Community Empowerment to Pilot a Novel Device for Monitoring Rescue Medication Use in Urban Children With Asthma
NCT ID: NCT02517047
Last Updated: 2018-06-07
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
NA
26 participants
INTERVENTIONAL
2016-03-31
2016-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Study Groups
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CareTRx Device
Subject will receive CareTRx device for rescue inhaler as well as the application downloaded to their Android phone. The device will track when the rescue inhaler is administered. The information will then be loaded to phone app.
CareTRx
CareTRx is a novel device that can be applied to most MDI (meter dose inhaler) device and leverages mobile and cloud computing to objectively assess and provide real-visualize feedback to patients and providers around medication adherence and disease control in pediatric asthma.
Interventions
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CareTRx
CareTRx is a novel device that can be applied to most MDI (meter dose inhaler) device and leverages mobile and cloud computing to objectively assess and provide real-visualize feedback to patients and providers around medication adherence and disease control in pediatric asthma.
Eligibility Criteria
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Inclusion Criteria
2. Females or males between the ages of 6-17 years of age
3. Youth or caregiver must have an Android smart phone with operating system 4.3 or above and data plan for the duration of the study period
Exclusion Criteria
2. Youth with documented developmental delays or impairments that would interfere with ability to use CareTRx system
6 Years
17 Years
ALL
No
Sponsors
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Boston Children's Hospital
OTHER
Responsible Party
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Wanda Phipatanakul
Principle Investigator
Principal Investigators
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Wanda Phipatanakul, MD, MS
Role: PRINCIPAL_INVESTIGATOR
Boston Children's Hospital
Locations
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Boston Children's Hospital
Boston, Massachusetts, United States
Countries
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References
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U.S. Department of Health and Human Services. Healthy People 2010: Understanding and Improving Health. 2nd ed. Washington DC: U.S. Government Printing Office; 2000.
Forrest CB, Starfield B, Riley AW, Kang M. The impact of asthma on the health status of adolescents. Pediatrics. 1997 Feb;99(2):E1. doi: 10.1542/peds.99.2.e1.
Centers for Disease Control and Prevention (CDC). Self-reported asthma among high school students--United States, 2003. MMWR Morb Mortal Wkly Rep. 2005 Aug 12;54(31):765-7.
Akinbami LJ, Schoendorf KC. Trends in childhood asthma: prevalence, health care utilization, and mortality. Pediatrics. 2002 Aug;110(2 Pt 1):315-22. doi: 10.1542/peds.110.2.315.
National Asthma Education and Prevention Program. Expert Panel Report II: guidelines for the diagnosis and management of asthma. Bethesda, MD: National Institutes of Health; 1997
Rapoff, MA. Adherence to pediatric medical regimens, 2nd ed. 2010; New York: Springer
DiMatteo MR, Giordani PJ, Lepper HS, Croghan TW. Patient adherence and medical treatment outcomes: a meta-analysis. Med Care. 2002 Sep;40(9):794-811. doi: 10.1097/00005650-200209000-00009.
Halterman JS, Aligne CA, Auinger P, McBride JT, Szilagyi PG. Inadequate therapy for asthma among children in the United States. Pediatrics. 2000 Jan;105(1 Pt 3):272-6.
Blaschke TF, Osterberg L, Vrijens B, Urquhart J. Adherence to medications: insights arising from studies on the unreliable link between prescribed and actual drug dosing histories. Annu Rev Pharmacol Toxicol. 2012;52:275-301. doi: 10.1146/annurev-pharmtox-011711-113247. Epub 2011 Sep 19.
Palermo TM, Wilson AC. eHealth applications in pediatric psychology. In MC Roberts,RG Steele (Eds.), Handbook of pediatric psychology (4th ed., pp. 227-237). 2009. New York: Guilford
Atienza AA, Stone AA, Shiffman S, Nebeling L. Introduction. In AA Stone, S Shiffman, AA Atienza, L Nebeling (Eds.), The science of real-time data capture: self-reports in health research. 2007; New York: Oxford
Rapoff MA, Lootens CC, Tsai MS. Assessing adherence and barriers to adherence in pediatric asthma. Resp. Drug Deliv. 2012; 1-12
Ingerski LM, Hente EA, Modi AC, Hommel KA. Electronic measurement of medication adherence in pediatric chronic illness: a review of measures. J Pediatr. 2011 Oct;159(4):528-34. doi: 10.1016/j.jpeds.2011.05.018. Epub 2011 Jul 1. No abstract available.
Dale O, Hagen KB. Despite technical problems personal digital assistants outperform pen and paper when collecting patient diary data. J Clin Epidemiol. 2007 Jan;60(1):8-17. doi: 10.1016/j.jclinepi.2006.04.005. Epub 2006 Aug 30.
Stone AA, Shiffman S, Schwartz JE, Broderick JE, Hufford MR. Patient compliance with paper and electronic diaries. Control Clin Trials. 2003 Apr;24(2):182-99. doi: 10.1016/s0197-2456(02)00320-3.
Palermo TM, Valenzuela D, Stork PP. A randomized trial of electronic versus paper pain diaries in children: impact on compliance, accuracy, and acceptability. Pain. 2004 Feb;107(3):213-219. doi: 10.1016/j.pain.2003.10.005.
Quittner AL, Modi AC, Lemanek KL, Ievers-Landis CE, Rapoff MA. Evidence-based assessment of adherence to medical treatments in pediatric psychology. J Pediatr Psychol. 2008 Oct;33(9):916-36; discussion 937-8. doi: 10.1093/jpepsy/jsm064. Epub 2007 Sep 10.
Behrooz L, Dilley MA, Petty CR, Huffaker MF, Sheehan WJ, Phipatanakul W. The efficacy of a novel monitoring device on asthma control in children with asthma. Ann Allergy Asthma Immunol. 2020 Sep;125(3):352-354. doi: 10.1016/j.anai.2020.06.025. Epub 2020 Jun 20. No abstract available.
Other Identifiers
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P00018778
Identifier Type: -
Identifier Source: org_study_id
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