 2025

Keywords

  • Asthma

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Children's Hospital Medical Center, Cincinnati on 2026-07-02.