Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

Tracking Information
First Submitted Date  ICMJE September 18, 2016
First Posted Date  ICMJE September 23, 2016
Last Update Posted Date April 8, 2020
Actual Study Start Date  ICMJE May 17, 2017
Actual Primary Completion Date July 15, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 21, 2016)
Asthma Control Test [ Time Frame: change from baseline to 6 months ]
validated asthma control measure
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 15, 2018)
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: September 21, 2016)
  • Medication adherence [ Time Frame: change from baseline to 6 months ]
    measured by electronic sensor
  • Quality of Life [ Time Frame: change from baseline to 6 months ]
    validated survey
  • Health care utilization [ Time Frame: change from baseline to 6 months ]
    ED visits and hospitalizations will be assessed via electronic health records
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Electronic Monitoring of Medication Adherence in Moderate to Severe Asthma Patients
Official Title  ICMJE Electronic Monitoring of Medication Adherence in Moderate to Severe Asthma
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Health Services Research
Condition  ICMJE Asthma
Intervention  ICMJE 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
Study Arms  ICMJE
  • 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
    Intervention: Behavioral: Electronic sensor and OW education
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: December 16, 2019)
81
Original Estimated Enrollment  ICMJE
 (submitted: September 21, 2016)
80
Estimated Study Completion Date  ICMJE December 2020
Actual Primary Completion Date July 15, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 5 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02913092
Other Study ID Numbers  ICMJE 2016-7001
Community Service Award ( Other Grant/Funding Number: Stony Wold-Herbert Fund )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Marina Reznik, Montefiore Medical Center
Study Sponsor  ICMJE Montefiore Medical Center
Collaborators  ICMJE Stony Wold-Herbert Fund, Inc.
Investigators  ICMJE
Principal Investigator: Marina Reznik, MD, MS Montefiore Medical Center
PRS Account Montefiore Medical Center
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP