<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03248869</url>
  </required_header>
  <id_info>
    <org_study_id>GCO 15-0063</org_study_id>
    <nct_id>NCT03248869</nct_id>
  </id_info>
  <brief_title>Asthma Mobile Health Application 2.0</brief_title>
  <official_title>Asthma Mobile Health Application 2.0</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Icahn School of Medicine at Mount Sinai</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Apple Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Lifemap Solutions, Inc</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Sage Bionetworks</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Icahn School of Medicine at Mount Sinai</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Mobile health applications (MHA) are increasingly being explored as tools to assist in&#xD;
      management of chronic diseases. Little is known regarding which characteristics of MHAs are&#xD;
      effective and there is limited data suggesting a real-world impact on health outcomes. Asthma&#xD;
      is one of the most common and costly of the chronic diseases, impacting a broad range of the&#xD;
      population including both children and adults. It is a variable disease necessitating regular&#xD;
      medication use, monitoring of symptoms, and avoidance of specific triggers. These&#xD;
      characteristics of asthma make it a chronic disease that is particularly amenable to having&#xD;
      an MHA facilitate active monitoring outside of periodic traditional medical visits. The study&#xD;
      team has designed a MHA focused on asthma subjects to test the feasibility of an asthma&#xD;
      mobile health application (AMHA). The AMHA 2.0 study is the result of a collaboration between&#xD;
      MHA developers and Mount Sinai faculty with expertise in the fields of asthma, research&#xD;
      design, data storage, and data analysis. AMHA 2.0 incorporated elements of usual clinical&#xD;
      care (that may take place during typical office visits), such as medication reminders, a&#xD;
      daily asthma diary to track asthma control (AC) and medication use, patient education and&#xD;
      assessments of quality of life (QoL), and health care utilization (HCU).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Mobile health applications (MHA) are increasingly being explored as tools to assist in&#xD;
      management of chronic diseases. Little is known regarding which characteristics of MHAs are&#xD;
      effective and there is limited data suggesting a real-world impact on health outcomes. Asthma&#xD;
      is one of the most common and costly of the chronic diseases, impacting a broad range of the&#xD;
      population including both children and adults. It is a variable disease necessitating regular&#xD;
      medication use, monitoring of symptoms, and avoidance of specific triggers. These&#xD;
      characteristics of asthma make it a chronic disease that is particularly amenable to having&#xD;
      an MHA facilitate active monitoring outside of periodic traditional medical visits. The study&#xD;
      team has designed a MHA focused on asthma subjects to test the feasibility of an asthma&#xD;
      mobile health application (AMHA). The AMHA 2.0 study is the result of a collaboration between&#xD;
      MHA developers and Mount Sinai faculty with expertise in the fields of asthma, research&#xD;
      design, data storage, and data analysis. AMHA 2.0 incorporated elements of usual clinical&#xD;
      care (that may take place during typical office visits), such as medication reminders, a&#xD;
      daily asthma diary to track asthma control (AC) and medication use, patient education and&#xD;
      assessments of quality of life (QoL), and health care utilization (HCU).&#xD;
&#xD;
      During the AMHA 2.0 study, the aims are to evaluate the feasibility of:&#xD;
&#xD;
        1. Consenting and enrolling a small cohort of subjects with asthma recruited from Mount&#xD;
           Sinai pulmonary clinics remotely via downloading the app&#xD;
&#xD;
        2. Feasibility of use of an asthma e-diary and automated e-reminders for medications in&#xD;
           this small cohort for one month&#xD;
&#xD;
        3. Exploring if a small cohort of participants will share data from wearable health and&#xD;
           fitness monitoring devices if they own and use such devices.&#xD;
&#xD;
      The primary enrollment period for AMHA 2.0 was met in September 2015. More than 7,000&#xD;
