Electronic Monitoring of Medication Adherence in Moderate to Severe Asthma Patients

Not Applicable

Completed

• Conditions: Asthma
• Interventions: Behavioral: Electronic sensor and OW education

• Registration Number: NCT02913092
• Lead Sponsor: Montefiore Medical Center

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 Timeline

• Study First Submitted: 2016-09-18
• Study First Submitted QC: 2016-09-21
• Study First Posted: 2016-09-23
• Study Start: 2017-05-17
• Primary Completion: 2019-07-15
• Study Completion: 2022-05-23
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-18
• Last Update Posted: 2022-08-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 81

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Electronic sensor and OW education	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

Primary Outcome Measures

Name	Time	Method
Asthma Control Test	change from baseline to 6 months	validated asthma control measure

Secondary Outcome Measures

Name	Time	Method
Medication adherence	change from baseline to 6 months	measured by electronic sensor
Health care utilization	change from baseline to 6 months	ED visits and hospitalizations will be assessed via electronic health records

Trial Locations

Locations (1)

Montefiore Medical Center; 🇺🇸 Bronx, New York, United States