Electronic Monitoring of Medication Adherence in Moderate to Severe Asthma Patients

NCT02913092 | Completed

• 2 other identifiers: 2016-7001Community Service Award
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

• Asthma Control Test

  validated asthma control measure

  change from baseline to 6 months

Secondary Outcomes (2)

• Medication adherence

  change from baseline to 6 months

• Health care utilization

  change from baseline to 6 months

Study Arms (2)

Electronic sensor and OW education

EXPERIMENTAL

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

Usual Care

NO INTERVENTION

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

Interventions

Electronic sensor and OW education 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

Electronic sensor and OW education

Eligibility Criteria

• Age: 5 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• No smartphone
• Use of oral corticosteroids in prior 4 weeks
• Pregnancy
• Psychiatric conditions

Sponsors & Collaborators

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

Study Sites (1)

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Marina Reznik, MD, MS

  Montefiore Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Pediatrics

Study Record Dates

• First Submitted: September 18, 2016
• First Posted: September 23, 2016
• Study Start: May 17, 2017
• Primary Completion: July 15, 2019
• Study Completion: May 23, 2022
• Last Updated: August 22, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)