Electronic Monitoring of Medication Adherence in Moderate to Severe Asthma Patients
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ClinicalTrials.gov Identifier: NCT02913092 |
Recruitment Status :
Active, not recruiting
First Posted : September 23, 2016
Last Update Posted : March 23, 2021
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Condition or disease | Intervention/treatment | Phase |
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Asthma | Behavioral: Electronic sensor and OW education | Not Applicable |
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.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 81 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Outcomes Assessor) |
Primary Purpose: | Health Services Research |
Official Title: | Electronic Monitoring of Medication Adherence in Moderate to Severe Asthma |
Actual Study Start Date : | May 17, 2017 |
Actual Primary Completion Date : | July 15, 2019 |
Estimated Study Completion Date : | June 29, 2021 |
Arm | Intervention/treatment |
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Experimental: Electronic sensor and OW education
MDI sensor-generated alerts will be relayed and responded to (e.g. outreach worker contacts the participant 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 asthma education over the phone
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Behavioral: Electronic sensor and OW education
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 |
No Intervention: Usual Care
Usual care group will receive the electronic tracker but the sensor-generated alerts will not be delivered. If the usual care group rescue inhaler data reveals frequent use of rescue medication (daily use for >3 days) investigators will reach out (via app or phone call) to advise the participant to see their physician
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- Asthma Control Test [ Time Frame: change from baseline to 6 months ]validated asthma control measure
- Medication adherence [ Time Frame: change from baseline to 6 months ]measured by electronic sensor
- Health care utilization [ Time Frame: change from baseline to 6 months ]ED visits and hospitalizations will be assessed via electronic health records

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Ages Eligible for Study: | 5 Years and older (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02913092
United States, New York | |
Montefiore Medical Center | |
Bronx, New York, United States, 10467 |
Principal Investigator: | Marina Reznik, MD, MS | Montefiore Medical Center |
Responsible Party: | Montefiore Medical Center |
ClinicalTrials.gov Identifier: | NCT02913092 |
Other Study ID Numbers: |
2016-7001 Community Service Award ( Other Grant/Funding Number: Stony Wold-Herbert Fund ) |
First Posted: | September 23, 2016 Key Record Dates |
Last Update Posted: | March 23, 2021 |
Last Verified: | March 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Asthma Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases |
Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases |