SMART@Home Feasibility Trial

NCT ID: NCT06159127

Last Updated: 2025-07-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-09

Study Completion Date

2026-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Asthma Asthma in Children

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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SMART@Home

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

Group Type EXPERIMENTAL

SMART@Home

Intervention Type BEHAVIORAL

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

Control

Usual Care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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SMART@Home

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

12 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Children's Hospital Medical Center, Cincinnati

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kevin Hommel, PhD

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital Medical Center, Cincinnati

Rachelle Ramsey, PhD

Role: STUDY_CHAIR

Children's Hospital Medical Center, Cincinnati

Matt Wortman, PhD

Role: STUDY_CHAIR

Children's Hospital Medical Center, Cincinnati

Locations

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Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Kevin Hommel, PhD

Role: CONTACT

513-803-0407

Jessica King, BA

Role: CONTACT

513-803-0920

Facility Contacts

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Kevin, PhD

Role: primary

Other Identifiers

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SMART@Home

Identifier Type: -

Identifier Source: org_study_id

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