SMART@Home Feasibility Trial
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: SMART@Home.
- Who it may be relevant to
- Registry conditions: Asthma, Asthma in Children. Basic parameters: 12 years — 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Self-Management Assistance for Recommended Treatment (SMART)@Home Care
Overview
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.
Interventions
- Behavioral SMART@Home
Daily medication and diary completion reminders are provided to participants. Additional educational content regarding self-management skills will be provided.
Primary outcome measures
- Medication Adherence [Time frame: 6 months]
- Number of days app used [Time frame: 6 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Cincinnati Children's Hospital Medical Center — Cincinnati
Identifiers
NCT: NCT06159127 · SMART@Home