Community Empowerment to Pilot a Novel Device for Monitoring Rescue Medication Use in Urban Children With Asthma

NCT02517047 | Completed Results

• 1 other identifier: P00018778
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Pediatric asthma is the most common chronic illness among children and is associated with poor quality of life, activity restriction, school absences, and thousands of physician visits annually. The purpose of this study is to measure the effectiveness of using an innovative tracking system (CareTRx) for the self-management of asthma, including daily and rescue medication use, among children and adolescents with pediatric asthma.

Conditions

Asthma

Outcome Measures

Primary Outcomes (2)

• Number of Participants With Daily Medication Compliance

  Total number participants who took their medication as planned will be measured. This will include measuring the number of participants with medication compliance who take their medications as planned based on the data from the monitoring device.

  12 weeks

• Number of Participants With Rescue Inhaler Use

  Total number participants with rescue inhaler use throughout the course of the study.

  12 weeks

Secondary Outcomes (2)

• Asthma Symptoms

  12 weeks

• Forced Expiratory Volume

  Baseline

Study Arms (1)

CareTRx Device

EXPERIMENTAL

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.

Device: CareTRx

Interventions

CareTRx DEVICE

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.

CareTRx Device

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Youth with a primary diagnosis of persistent asthma according by NHLBI criteria
• Females or males between the ages of 6-17 years of age
• 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

You may not qualify if:

• Youth with other cardiac, pulmonary, or neuromuscular disorders that impact breathing
• Youth with documented developmental delays or impairments that would interfere with ability to use CareTRx system

Sponsors & Collaborators

• Boston Children's Hospital: lead

Study Sites (1)

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Location

Related Publications (18)

• 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.

  BACKGROUND

• 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.

  PMID: 9099758 BACKGROUND

• 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.

  PMID: 16094284 BACKGROUND

• 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.

  PMID: 12165584 BACKGROUND

• 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

  BACKGROUND

• Rapoff, MA. Adherence to pediatric medical regimens, 2nd ed. 2010; New York: Springer

  BACKGROUND

• 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.

  PMID: 12218770 BACKGROUND

• 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.

  PMID: 10617735 BACKGROUND

• 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.

  PMID: 21942628 BACKGROUND

• 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

  BACKGROUND

• 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

  BACKGROUND

• Rapoff MA, Lootens CC, Tsai MS. Assessing adherence and barriers to adherence in pediatric asthma. Resp. Drug Deliv. 2012; 1-12

  BACKGROUND

• 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.

  PMID: 21722917 BACKGROUND

• 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.

  PMID: 17161749 BACKGROUND

• 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.

  PMID: 12689739 BACKGROUND

• 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.

  PMID: 14736583 BACKGROUND

• 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.

  PMID: 17846042 BACKGROUND

• 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.

  PMID: 32574599 DERIVED

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

Results Point of Contact

• Title: Dr. Wanda Phipatanakul
• Organization: Boston Children's Hospital

wanda.phipatanakul@childrens.harvard.edu

6173556117

Study Officials

• Wanda Phipatanakul, MD, MS

  Boston Children's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: July 27, 2015
• First Posted: August 6, 2015
• Study Start: March 1, 2016
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: June 7, 2018
• Results First Posted: April 2, 2018

Record last verified: 2018-05

Locations

US (1)