Asthma Mobile Health Application 2.0

Study Overview
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Brief Summary
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Mobile health applications (MHA) are increasingly being explored as tools to assist in management of chronic diseases. Little is known regarding which characteristics of MHAs are effective and there is limited data suggesting a real-world impact on health outcomes. Asthma is one of the most common and costly of the chronic diseases, impacting a broad range of the population including both children and adults. It is a variable disease necessitating regular medication use, monitoring of symptoms, and avoidance of specific triggers. These characteristics of asthma make it a chronic disease that is particularly amenable to having an MHA facilitate active monitoring outside of periodic traditional medical visits. The study team has designed a MHA focused on asthma subjects to test the feasibility of an asthma mobile health application (AMHA). The AMHA 2.0 study is the result of a collaboration between MHA developers and Mount Sinai faculty with expertise in the fields of asthma, research design, data storage, and data analysis. AMHA 2.0 incorporated elements of usual clinical care (that may take place during typical office visits), such as medication reminders, a daily asthma diary to track asthma control (AC) and medication use, patient education and assessments of quality of life (QoL), and health care utilization (HCU).

Detailed Description
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Mobile health applications (MHA) are increasingly being explored as tools to assist in management of chronic diseases. Little is known regarding which characteristics of MHAs are effective and there is limited data suggesting a real-world impact on health outcomes. Asthma is one of the most common and costly of the chronic diseases, impacting a broad range of the population including both children and adults. It is a variable disease necessitating regular medication use, monitoring of symptoms, and avoidance of specific triggers. These characteristics of asthma make it a chronic disease that is particularly amenable to having an MHA facilitate active monitoring outside of periodic traditional medical visits. The study team has designed a MHA focused on asthma subjects to test the feasibility of an asthma mobile health application (AMHA). The AMHA 2.0 study is the result of a collaboration between MHA developers and Mount Sinai faculty with expertise in the fields of asthma, research design, data storage, and data analysis. AMHA 2.0 incorporated elements of usual clinical care (that may take place during typical office visits), such as medication reminders, a daily asthma diary to track asthma control (AC) and medication use, patient education and assessments of quality of life (QoL), and health care utilization (HCU). During the AMHA 2.0 study, the aims are to evaluate the feasibility of: Consenting and enrolling a small cohort of subjects with asthma recruited from Mount Sinai pulmonary clinics remotely via downloading the app Feasibility of use of an asthma e-diary and automated e-reminders for medications in this small cohort for one month Exploring if a small cohort of participants will share data from wearable health and fitness monitoring devices if they own and use such devices. The primary enrollment period for AMHA 2.0 was met in September 2015. More than 7,000 individuals e-consented for the AMHA 2.0 study, providing more than 80,000 survey responses with many participants granting AMHA 2.0 investigators access to geo-location and wellness data. Data collected during the first six months of the AMHA 2.0 study has provided evidence to answer all primary outcome measures. Continuation of the AMHA 2.0 protocol was approved in December 2015, expanding the study to a larger population who will be followed for a more extended period of time and will be recruited via availability of the AMHA in the Apple App Store in the US, UK, and Ireland. The latest modification submitted in January, adds an entirely new aim, OM6 and SA6, to the project to include a genetics module. The objectives for the continuation study are: To determine the feasibility of recruiting, consenting and enrolling a larger number of subjects remotely via the Apple App Store without direct participant contact during any phase of the study Assess the impact of continued use of an asthma e-diary and automated medication e-reminders for up to 2 years Explore the feasibility of sharing of data from wearable health and fitness monitoring devices (if applicable) from a larger cohort of patients for up to 2 years To test the medical accuracy of algorithms that may be used in future app versions to give specific feedback to participants based on information they input into the AMHA To investigate the association between DNA variants and asthma phenotypes including: asthma severity, symptom patterns, and medication use/response This second phase of research is designed to continue the process of developing an AMHA that facilitates asthma self-monitoring, promotes positive behavioral changes, and reinforces adherence to treatment plans according to current asthma guidelines, all in a user-friendly fashion conducive to long term use.

