Electronic Monitoring of Medication Adherence in Moderate to Severe Asthma Patients

NCT ID: NCT02913092

Last Updated: 2022-08-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 81 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-05-17
• Study Completion Date: 2022-05-23

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.

Conditions

Asthma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: EXPERIMENTAL

Electronic sensor and OW education

Intervention Type: BEHAVIORAL

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

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 5 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stony Wold-Herbert Fund, Inc.

OTHER

Sponsor Role: collaborator

Montefiore Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Marina Reznik

Associate Professor of Pediatrics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Marina Reznik, MD, MS

Role: PRINCIPAL_INVESTIGATOR

Montefiore Medical Center

Locations

Montefiore Medical Center

The Bronx, New York, United States

Countries

United States

Other Identifiers

Community Service Award

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

2016-7001

Identifier Type: -

Identifier Source: org_study_id