- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06159127
SMART@Home Feasibility Trial
Self-Management Assistance for Recommended Treatment (SMART)@Home Care
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Kevin Hommel, PhD
- Phone Number: 513-803-0407
- Email: kevin.hommel@cchmc.org
Study Contact Backup
- Name: Jessica King, BA
- Phone Number: 513-803-0920
- Email: jessica.king1@cchmc.org
Study Locations
-
-
Ohio
-
Cincinnati, Ohio, United States, 45229
- Cincinnati Children's Hospital Medical Center
-
Contact:
- Kevin, PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: SMART@Home
Use of the SMART@Home app for medication and symptom tracking
|
Daily medication and diary completion reminders are provided to participants.
Additional educational content regarding self-management skills will be provided.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of days app used
Time Frame: 3 months
|
Number of diaries completed by participant
|
3 months
|
Collaborators and Investigators
Investigators
- 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
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SMART@Home
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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