      individuals e-consented for the AMHA 2.0 study, providing more than 80,000 survey responses&#xD;
      with many participants granting AMHA 2.0 investigators access to geo-location and wellness&#xD;
      data. Data collected during the first six months of the AMHA 2.0 study has provided evidence&#xD;
      to answer all primary outcome measures.&#xD;
&#xD;
      Continuation of the AMHA 2.0 protocol was approved in December 2015, expanding the study to a&#xD;
      larger population who will be followed for a more extended period of time and will be&#xD;
      recruited via availability of the AMHA in the Apple App Store in the US, UK, and Ireland. The&#xD;
      latest modification submitted in January, adds an entirely new aim, OM6 and SA6, to the&#xD;
      project to include a genetics module. The objectives for the continuation study are:&#xD;
&#xD;
        1. To determine the feasibility of recruiting, consenting and enrolling a larger number of&#xD;
           subjects remotely via the Apple App Store without direct participant contact during any&#xD;
           phase of the study&#xD;
&#xD;
        2. Assess the impact of continued use of an asthma e-diary and automated medication&#xD;
           e-reminders for up to 2 years&#xD;
&#xD;
        3. Explore the feasibility of sharing of data from wearable health and fitness monitoring&#xD;
           devices (if applicable) from a larger cohort of patients for up to 2 years&#xD;
&#xD;
        4. To test the medical accuracy of algorithms that may be used in future app versions to&#xD;
           give specific feedback to participants based on information they input into the AMHA&#xD;
&#xD;
        5. To investigate the association between DNA variants and asthma phenotypes including:&#xD;
           asthma severity, symptom patterns, and medication use/response&#xD;
&#xD;
      This second phase of research is designed to continue the process of developing an AMHA that&#xD;
      facilitates asthma self-monitoring, promotes positive behavioral changes, and reinforces&#xD;
      adherence to treatment plans according to current asthma guidelines, all in a user-friendly&#xD;
      fashion conducive to long term use.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 15, 2015</start_date>
  <completion_date type="Actual">March 15, 2017</completion_date>
  <primary_completion_date type="Actual">March 15, 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <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 &quot;app&quot; 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.</intervention_model_description>
    <primary_purpose>Device Feasibility</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of downloads</measure>
    <time_frame>2 years</time_frame>
    <description>Number of people who downloaded AMHA</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percent of participants who aborted study participation</measure>
    <time_frame>2 years</time_frame>
    <description>Percent of aborted study participants before completion inclusion/exclusion criteria</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Frequency of use of the Daily asthma diary</measure>
    <time_frame>2 years</time_frame>
    <description>Feasibility and implied participant acceptability by counting frequency of use of app</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequency of use of the Asthma Control (AC) questionnaire</measure>
    <time_frame>2 years</time_frame>
    <description>Feasibility and implied participant acceptability by counting frequency of use of app</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequency of use of the Health Care Utilization (HCU) questionnaire</measure>
    <time_frame>2 years</time_frame>
    <description>Feasibility and implied participant acceptability by counting frequency of use of app</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent of completion of Daily asthma diary</measure>
    <time_frame>2 years</time_frame>
    <description>Feasibility and implied participant acceptability by counting percent of completion of features in AMHA</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent of completion of the Asthma Control (AC) questionnaire</measure>
    <time_frame>2 years</time_frame>
    <description>Feasibility and implied participant acceptability by counting percent of completion of features in AMHA</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent of completion of the Health Care Utilization (HCU) questionnaire</measure>
