ASTHMA-Educator Mobile Application Manage Asthma

The ASTHMA-Educator: A Novel Algorithmic Software Tool to Help Manage Asthma

Through this study, the investigators developed the ASTHMA-Educator mobile application, and evaluated its use among adult asthma patients at Montefiore.

Study Overview

• Status: Completed
• Conditions: Asthma
• Intervention / Treatment: Other: ASTHMA-Educator mobile application

Detailed Description

Through this study, the investigators developed the ASTHMA-Educator mobile application, and evaluated its use through 2 phases: 1) Phase 1 = process outcomes evaluation with 30 patients); and 2) Phase 2 (longitudinal clinical evaluation with 40 patients receiving the intervention at baseline, 2 months, 4 months, and 6 months). The study's primary outcome is asthma control.

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Bronx, New York, United States, 10467
      • Montefiore Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria: Adults (>18 years) with: (a) severe asthma (i.e. at least one asthma-related ED visit and/or hospitalization in the previous year); (b) access to a smartphone with short message service (SMS) capability; (c) English speaking; (d) able to give informed consent.

Exclusion Criteria: (a) use of oral corticosteroids in the 2 weeks prior to the baseline visit; (b) pregnancy; (c) severe psychiatric or cognitive problems that would prohibit an individual from understanding and completing the protocol; and (d) patients that previously received the ASTHMAXcel application.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ASTHMA-Educator arm; The ASTHMA-Educator mobile application for patient-centered asthma education. The application is administered via on-site iPad (tablet).	Other: ASTHMA-Educator mobile application; The on-site delivered ASTHMA-Educator mobile application.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline asthma control to 2, 4, and 6 months	Asthma symptom burden as measured by the Asthma Control Test	Baseline, 2 months, 4 months, 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline asthma knowledge to immediately post-intervention, 2 months, 4 months, and 6 months	Asthma knowledge as measured by the validated Asthma Knowledge Questionnaire	Baseline, immediately post-intervention, 2 months, 4 months, 6 months
Patient satisfaction measured by the Client Satisfaction Questionnaire-8	Patient satisfaction measured by the Client Satisfaction Questionnaire-8	Immediately post-intervention at the baseline visit, 2 months, 4 months, 6 months
Time spent in using the mobile application	Time spent in using the mobile application	Immediately post-intervention at the baseline visit
Asthma quality of life measured by the mini-Asthma Quality of Life Questionnaire (mini-AQLQ)	Patients' asthma quality of life measured by the mini-Asthma Quality of Life Questionnaire (mini-AQLQ)	Baseline, 2 months, 4 months, 6 months
Asthma emergency department visits	Asthma emergency department visits	Baseline, 2 months, 4 months, 6 months
Asthma hospitalizations	Asthma hospitalizations	Baseline, 2 months, 4 months, 6 months
Asthma-related steroid courses	Asthma-related steroid courses	Baseline, 2 months, 4 months, 6 months

Collaborators and Investigators

• Sponsor: Montefiore Medical Center
• Investigators: Principal Investigator: Sunit Jariwala, Montefiore Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2015
• Primary Completion (Actual): July 1, 2021
• Study Completion (Actual): July 1, 2021

Study Registration Dates

• First Submitted: April 13, 2018
• First Submitted That Met QC Criteria: April 25, 2018
• First Posted (Actual): May 8, 2018

Study Record Updates

• Last Update Posted (Actual): June 7, 2023
• Last Update Submitted That Met QC Criteria: June 6, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: asthma; informatics
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma
• Other Study ID Numbers: 2013-2693

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: The investigators will share de-identified and aggregated study findings.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No