Electronic Monitoring of Medication Adherence in Moderate to Severe Asthma Patients

Asthma Clinical Trial

Official title:

Electronic Monitoring of Medication Adherence in Moderate to Severe Asthma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02913092
• Other study ID #: 2016-7001
• Secondary ID: Community Servic
• Status: Completed
• Phase: N/A
• Start date: May 17, 2017
• Est. completion date: May 23, 2022

Study information

• Verified date: August 2022
• Source: Montefiore Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 81
• Est. completion date: May 23, 2022
• Est. primary completion date: July 15, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Asthma

Intervention

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

Locations

Country	Name	City	State
United States	Montefiore Medical Center	Bronx	New York

Sponsors (2)

Lead Sponsor	Collaborator
Montefiore Medical Center	Stony Wold-Herbert Fund, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Asthma Control Test	validated asthma control measure	change from baseline to 6 months
Secondary	Medication adherence	measured by electronic sensor	change from baseline to 6 months
Secondary	Health care utilization	ED visits and hospitalizations will be assessed via electronic health records	change from baseline to 6 months