    <time_frame>2 years</time_frame>
    <description>Feasibility and implied participant acceptability by counting percent of completion of features in AMHA</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequency of use of optional AMHA features</measure>
    <time_frame>2 years</time_frame>
    <description>Feasibility and implied participant acceptability by frequency of use of optional AMHA features</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Asthma Control (AC) questionnaire</measure>
    <time_frame>up to 6 months</time_frame>
    <description>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)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>EuroQol 5D-5L (EQ-5D-5L)</measure>
    <time_frame>up to 6 months</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health Care Utilization (HCU) score</measure>
    <time_frame>up to 6 months</time_frame>
    <description>Questionnaire regarding HCU events with scores from 0 (no health services used to 10 (all health care service options utilized).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Associations between genetic markers and asthma severity</measure>
    <time_frame>2 years</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Associations between genetic markers and symptom patterns</measure>
    <time_frame>2 years</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Associations between genetic markers and medication use/response</measure>
    <time_frame>2 years</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">7752</enrollment>
  <condition>Asthma</condition>
  <arm_group>
    <arm_group_label>Current Daily Survey</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>need description</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Mobile Health App (MHA)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants download the mobile health app via the Apple App Store</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Current Daily Survey</intervention_name>
    <description>need description</description>
    <arm_group_label>Current Daily Survey</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Mobile Health App</intervention_name>
    <description>Participants recruited, consented and enrolled via the AMHA and complete assessments using the app</description>
    <arm_group_label>Mobile Health App (MHA)</arm_group_label>
    <other_name>Asthma Mobile Health App</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18 years of age or older&#xD;
&#xD;
          -  Self-reported physician diagnosed asthma&#xD;
&#xD;
          -  Have an iPhone&#xD;
&#xD;
          -  Sufficient English-language ability to participate in informed consent process,&#xD;
             complete study assessments and understand the text in mobile phone-delivered&#xD;
             interventions&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  &lt;18 years of age&#xD;
&#xD;
          -  Not currently taking any asthma medications&#xD;
&#xD;
          -  Does not own an iPhone or know how to handle a mobile phone&#xD;
&#xD;
          -  Are unable to read or understand the study materials&#xD;
&#xD;
          -  Current pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yu-feng Y Chan, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Icahn School of Medicine at Mount Sinai</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Dept. of Genetics and Genomic Sciences, Icahn Institute for Genomics and Multiscale Biology, Icahn School of Medicine at Mount Sinai</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10029</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://www.cdc.gov/vitalsigns/</url>
    <description>CDC Vital Signs May 2011, accessed 9/13/14</description>
  </link>
  <link>
    <url>http://ginasthma.org</url>
    <description>Global Strategy for Asthma Management and Prevention, Global Initiative for Asthma (GINA) 2014.</description>
  </link>
  <reference>
    <citation>Murphy KR, Meltzer EO, Blaiss MS, Nathan RA, Stoloff SW, Doherty DE. Asthma management and control in the United States: results of the 2009 Asthma Insight and Management survey. Allergy Asthma Proc. 2012 Jan-Feb;33(1):54-64. doi: 10.2500/aap.2011.32.3518. Epub 2011 Dec 15.</citation>
    <PMID>22309716</PMID>
  </reference>
  <reference>
    <citation>Demoly P, Annunziata K, Gubba E, Adamek L. Repeated cross-sectional survey of patient-reported asthma control in Europe in the past 5 years. Eur Respir Rev. 2012 Mar 1;21(123):66-74. doi: 10.1183/09059180.00008111.</citation>
