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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).
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
Yes
Dept. of Genetics and Genomic Sciences, Icahn Institute for Genomics and Multiscale Biology, Icahn School of Medicine at Mount Sinai
New York, New York, United States
Start Date
March 15, 2015
Primary Completion Date
March 15, 2017
Completion Date
March 15, 2017
Last Updated
August 14, 2017
7,752
ACTUAL participants
Current Daily Survey
OTHER
Mobile Health App
OTHER
Lead Sponsor
Icahn School of Medicine at Mount Sinai
Collaborators
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT07219173