Asthma, Asthma in Children
Conditions
Keywords
Asthma
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.
Interventions
BEHAVIORALSMART@Home
Daily medication and diary completion reminders are provided to participants. Additional educational content regarding self-management skills will be provided.
Sponsors
Children's Hospital Medical Center, Cincinnati
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
12 Years to 18 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Medication Adherence | 6 months | 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. |
| Number of days app used | 6 months | Number of diaries completed by participant |
Countries
United States
Contacts
CONTACTKevin Hommel, PhD
CONTACTJessica King, BA
PRINCIPAL_INVESTIGATORKevin Hommel, PhD
Children's Hospital Medical Center, Cincinnati
STUDY_CHAIRRachelle Ramsey, PhD
Children's Hospital Medical Center, Cincinnati
STUDY_CHAIRMatt Wortman, PhD
Children's Hospital Medical Center, Cincinnati
Outcome results
None listed