    <PMID>22379176</PMID>
  </reference>
  <reference>
    <citation>Eakin MN, Rand CS. Improving patient adherence with asthma self-management practices: what works? Ann Allergy Asthma Immunol. 2012 Aug;109(2):90-2. doi: 10.1016/j.anai.2012.06.009. No abstract available.</citation>
    <PMID>22840247</PMID>
  </reference>
  <reference>
    <citation>Tran N, Coffman JM, Sumino K, Cabana MD. Patient reminder systems and asthma medication adherence: a systematic review. J Asthma. 2014 Jun;51(5):536-43. doi: 10.3109/02770903.2014.888572. Epub 2014 Feb 13.</citation>
    <PMID>24506699</PMID>
  </reference>
  <reference>
    <citation>Foster JM, Usherwood T, Smith L, Sawyer SM, Xuan W, Rand CS, Reddel HK. Inhaler reminders improve adherence with controller treatment in primary care patients with asthma. J Allergy Clin Immunol. 2014 Dec;134(6):1260-1268.e3. doi: 10.1016/j.jaci.2014.05.041. Epub 2014 Jul 22.</citation>
    <PMID>25062783</PMID>
  </reference>
  <reference>
    <citation>Marcano Belisario JS, Huckvale K, Greenfield G, Car J, Gunn LH. Smartphone and tablet self management apps for asthma. Cochrane Database Syst Rev. 2013 Nov 27;2013(11):CD010013. doi: 10.1002/14651858.CD010013.pub2.</citation>
    <PMID>24282112</PMID>
  </reference>
  <reference>
    <citation>Bateman ED, Boushey HA, Bousquet J, Busse WW, Clark TJ, Pauwels RA, Pedersen SE; GOAL Investigators Group. Can guideline-defined asthma control be achieved? The Gaining Optimal Asthma ControL study. Am J Respir Crit Care Med. 2004 Oct 15;170(8):836-44. doi: 10.1164/rccm.200401-033OC. Epub 2004 Jul 15.</citation>
    <PMID>15256389</PMID>
  </reference>
  <reference>
    <citation>Herdman M, Gudex C, Lloyd A, Janssen M, Kind P, Parkin D, Bonsel G, Badia X. Development and preliminary testing of the new five-level version of EQ-5D (EQ-5D-5L). Qual Life Res. 2011 Dec;20(10):1727-36. doi: 10.1007/s11136-011-9903-x. Epub 2011 Apr 9.</citation>
    <PMID>21479777</PMID>
  </reference>
  <reference>
    <citation>Kumar R, Seibold MA, Aldrich MC, Williams LK, Reiner AP, Colangelo L, Galanter J, Gignoux C, Hu D, Sen S, Choudhry S, Peterson EL, Rodriguez-Santana J, Rodriguez-Cintron W, Nalls MA, Leak TS, O'Meara E, Meibohm B, Kritchevsky SB, Li R, Harris TB, Nickerson DA, Fornage M, Enright P, Ziv E, Smith LJ, Liu K, Burchard EG. Genetic ancestry in lung-function predictions. N Engl J Med. 2010 Jul 22;363(4):321-30. doi: 10.1056/NEJMoa0907897. Epub 2010 Jul 7.</citation>
    <PMID>20647190</PMID>
  </reference>
  <reference>
    <citation>Park HW, Tantisira KG, Weiss ST. Pharmacogenomics in asthma therapy: where are we and where do we go? Annu Rev Pharmacol Toxicol. 2015;55:129-47. doi: 10.1146/annurev-pharmtox-010814-124543. Epub 2014 Sep 29.</citation>
    <PMID>25292431</PMID>
  </reference>
  <reference>
    <citation>Wechsler ME, Kunselman SJ, Chinchilli VM, Bleecker E, Boushey HA, Calhoun WJ, Ameredes BT, Castro M, Craig TJ, Denlinger L, Fahy JV, Jarjour N, Kazani S, Kim S, Kraft M, Lazarus SC, Lemanske RF Jr, Markezich A, Martin RJ, Permaul P, Peters SP, Ramsdell J, Sorkness CA, Sutherland ER, Szefler SJ, Walter MJ, Wasserman SI, Israel E; National Heart, Lung and Blood Institute's Asthma Clinical Research Network. Effect of beta2-adrenergic receptor polymorphism on response to longacting beta2 agonist in asthma (LARGE trial): a genotype-stratified, randomised, placebo-controlled, crossover trial. Lancet. 2009 Nov 21;374(9703):1754-64. doi: 10.1016/S0140-6736(09)61492-6.</citation>
    <PMID>19932356</PMID>
  </reference>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 9, 2017</study_first_submitted>
  <study_first_submitted_qc>August 9, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 14, 2017</study_first_posted>
  <last_update_submitted>August 9, 2017</last_update_submitted>
  <last_update_submitted_qc>August 9, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 14, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>asthma</keyword>
  <keyword>mobile application</keyword>
  <keyword>mobile app</keyword>
  <keyword>mobile health applications</keyword>
  <keyword>asthma mobile health application</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Asthma</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03248869
org study id: GCO 15-0063
nct id: NCT03248869
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
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).
