SMART@Home Feasibility Trial

Part of paid clinical trials in Cincinnati, Ohio.

Sponsor
Children's Hospital Medical Center, Cincinnati
Study ID
NCT06159127
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
12 Years - 18 Years
Healthy Volunteers
Not accepted

Interventions

  • SMART@Home — BEHAVIORAL
    Daily medication and diary completion reminders are provided to participants. Additional educational content regarding self-management skills will be provided.

Study Details

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.

Key Dates

Start date
Sep 9, 2024
Status verified
Jul 2025
Primary completion
Apr 30, 2026
Completion
Jul 31, 2026

Study Design

Enrollment
25 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: SMART@Home
    Use of the SMART@Home app for medication and symptom tracking, spirometry feedback
  • No Intervention: Control
    Usual Care

Primary Outcome Measure

Medication Adherence [ Time Frame: 6 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Cincinnati Children's Hospital Medical CenterCincinnatiOhio45229
Kevin, PhD

Find similar trials in Cincinnati, OH

By condition
Asthma
By specialty
PulmonologyLung disease
By research site
Cincinnati Children's Hospital Medical Center· Cincinnati, OH

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