Asthma
Conditions
Keywords
asthma
Brief summary
The investigators aim to study the clinical efficacy of a mobile health application, AsthmaCare, and it's impact on long term health outcomes for asthma. AsthmaCare is a novel application developed by members of the study team that was previously studied in a pilot study of 21 children/teenagers 9-16 years old. During the 30 day pilot study, there was universal usage and acceptance by all participants of this novel form of technology and asthma management. This current study aims to measure clinical outcomes for users of the app.
Detailed description
AsthmaCare is a novel mobile health application that integrates personalized asthma reminders with self management feedback. Users input their prescribed daily controller medications and personal asthma triggers upon first loading the app. Reminder messages are pushed through the device at predetermined times to take controller medications. Once daily push notifications are sent to the user regarding tips to avoid preselected asthma triggers. Users are asked to input their use of controller medications, which is entered into a medication log. Every interaction will unlock reward points as gaming theory is integrated into AsthmaCare to maintain user engagement. If symptoms occur or if rescue medication use is logged into AsthmaCare, the user is automatically directed to an interactive asthma self-management plan, aka written asthma treatment plan. When users are in the yellow zone, they receive notifications every 4 hours regarding symptom update or rescue medication use. When users are in the red zone, these notifications occur every 1 hour. When users are in the green zone (baseline, no symptoms), they will receive motivational messages every 24 hours to maintain engagement with the app as well as remind them to continue to use controller medications. In addition to medication reminders and an interactive self-management plan, AsthmaCare provides links to the nearest National Pollen Bureau counting station and allows for symptom/medication diaries to be emailed for sharing with providers or printing. Mobile health applications, particularly for asthma, have not been studies in prospective clinical trials to demonstrate ongoing user engagement or efficacy. This study aims to determine whether users of an asthma mobile health application will have superior clinical outcomes compared with traditional asthma management.
Interventions
OTHERAsthmaCare mobile health application
Personalized, interactive mobile health application designed to send daily medication reminders and assist with self management
OTHERAsthma education
A website with links to written asthma education and videos
Sponsors
David Stukus
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Months to 21 Years
Healthy volunteers
No
Inclusion criteria
* Physician diagnosis of persistent asthma defined by treatment with at least one daily controller medication * Fluent English speaking * Subject must have access to an iOS or Android device in order to download and use the mobile health application * At least one Emergency Department or Urgent Care visit due to asthma exacerbation in the 12 months prior to enrollment
Exclusion criteria
* No prescription/recommendation to use a daily controller medication * Non-English speaking * Lack of access to an iOS or Android device * Current or prior use of AsthmaCare mobile health application at any time. Research assistant will assess by reviewing beforehand a complete list of people who have already downloaded the app
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Emergency Room Visits Secondary to Asthma Exacerbation | 6 months | Number of emergency room visits for asthma 6 months following study enrollment and randomization |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Asthma Exacerbations | 6 months | Number of prednisone courses prescribed for asthma exacerbations during 6 month study time frame |
| Hospitalizations | 6 months | Number of hospitalizations for asthma exacerbation during 6 month study duration |
| Frequency of Use of the Mobile Health Application | 6 months | Analytics from within the mobile application will be measured to determine the frequency and usage patterns of the mobile health application by users during the study period |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| AsthmaCare Intervention Participants randomized to this arm will have the AsthmaCare app downloaded to their mobile device at time of study recruitment. They will have access to AsthmaCare indefinitely after enrollment.
AsthmaCare mobile health application: Personalized, interactive mobile health application designed to send daily medication reminders and assist with self management | 98 |
| Control Group Participants randomized to this arm will receive a link to a website containing asthma education videos and information. They will be able to access this link at their discretion.
Asthma education: A website with links to written asthma education and videos | 95 |
| Total | 193 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 5 | 2 |
Baseline characteristics
| Characteristic | Control Group | AsthmaCare Intervention | Total |
|---|---|---|---|
| Age, Continuous | 6.24 years STANDARD_DEVIATION 4.2 | 7.84 years STANDARD_DEVIATION 5 | 6.80 years STANDARD_DEVIATION 5.4 |
| Controller medications ICS and LABA | 7 Participants | 10 Participants | 17 Participants |
| Controller medications ICS and montelukast | 15 Participants | 17 Participants | 32 Participants |
| Controller medications ICS/LABA and montelukast | 11 Participants | 12 Participants | 23 Participants |
| Controller medications Low dose ICS | 41 Participants | 30 Participants | 71 Participants |
| Controller medications Medium dose ICS | 20 Participants | 28 Participants | 48 Participants |
| Controller medications Montelukast | 1 Participants | 1 Participants | 2 Participants |
| Health Care Utilization for Asthma Exacerbations During 6 Months Prior to Enrollment ED visits | 0.29 visits STANDARD_DEVIATION 0.56 | 0.35 visits STANDARD_DEVIATION 0.56 | 0.32 visits STANDARD_DEVIATION 0.55 |
| Health Care Utilization for Asthma Exacerbations During 6 Months Prior to Enrollment Hospitalizations | 0.2 visits STANDARD_DEVIATION 0.5 | 0.17 visits STANDARD_DEVIATION 0.46 | 0.19 visits STANDARD_DEVIATION 0.48 |
| Health Care Utilization for Asthma Exacerbations During 6 Months Prior to Enrollment Urgent Care visits | 0.26 visits STANDARD_DEVIATION 0.57 | 0.3 visits STANDARD_DEVIATION 0.68 | 0.28 visits STANDARD_DEVIATION 0.62 |
| Insurance Provider Commercial | 1 Participants | 5 Participants | 6 Participants |
| Insurance Provider Medicaid | 93 Participants | 86 Participants | 179 Participants |
| Insurance Provider Self pay | 1 Participants | 7 Participants | 8 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 69 Participants | 77 Participants | 146 Participants |
| Race (NIH/OMB) More than one race | 10 Participants | 7 Participants | 17 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 16 Participants | 14 Participants | 30 Participants |
| Region of Enrollment United States | 95 participants | 98 participants | 193 participants |
| Sex: Female, Male Female | 36 Participants | 44 Participants | 80 Participants |
| Sex: Female, Male Male | 59 Participants | 54 Participants | 113 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 98 | 0 / 95 |
| other Total, other adverse events | 0 / 98 | 0 / 95 |
| serious Total, serious adverse events | 0 / 98 | 0 / 95 |
Outcome results
Primary
Number of Emergency Room Visits Secondary to Asthma Exacerbation
Number of emergency room visits for asthma 6 months following study enrollment and randomization
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| AsthmaCare Intervention | Number of Emergency Room Visits Secondary to Asthma Exacerbation | 0.31 visits | Standard Deviation 0.6 |
| Control Group | Number of Emergency Room Visits Secondary to Asthma Exacerbation | 0.33 visits | Standard Deviation 0.74 |
Secondary
Frequency of Use of the Mobile Health Application
Analytics from within the mobile application will be measured to determine the frequency and usage patterns of the mobile health application by users during the study period
Time frame: 6 months
Population: Data were not collected for this measure
Secondary
Hospitalizations
Number of hospitalizations for asthma exacerbation during 6 month study duration
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| AsthmaCare Intervention | Hospitalizations | 0.14 visits | Standard Deviation 0.38 |
| Control Group | Hospitalizations | 0.1 visits | Standard Deviation 0.33 |
Secondary
Number of Asthma Exacerbations
Number of prednisone courses prescribed for asthma exacerbations during 6 month study time frame
Time frame: 6 months
Population: Data were not collected for this outcome measure