Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
7752 participants
INTERVENTIONAL
2015-03-15
2017-03-15
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
DEVICE_FEASIBILITY
NONE
Study Groups
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Current Daily Survey
need description
Current Daily Survey
need description
Mobile Health App (MHA)
Participants download the mobile health app via the Apple App Store
Mobile Health App
Participants recruited, consented and enrolled via the AMHA and complete assessments using the app
Interventions
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Current Daily Survey
need description
Mobile Health App
Participants recruited, consented and enrolled via the AMHA and complete assessments using the app
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
Yes
Sponsors
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Apple Inc.
INDUSTRY
Lifemap Solutions, Inc
UNKNOWN
Sage Bionetworks
OTHER
Icahn School of Medicine at Mount Sinai
OTHER
Responsible Party
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Principal Investigators
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Yu-feng Y Chan, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Icahn School of Medicine at Mount Sinai
Locations
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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
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Related Links
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CDC Vital Signs May 2011, accessed 9/13/14
Global Strategy for Asthma Management and Prevention, Global Initiative for Asthma (GINA) 2014.
Other Identifiers
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GCO 15-0063
Identifier Type: -
Identifier Source: org_study_id
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