ASTHMA-Educator Mobile Application Manage Asthma

Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03518879
• Other study ID #: 2013-2693
• Status: Completed
• Phase: N/A
• Start date: March 2015
• Est. completion date: July 1, 2021

Study information

• Verified date: June 2023
• Source: Montefiore Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: July 1, 2021
• Est. primary completion date: July 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Asthma

Intervention

Other:
• ASTHMA-Educator mobile application
The on-site delivered ASTHMA-Educator mobile application.

Locations

Country	Name	City	State
United States	Montefiore Medical Center	Bronx	New York

Sponsors (1)

Lead Sponsor	Collaborator
Montefiore Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Time spent in using the mobile application	Time spent in using the mobile application	Immediately post-intervention at the baseline visit
Secondary	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
Secondary	Asthma emergency department visits	Asthma emergency department visits	Baseline, 2 months, 4 months, 6 months
Secondary	Asthma hospitalizations	Asthma hospitalizations	Baseline, 2 months, 4 months, 6 months
Secondary	Asthma-related steroid courses	Asthma-related steroid courses	Baseline, 2 months, 4 months, 6 months