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OpenTrials
Completed

NCT Number: NCT02913092

Electronic Monitoring of Medication Adherence in Moderate to Severe Asthma Patients

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

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Key information

Age range

5 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Montefiore Medical Center

The Bronx, New York, 10467, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Electronic sensor and OW education

Behavioral

MDI sensor-generated alerts will be relayed via app platform on participant's phone and responded to (e.g. outreach worker contacts the patient for a missed dose) in real-time to the intervention group. Outreach worker will also assess intervention group participants' need for further asthma education and provide education over the phone

Primary outcomes

  1. Asthma Control Test

    Time frame: change from baseline to 6 months

    validated asthma control measure

Secondary outcomes

  1. Medication adherence

    Time frame: change from baseline to 6 months

    measured by electronic sensor

  2. Health care utilization

    Time frame: change from baseline to 6 months

    ED visits and hospitalizations will be assessed via electronic health records

Sponsors and collaborators

Lead sponsor

Montefiore Medical Center

Other

Collaborators

  • Stony Wold-Herbert Fund, Inc.

Registry information

Official study title

Electronic Monitoring of Medication Adherence in Moderate to Severe Asthma

Important dates

Study start
2017
Primary completion
2019
Study completion
2022
First posted
Sep 23, 2016
Registry last updated
Aug 22, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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