Adapting and Expanding the Algorithmic Software Tool to Help Manage Asthma (ASTHMAXcel) for Youth With Asthma
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Montefiore Medical Center
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Change from Baseline Asthma Control to 3 Month Asthma Control
Study Overview
Brief Summary
This project seeks to test and refine an adapted/expanded version of a previously created ASTHMAXcel app.
Detailed Description
The study will test the adapted app on participants ages 15-21 (recruited from outpatient primary and specialty care sites at Montefiore) with asthma, for a period of 4 and a half months, and will conduct formative and summative evaluation of the application's functionality and usability. The investigators will also be collecting process and clinical outcomes.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 15 Years to 21 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •English-speaking individuals between 15-21
- •Persistent asthma (diagnosis made by a healthcare provider)
- •On a daily controller medication
- •Able to give informed consent
- •Smartphone (iOS or Android) access
Exclusion Criteria
- •Use of oral corticosteroids in the 2 weeks prior to the baseline visit
- •Pregnancy
- •Severe psychiatric or cognitive problems that would prohibit an individual from understanding and completing the protocol
- •Patients that previously received the ASTHMA-Educator application
Arms & Interventions
Intervention Arm
This group will download the ASTHMAXcel application and use it for the duration of the study
Intervention: ASTHMAXcel App (Other)
Usual Care Arm
This group will just receive normal provider care
Outcomes
Primary Outcomes
Change from Baseline Asthma Control to 3 Month Asthma Control
Time Frame: Post-Refinement Baseline, 4 Months
Asthma symptom burden as measured by the Asthma Control Test Score Scale: 5 (min = worse); 25 (max = better outcome)
Change from Baseline Asthma Control to 3 Month Asthma Control
Time Frame: Post-Refinement Baseline, 3 Months
Asthma symptom burden as measured by the Asthma Control Test Score Scale: 5 (min = worse); 25 (max = better outcome)
Secondary Outcomes
- Medication Adherence(Post-Refinement Baseline, 3 Month)
- Asthma Symptom Perception(Week 2, Week 4 , Week 6 (Pre and Post Refinement))
- Patient Satisfaction(Post-Refinement Baseline, 3 Month)
- Emergency Department Visits(Post-Refinement Baseline, 3 Month)
- Asthma Quality of Life(Post-Refinement Baseline, 3 Month)
- Patient Interface Satisfaction(Post-Refinement Baseline, 3 Month)
- Patient Usage(Baseline, 3 Month)
- Health Literacy(Post-Refinement Baseline)
- Asthma Knowledge(Post-Refinement Baseline, 3 Month)