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Electronic Monitoring of Medication Adherence in Moderate to Severe Asthma Patients

Primary Purpose

Asthma

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Electronic sensor and OW education
Sponsored by
Montefiore Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Asthma

Eligibility Criteria

5 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Montefiore Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Electronic sensor and OW education

Usual Care

Arm Description

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

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

Outcomes

Primary Outcome Measures

Asthma Control Test
validated asthma control measure

Secondary Outcome Measures

Medication adherence
measured by electronic sensor
Health care utilization
ED visits and hospitalizations will be assessed via electronic health records

Full Information

First Posted
September 18, 2016
Last Updated
August 18, 2022
Sponsor
Montefiore Medical Center
Collaborators
Stony Wold-Herbert Fund, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02913092
Brief Title
Electronic Monitoring of Medication Adherence in Moderate to Severe Asthma Patients
Official Title
Electronic Monitoring of Medication Adherence in Moderate to Severe Asthma
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
May 17, 2017 (Actual)
Primary Completion Date
July 15, 2019 (Actual)
Study Completion Date
May 23, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Montefiore Medical Center
Collaborators
Stony Wold-Herbert Fund, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
81 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Electronic sensor and OW education
Arm Type
Experimental
Arm Description
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
Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
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
Intervention Type
Behavioral
Intervention Name(s)
Electronic sensor and OW education
Intervention Description
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 Outcome Measure Information:
Title
Asthma Control Test
Description
validated asthma control measure
Time Frame
change from baseline to 6 months
Secondary Outcome Measure Information:
Title
Medication adherence
Description
measured by electronic sensor
Time Frame
change from baseline to 6 months
Title
Health care utilization
Description
ED visits and hospitalizations will be assessed via electronic health records
Time Frame
change from baseline to 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marina Reznik, MD, MS
Organizational Affiliation
Montefiore Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Electronic Monitoring of Medication Adherence in Moderate to Severe Asthma Patients

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