Official Title
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Asthma Mobile Health Application 2.0

Conditions
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Asthma

Intervention / Treatment
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* Other: Current Daily Survey
* Other: Mobile Health App


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years of age or older Self-reported physician diagnosed asthma Have an iPhone Sufficient English-language ability to participate in informed consent process, complete study assessments and understand the text in mobile phone-delivered interventions Exclusion Criteria: <18 years of age Not currently taking any asthma medications Does not own an iPhone or know how to handle a mobile phone Are unable to read or understand the study materials Current pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Device Feasibility
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A/B testing is a randomized statistical experiment with intervention and control study arms, A and B. New users, as of December 2015, will be stratified and randomized to different daily survey formats in order to test differences in daily survey participation rates. Since this was a mobile app based study, a first of its kind - which was available in the App store, it was possible to recruit widely in large numbers. Therefore, even though this was a feasibility study, the sample size was large.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Current Daily Survey<br>need description | Other: Current Daily Survey<br>* need description<br>|
| Experimental: Mobile Health App (MHA)<br>Participants download the mobile health app via the Apple App Store | Other: Mobile Health App<br>* Participants recruited, consented and enrolled via the AMHA and complete assessments using the app<br>* Other names: Asthma Mobile Health App;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of downloads | Number of people who downloaded AMHA | 2 years | 
| Percent of participants who aborted study participation | Percent of aborted study participants before completion inclusion/exclusion criteria | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of use of the Daily asthma diary | Feasibility and implied participant acceptability by counting frequency of use of app | 2 years | 
| Frequency of use of the Asthma Control (AC) questionnaire | Feasibility and implied participant acceptability by counting frequency of use of app | 2 years | 
| Frequency of use of the Health Care Utilization (HCU) questionnaire | Feasibility and implied participant acceptability by counting frequency of use of app | 2 years | 
| Percent of completion of Daily asthma diary | Feasibility and implied participant acceptability by counting percent of completion of features in AMHA | 2 years | 
| Percent of completion of the Asthma Control (AC) questionnaire | Feasibility and implied participant acceptability by counting percent of completion of features in AMHA | 2 years | 
| Percent of completion of the Health Care Utilization (HCU) questionnaire | Feasibility and implied participant acceptability by counting percent of completion of features in AMHA | 2 years | 
| Frequency of use of optional AMHA features | Feasibility and implied participant acceptability by frequency of use of optional AMHA features | 2 years | 
| Asthma Control (AC) questionnaire | Daily asthma diary to track asthma control. AC is based o modified GOAL criteria. Total scale range is from 0 (no impairment) 6 (maximal impairment for symptoms and rescue use) | up to 6 months | 
| EuroQol 5D-5L (EQ-5D-5L) | EuroQol 5D-5L used to measure quality of life: 5 items are scored from 1 (no problems) to 5 (extreme severe problems). The numerals 1-5 have no arithmetic properties and should not be used as a cardinal scale. total of 3125 possible health states is defined in this way. Each state is referred to in terms of a 5 digit code. For example, state 11111 indicates no problems on any of the 5 dimensions, while state 55555 indicates severe problems in each item. | up to 6 months | 
| Health Care Utilization (HCU) score | Questionnaire regarding HCU events with scores from 0 (no health services used to 10 (all health care service options utilized). | up to 6 months | 
| Associations between genetic markers and asthma severity | Statistically significant associations between DNA variants and asthma severity. Clustering, regression, and ensemble statistical models will be employed to partition AMHA 2.0 participants into distinct phenotypic classes. | 2 years | 
| Associations between genetic markers and symptom patterns | Statistically significant associations between DNA variants and symptom patterns. Clustering, regression, and ensemble statistical models will be employed to partition AMHA 2.0 participants into distinct phenotypic classes. | 2 years | 
| Associations between genetic markers and medication use/response | Statistically significant associations between DNA variants and medication use/response. Clustering, regression, and ensemble statistical models will be employed to partition AMHA 2.0 participants into distinct phenotypic classes. | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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asthma, mobile application, mobile app, mobile health applications, asthma mobile health application