Asthma Mobile Health Application 2.0

NCT03248869 | Completed

• 1 other identifier: GCO 15-0063
• Study Type: interventional
• Target: 7,752
• Locations: 1 country
• Sites: 1

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).

Conditions

Asthma

Keywords

asthma; mobile application; mobile app; mobile health applications; asthma mobile health application

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (13)

• Frequency of use of the Daily asthma diary

  2 years

• Frequency of use of the Asthma Control (AC) questionnaire

  2 years

• Frequency of use of the Health Care Utilization (HCU) questionnaire

  2 years

• Percent of completion of Daily asthma diary

  2 years

• Percent of completion of the Asthma Control (AC) questionnaire

  2 years

Study Arms (2)

Current Daily Survey

ACTIVE COMPARATOR

need description

Other: Current Daily Survey

Mobile Health App (MHA)

EXPERIMENTAL

Participants download the mobile health app via the Apple App Store

Other: Mobile Health App

Interventions

Current Daily Survey OTHER

need description

Current Daily Survey

Mobile Health App OTHER

Participants recruited, consented and enrolled via the AMHA and complete assessments using the app

Also known as: Asthma Mobile Health App

Mobile Health App (MHA)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• \<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

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead
• Apple Inc.: collaborator
• Lifemap Solutions, Inc: collaborator
• Sage Bionetworks: collaborator

Study Sites (1)

Dept. of Genetics and Genomic Sciences, Icahn Institute for Genomics and Multiscale Biology, Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

Related Publications (11)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

Related Links

• CDC Vital Signs May 2011, accessed 9/13/14
• Global Strategy for Asthma Management and Prevention, Global Initiative for Asthma (GINA) 2014.

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Yu-feng Y Chan, MD, PhD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 9, 2017
• First Posted: August 14, 2017
• Study Start: March 15, 2015
• Primary Completion: March 15, 2017
• Study Completion: March 15, 2017
• Last Updated: August 14, 2017

Record last verified: 2017-08

Locations

US (1)