Clinical trial NCT03248869: Asthma Mobile Health Application 2.0
Official title: Asthma Mobile Health Application 2.0
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma
Keywords: asthma
mobile application
mobile app
mobile health applications
asthma mobile health application
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
Collaborators: name: Apple Inc.
name: Lifemap Solutions, Inc
name: Sage Bionetworks
First posted: 2017-08-14
Enrollment: 7752
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: DEVICE_FEASIBILITY

Brief summary: 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: 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:

1. Consenting and enrolling a small cohort of subjects with asthma recruited from Mount Sinai pulmonary clinics remotely via downloading the app
2. Feasibility of use of an asthma e-diary and automated e-reminders for medications in this small cohort for one month
3. 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:

1. 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
2. Assess the impact of continued use of an asthma e-diary and automated medication e-reminders for up to 2 years
3. 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
4. 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
5. 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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of downloads
timeFrame: 2 years
measure: Percent of participants who aborted study participation
timeFrame: 2 years
Secondary outcomes:
measure: Frequency of use of the Daily asthma diary
timeFrame: 2 years
measure: Frequency of use of the Asthma Control (AC) questionnaire
timeFrame: 2 years
measure: Frequency of use of the Health Care Utilization (HCU) questionnaire
timeFrame: 2 years
measure: Percent of completion of Daily asthma diary
timeFrame: 2 years
measure: Percent of completion of the Asthma Control (AC) questionnaire
timeFrame: 2 years
measure: Percent of completion of the Health Care Utilization (HCU) questionnaire
timeFrame: 2 years
measure: Frequency of use of optional AMHA features
timeFrame: 2 years
measure: Asthma Control (AC) questionnaire
timeFrame: up to 6 months
measure: EuroQol 5D-5L (EQ-5D-5L)
timeFrame: up to 6 months
measure: Health Care Utilization (HCU) score
timeFrame: up to 6 months
measure: Associations between genetic markers and asthma severity
timeFrame: 2 years
measure: Associations between genetic markers and symptom patterns
timeFrame: 2 years
measure: Associations between genetic markers and medication use/response
timeFrame: 2 years
Other outcomes:
Locations:
city: New York
country: United States
facility: Dept. of Genetics and Genomic Sciences, Icahn Institute for Genomics and Multiscale Biology, Icahn School of Medicine at Mount Sinai
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Yu-feng Y Chan, MD, PhD
role: PRINCIPAL_INVESTIGATOR
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