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

Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02517047
• Other study ID #: P00018778
• Status: Completed
• Phase: N/A
• Start date: March 2016
• Est. completion date: December 2016

Study information

• Verified date: May 2018
• Source: Boston Children’s Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

The primary study objective 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 with asthma. The study objectives will be achieved using a pre-post design for the participants. The investigators aim to enroll at least 26 participants for a 3-month intervention period. With this pilot study, the investigators hope to examine the impact of self-management behaviors on health outcomes including asthma symptoms and quality of life measures.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 17 Years

Eligibility

Inclusion Criteria:

1. Youth with a primary diagnosis of persistent asthma according by NHLBI 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:

1. Youth with other cardiac, pulmonary, or neuromuscular disorders that impact breathing

2. Youth with documented developmental delays or impairments that would interfere with ability to use CareTRx system

Related Conditions & MeSH terms

• Asthma

Intervention

Device:
• 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.

Locations

Country	Name	City	State
United States	Boston Children's Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Boston Children’s Hospital

Country where clinical trial is conducted

United States, 

References & Publications (17)

Akinbami LJ, Schoendorf KC. Trends in childhood asthma: prevalence, health care utilization, and mortality. Pediatrics. 2002 Aug;110(2 Pt 1):315-22. — View Citation

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

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. Review. — View Citation

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. — View Citation

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. Epub 2006 Aug 30. Review. — View Citation

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. — View Citation

Forrest CB, Starfield B, Riley AW, Kang M. The impact of asthma on the health status of adolescents. Pediatrics. 1997 Feb;99(2):E1. — View Citation

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. — View Citation

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. Review. — View Citation

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

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):213-9. — View Citation

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

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. Epub 2007 Sep 10. Review. — View Citation

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

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

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. — View Citation

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.

* Note: There are 17 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Number of Participants With Rescue Inhaler Use	Total number participants with rescue inhaler use throughout the course of the study.	12 weeks
Secondary	Asthma Symptoms	Asthma symptom control as a measure of effectiveness of self-management behavior on asthma control, measured by Asthma Control Test (ACT). Asthma control test is a survey used to evaluate asthma control in patients. It includes 5 multiple questions that ask about how much of the time patient was having asthma symptoms. The higher the score the better asthma control. Lower scores especially less than 19 represent poor asthma control. each question has 5 answers. The total score is the sum of all the scores from 5 questions. the maximum score on the test is 25 which is excellent asthma control and the lowest is 0 which defines extremely poor asthma control.	12 weeks
Secondary	Forced Expiratory Volume	Forced expiratory volume measured in liters is the volume of air which can be forcibly exhaled from the lungs in the first second of a forced expiration and helps with evaluation of asthma control. FEV1 was only measure at baseline to assess the participants asthma status at baseline.	Baseline