Clinical trial NCT03930381: Adapting and Expanding the Asthma-Educator App
Official title: Adapting and Expanding the Algorithmic Software Tool to Help Manage Asthma (ASTHMAXcel) for Youth With Asthma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma
Keywords: Asthma
Lead sponsor: Montefiore Medical Center
Sponsor class: OTHER
First posted: 2019-04-29
Enrollment: 80
Sex: ALL
Minimum age (years): 15
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Study will eventually compare health outcomes between a group given the ASTHMAXcel intervention and a group given Usual Care
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change from Baseline Asthma Control to 3 Month Asthma Control
timeFrame: Post-Refinement Baseline, 3 Months
measure: Change from Baseline Asthma Control to 3 Month Asthma Control
timeFrame: Post-Refinement Baseline, 4 Months
Secondary outcomes:
measure: Asthma Symptom Perception
timeFrame: Week 2, Week 4 , Week 6 (Pre and Post Refinement)
measure: Asthma Knowledge
timeFrame: Post-Refinement Baseline, 3 Month
measure: Medication Adherence
timeFrame: Post-Refinement Baseline, 3 Month
measure: Asthma Quality of Life
timeFrame: Post-Refinement Baseline, 3 Month
measure: Emergency Department Visits
timeFrame: Post-Refinement Baseline, 3 Month
measure: Patient Satisfaction
timeFrame: Post-Refinement Baseline, 3 Month
measure: Patient Interface Satisfaction
timeFrame: Post-Refinement Baseline, 3 Month
measure: Patient Usage
timeFrame: Baseline, 3 Month
measure: Health Literacy
timeFrame: Post-Refinement Baseline
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
Study officials:
affiliation: Montefiore Medical Center
name: Sunit Jariwala, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chan A, De Simoni A, Wileman V, Holliday L, Newby CJ, Chisari C, Ali S, Zhu N, Padakanti P, Pinprachanan V, Ting V, Griffiths CJ. Digital interventions to improve adherence to maintenance medication in asthma. Cochrane Database Syst Rev. 2022 Jun 13;6(6):CD013030. doi: 10.1002/14651858.CD013030.pub2.