SMART@Home Feasibility Trial
Self-Management Assistance for Recommended Treatment (SMART)@Home Care
1 other identifier
interventional
25
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable asthma
Started Sep 2024
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 28, 2023
CompletedFirst Posted
Study publicly available on registry
December 6, 2023
CompletedStudy Start
First participant enrolled
September 9, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
July 31, 2026
ExpectedJuly 11, 2025
July 1, 2025
1.6 years
November 28, 2023
July 8, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Medication Adherence
Monthly adherence will be calculated by comparing doses taken to doses recommended by IMAAP. Participants will also report rescue medication use each month when completing the ACT.
6 months
Number of days app used
Number of diaries completed by participant
6 months
Study Arms (2)
SMART@Home
EXPERIMENTALUse of the SMART@Home app for medication and symptom tracking, spirometry feedback
Control
NO INTERVENTIONUsual Care
Interventions
Daily medication and diary completion reminders are provided to participants. Additional educational content regarding self-management skills will be provided.
Eligibility Criteria
You may qualify if:
- Patients diagnosed with a chronic medical condition requiring regular treatment, i.e., asthma
- Ages 12-18
- English fluency for patient and caregiver
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kevin Hommel, PhD
Children's Hospital Medical Center, Cincinnati
- STUDY CHAIR
Rachelle Ramsey, PhD
Children's Hospital Medical Center, Cincinnati
- STUDY CHAIR
Matt Wortman, PhD
Children's Hospital Medical Center, Cincinnati
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 28, 2023
First Posted
December 6, 2023
Study Start
September 9, 2024
Primary Completion
April 30, 2026
Study Completion (Estimated)
July 31, 2026
Last Updated
July 11, 2025
Record last verified: 2025-07