Brief Summary
This project seeks to test and refine an adapted/expanded version of a previously created ASTHMAXcel app.
Brief Title
Adapting and Expanding the Asthma-Educator 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.
Categories
Completion Date
Completion Date Type
Actual
Conditions
Asthma
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
* 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
Inclusion 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
* 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
Gender
All
Gender Based
false
Keywords
Asthma
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Maximum Age
21 Years
Minimum Age
15 Years
NCT Id
NCT03930381
Org Class
Other
Org Full Name
Montefiore Medical Center
Org Study Id
2018-9083
Overall Status
Completed
Phases
Not Applicable
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
Adapting and Expanding the Algorithmic Software Tool to Help Manage Asthma (ASTHMAXcel) for Youth With Asthma
Primary Outcomes
Outcome Description
Asthma symptom burden as measured by the Asthma Control Test
Score Scale: 5 (min = worse); 25 (max = better outcome)
Score Scale: 5 (min = worse); 25 (max = better outcome)
Outcome Measure
Change from Baseline Asthma Control to 3 Month Asthma Control
Outcome Time Frame
Post-Refinement Baseline, 3 Months
Outcome Description
Asthma symptom burden as measured by the Asthma Control Test
Score Scale: 5 (min = worse); 25 (max = better outcome)
Score Scale: 5 (min = worse); 25 (max = better outcome)
Outcome Measure
Change from Baseline Asthma Control to 3 Month Asthma Control
Outcome Time Frame
Post-Refinement Baseline, 4 Months
Secondary Outcomes
Outcome Description
Ability of participants to perceive their asthma symptoms by using the ASTHMAXcel app and a peak flowmeter
Outcome Time Frame
Week 2, Week 4 , Week 6 (Pre and Post Refinement)
Outcome Measure
Asthma Symptom Perception
Outcome Description
Will use the Child Asthma Illness Representation Survey (AIRS) to asses patients knowledge on asthma as well as their attitudes towards their condition.
Score Scale: 4 (min = worse outcome); 20 (max = better outcome)
Score Scale: 4 (min = worse outcome); 20 (max = better outcome)
Outcome Time Frame
Post-Refinement Baseline, 3 Month
Outcome Measure
Asthma Knowledge
Outcome Description
Self-reported adherence by patient using Medication Adherence Report Scale
Score Scale: 10 (min = worse outcome); 50 (max = better outcome)
Score Scale: 10 (min = worse outcome); 50 (max = better outcome)
Outcome Time Frame
Post-Refinement Baseline, 3 Month
Outcome Measure
Medication Adherence
Outcome Description
Quality of life of participants, measured by mini-Asthma Quality of Life Questionnaire
Score Scale: 15 (min = worse outcome); 105 (max = better outcome)
Score Scale: 15 (min = worse outcome); 105 (max = better outcome)
Outcome Time Frame
Post-Refinement Baseline, 3 Month
Outcome Measure
Asthma Quality of Life
Outcome Description
Self-Reported Emergency Department (ED) visits
Outcome Time Frame
Post-Refinement Baseline, 3 Month
Outcome Measure
Emergency Department Visits
Outcome Description
Patient satisfaction with study measured by the Client Satisfaction Questionnaire-8
Score Scale: 8 (min = worse outcome); 32 (max = better outcome)
Score Scale: 8 (min = worse outcome); 32 (max = better outcome)
Outcome Time Frame
Post-Refinement Baseline, 3 Month
Outcome Measure
Patient Satisfaction
Outcome Description
Patient satisfaction with ASTHMAXcel app interface measured by Questionnaire for User Interface Survey (QUIS)
Score Scale: 0 (min = worse outcome); 261 (max = better outcome)
Answers scale from 0 (terrible/hard to understand)) to 9 (wonderful/easy to understand)
Score Scale: 0 (min = worse outcome); 261 (max = better outcome)
Answers scale from 0 (terrible/hard to understand)) to 9 (wonderful/easy to understand)
Outcome Time Frame
Post-Refinement Baseline, 3 Month
Outcome Measure
Patient Interface Satisfaction
Outcome Description
Time spent on app and different screens of app, measured using Google Analytics
Outcome Time Frame
Baseline, 3 Month
Outcome Measure
Patient Usage
Outcome Description
Ability for patients to comprehend Newest Vital Sign screening tool
Outcome Time Frame
Post-Refinement Baseline
Outcome Measure
Health Literacy
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Child
Adult
Maximum Age Number (converted to Years and rounded down)
21
Minimum Age Number (converted to Years and rounded down)
15
Investigators
Investigator Type
Principal Investigator
Investigator Name
Sunit Jariwala
Investigator Email
sjariwal@montefiore.org