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.
allocation: Non-Randomized
intervention model: Parallel Assignment
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
masking: None (Open Label)
measure: Number of downloads
time frame: 2 years
description: Number of people who downloaded AMHA
measure: Percent of participants who aborted study participation
time frame: 2 years
description: Percent of aborted study participants before completion inclusion/exclusion criteria
measure: Frequency of use of the Daily asthma diary
time frame: 2 years
description: Feasibility and implied participant acceptability by counting frequency of use of app
measure: Frequency of use of the Asthma Control (AC) questionnaire
time frame: 2 years
description: Feasibility and implied participant acceptability by counting frequency of use of app
measure: Frequency of use of the Health Care Utilization (HCU) questionnaire
time frame: 2 years
description: Feasibility and implied participant acceptability by counting frequency of use of app
measure: Percent of completion of Daily asthma diary
time frame: 2 years
description: Feasibility and implied participant acceptability by counting percent of completion of features in AMHA
measure: Percent of completion of the Asthma Control (AC) questionnaire
time frame: 2 years
description: Feasibility and implied participant acceptability by counting percent of completion of features in AMHA
measure: Percent of completion of the Health Care Utilization (HCU) questionnaire
time frame: 2 years
description: Feasibility and implied participant acceptability by counting percent of completion of features in AMHA
measure: Frequency of use of optional AMHA features
time frame: 2 years
description: Feasibility and implied participant acceptability by frequency of use of optional AMHA features
measure: Asthma Control (AC) questionnaire
time frame: up to 6 months
description: 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)
measure: EuroQol 5D-5L (EQ-5D-5L)
time frame: up to 6 months
description: 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.
measure: Health Care Utilization (HCU) score
time frame: up to 6 months
description: Questionnaire regarding HCU events with scores from 0 (no health services used to 10 (all health care service options utilized).
measure: Associations between genetic markers and asthma severity
time frame: 2 years
description: 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.
measure: Associations between genetic markers and symptom patterns
time frame: 2 years
description: 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.
measure: Associations between genetic markers and medication use/response
time frame: 2 years
description: 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.
arm group label: Current Daily Survey
arm group type: Active Comparator
description: need description
arm group label: Mobile Health App (MHA)
arm group type: Experimental
description: Participants download the mobile health app via the Apple App Store
intervention type: Other
intervention name: Current Daily Survey
description: need description
arm group label: Current Daily Survey
intervention type: Other
intervention name: Mobile Health App
description: Participants recruited, consented and enrolled via the AMHA and complete assessments using the app
arm group label: Mobile Health App (MHA)
other name: Asthma Mobile Health App
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Yu-feng Y Chan, MD, PhD
role: Principal Investigator
affiliation: Icahn School of Medicine at Mount Sinai
facility: 
country: United States
url: https://www.cdc.gov/vitalsigns/
description: CDC Vital Signs May 2011, accessed 9/13/14
url: http://ginasthma.org
description: Global Strategy for Asthma Management and Prevention, Global Initiative for Asthma (GINA) 2014.
citation: Murphy KR, Meltzer EO, Blaiss MS, Nathan RA, Stoloff SW, Doherty DE. Asthma management and control in the United States: results of the 2009 Asthma Insight and Management survey. Allergy Asthma Proc. 2012 Jan-Feb;33(1):54-64. doi: 10.2500/aap.2011.32.3518. Epub 2011 Dec 15.
PMID: 22309716
citation: Demoly P, Annunziata K, Gubba E, Adamek L. Repeated cross-sectional survey of patient-reported asthma control in Europe in the past 5 years. Eur Respir Rev. 2012 Mar 1;21(123):66-74. doi: 10.1183/09059180.00008111.
PMID: 22379176
citation: Eakin MN, Rand CS. Improving patient adherence with asthma self-management practices: what works? Ann Allergy Asthma Immunol. 2012 Aug;109(2):90-2. doi: 10.1016/j.anai.2012.06.009. No abstract available.
