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Clinical Trials/NCT02913092
NCT02913092
Completed
Not Applicable

Electronic Monitoring of Medication Adherence in Moderate to Severe Asthma

Montefiore Medical Center1 site in 1 country81 target enrollmentMay 17, 2017
ConditionsAsthma

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Asthma
Sponsor
Montefiore Medical Center
Enrollment
81
Locations
1
Primary Endpoint
Asthma Control Test
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

This study will evaluate the role of using electronic sensors for asthma inhaler devices in monitoring medication adherence and asthma control

Detailed Description

This study will assess the feasibility of using electronic sensors for asthma inhalers in a population of urban minority adults and children with moderate-severe asthma in the Bronx. Investigators will also assess differences in asthma outcomes (specifically asthma control as a primary outcome measure) and treatment adherence in a group of participants with moderate-severe asthma who use inhalers with electronic sensors and real-time remote outreach worker monitoring/feedback compared to a group of participants who use inhalers with electronic sensors but without real-time monitoring/feedback.

Registry
clinicaltrials.gov
Start Date
May 17, 2017
End Date
May 23, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Marina Reznik

Associate Professor of Pediatrics

Montefiore Medical Center

Eligibility Criteria

Inclusion Criteria

  • Adults (\>18 years) and children (5-11 years old) with a clinical history (i.e. physician-diagnosed) of asthma
  • Moderate to severe asthmatics with ≥1 asthma-related ED visits or hospitalizations in the past year
  • Use of daily controller inhaler medications
  • Adult non-smokers, or lifetime use \<5 pack years with no smoking in last 1 yr
  • Smartphone required
  • English or Spanish speaking

Exclusion Criteria

  • No smartphone
  • Use of oral corticosteroids in prior 4 weeks
  • Pregnancy
  • Psychiatric conditions

Outcomes

Primary Outcomes

Asthma Control Test

Time Frame: change from baseline to 6 months

validated asthma control measure

Secondary Outcomes

  • Medication adherence(change from baseline to 6 months)
  • Health care utilization(change from baseline to 6 months)

Study Sites (1)

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