Clincosm LogoSign in Get a demo

Electronic Monitoring of Medication Adherence in Moderate to Severe Asthma Patients

Sponsor
Montefiore Medical Center (Other)
Overall Status
Completed
CT.gov ID
NCT02913092
Collaborator
Stony Wold-Herbert Fund, Inc. (Other)
81
Enrollment
1
Location
2
Arms
60.2
Actual Duration (Months)
1.3
Patients Per Site Per Month

Study Details

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

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Electronic sensor and OW education
 N/A

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

Study Type:
Interventional
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 :
Jul 15, 2019
Actual Study Completion Date :
May 23, 2022

Arms and Interventions

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

Primary Outcome Measures

  1. Asthma Control Test [change from baseline to 6 months]

    validated asthma control measure

Secondary Outcome Measures

  1. Medication adherence [change from baseline to 6 months]

    measured by electronic sensor

  2. Health care utilization [change from baseline to 6 months]

    ED visits and hospitalizations will be assessed via electronic health records

Eligibility Criteria

Criteria

Ages Eligible for Study:
5 Years and Older
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Montefiore Medical Center Bronx New York United States 10467

Sponsors and Collaborators

  • Montefiore Medical Center
  • Stony Wold-Herbert Fund, Inc.

Investigators

  • Principal Investigator: Marina Reznik, MD, MS, Montefiore Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Marina Reznik, Associate Professor of Pediatrics, Montefiore Medical Center
ClinicalTrials.gov Identifier:
NCT02913092
Other Study ID Numbers:
  • 2016-7001
  • Community Service Award
First Posted:
Sep 23, 2016
Last Update Posted:
Aug 22, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Asthma

Study Results

No Results Posted as of Aug 22, 2022