PMID: 22840247
citation: Tran N, Coffman JM, Sumino K, Cabana MD. Patient reminder systems and asthma medication adherence: a systematic review. J Asthma. 2014 Jun;51(5):536-43. doi: 10.3109/02770903.2014.888572. Epub 2014 Feb 13.
PMID: 24506699
citation: Foster JM, Usherwood T, Smith L, Sawyer SM, Xuan W, Rand CS, Reddel HK. Inhaler reminders improve adherence with controller treatment in primary care patients with asthma. J Allergy Clin Immunol. 2014 Dec;134(6):1260-1268.e3. doi: 10.1016/j.jaci.2014.05.041. Epub 2014 Jul 22.
PMID: 25062783
citation: Marcano Belisario JS, Huckvale K, Greenfield G, Car J, Gunn LH. Smartphone and tablet self management apps for asthma. Cochrane Database Syst Rev. 2013 Nov 27;2013(11):CD010013. doi: 10.1002/14651858.CD010013.pub2.
PMID: 24282112
citation: Bateman ED, Boushey HA, Bousquet J, Busse WW, Clark TJ, Pauwels RA, Pedersen SE; GOAL Investigators Group. Can guideline-defined asthma control be achieved? The Gaining Optimal Asthma ControL study. Am J Respir Crit Care Med. 2004 Oct 15;170(8):836-44. doi: 10.1164/rccm.200401-033OC. Epub 2004 Jul 15.
PMID: 15256389
citation: Herdman M, Gudex C, Lloyd A, Janssen M, Kind P, Parkin D, Bonsel G, Badia X. Development and preliminary testing of the new five-level version of EQ-5D (EQ-5D-5L). Qual Life Res. 2011 Dec;20(10):1727-36. doi: 10.1007/s11136-011-9903-x. Epub 2011 Apr 9.
PMID: 21479777
citation: Kumar R, Seibold MA, Aldrich MC, Williams LK, Reiner AP, Colangelo L, Galanter J, Gignoux C, Hu D, Sen S, Choudhry S, Peterson EL, Rodriguez-Santana J, Rodriguez-Cintron W, Nalls MA, Leak TS, O'Meara E, Meibohm B, Kritchevsky SB, Li R, Harris TB, Nickerson DA, Fornage M, Enright P, Ziv E, Smith LJ, Liu K, Burchard EG. Genetic ancestry in lung-function predictions. N Engl J Med. 2010 Jul 22;363(4):321-30. doi: 10.1056/NEJMoa0907897. Epub 2010 Jul 7.
PMID: 20647190
citation: Park HW, Tantisira KG, Weiss ST. Pharmacogenomics in asthma therapy: where are we and where do we go? Annu Rev Pharmacol Toxicol. 2015;55:129-47. doi: 10.1146/annurev-pharmtox-010814-124543. Epub 2014 Sep 29.
PMID: 25292431
citation: Wechsler ME, Kunselman SJ, Chinchilli VM, Bleecker E, Boushey HA, Calhoun WJ, Ameredes BT, Castro M, Craig TJ, Denlinger L, Fahy JV, Jarjour N, Kazani S, Kim S, Kraft M, Lazarus SC, Lemanske RF Jr, Markezich A, Martin RJ, Permaul P, Peters SP, Ramsdell J, Sorkness CA, Sutherland ER, Szefler SJ, Walter MJ, Wasserman SI, Israel E; National Heart, Lung and Blood Institute's Asthma Clinical Research Network. Effect of beta2-adrenergic receptor polymorphism on response to longacting beta2 agonist in asthma (LARGE trial): a genotype-stratified, randomised, placebo-controlled, crossover trial. Lancet. 2009 Nov 21;374(9703):1754-64. doi: 10.1016/S0140-6736(09)61492-6.
PMID: 19932356
responsible party type: Sponsor
mesh term: Asthma