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NCT06159127 | RECRUITING | Asthma


SMART@Home Feasibility Trial
Sponsor:

Children's Hospital Medical Center, Cincinnati

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.

Condition or disease

Asthma

Asthma in Children

Intervention/treatment

SMART@Home

Phase

NA

Study Type : INTERVENTIONAL
Estimated Enrollment : 25 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : Self-Management Assistance for Recommended Treatment (SMART)@Home Care
Actual Study Start Date : 2024-09-09
Estimated Primary Completion Date : 2024-12-30
Estimated Study Completion Date : 2025-01-01

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 11 Years to 17 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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

SMART@Home Feasibility Trial

Location Details

NCT06159127


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How to Participate

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Locations


RECRUITING

United States, Ohio

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States, 45229

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