Electronic Monitoring of Medication Adherence in Moderate to Severe Asthma Patients

Montefiore Medicine Academic Health System

Status: Completed

Conditions: Asthma

Treatments: Behavioral: Electronic sensor and OW education

Study type: Interventional

Funder types: Other

Identifiers

NCT02913092

Community Service Award (Other Grant/Funding Number)

2016-7001

Details and patient eligibility

About

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

Full 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.

Enrollment: 81 patients

Sex: All

Ages: 5+ years old

Volunteers: No 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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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81 participants in 2 patient groups

Electronic sensor and OW education

Experimental group

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

Treatment:

Behavioral: Electronic sensor and OW education

Usual Care

No Intervention group

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