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Electronic Monitoring of Medication Adherence in Moderate to Severe Asthma Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02913092
Recruitment Status : Active, not recruiting
First Posted : September 23, 2016
Last Update Posted : April 8, 2020
Sponsor:
Collaborator:
Stony Wold-Herbert Fund, Inc.
Information provided by (Responsible Party):
Marina Reznik, Montefiore Medical Center

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

Condition or disease Intervention/treatment Phase
Asthma Behavioral: Electronic sensor and OW education Not Applicable

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.

Study Design
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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 : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arms and Interventions
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Arm Intervention/treatment
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
 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


Outcome Measures
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Primary Outcome Measures :
  1. Asthma Control Test [ Time Frame: change from baseline to 6 months ]
    validated asthma control measure


Secondary Outcome Measures :
  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


Eligibility Criteria
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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
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
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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United States, New York
Montefiore Medical Center
Bronx, New York, United States, 10467
Sponsors and Collaborators
Montefiore Medical Center
Stony Wold-Herbert Fund, Inc.
Investigators
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Principal Investigator: Marina Reznik, MD, MS Montefiore Medical Center
More Information
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Responsible Party: Marina Reznik, Associate Professor of Pediatrics, 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: April 8, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
 Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases