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Clinical Trials/NCT03518879
NCT03518879CompletedNot Applicable

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

Montefiore Medical Center1 site in 1 country70 target enrollmentStarted: March 1, 2015Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
70
Locations
1
Primary Endpoint
Change from baseline asthma control to 2, 4, and 6 months

Study Overview

Brief Summary

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

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 Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Health Services Research
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Arms & Interventions

ASTHMA-Educator arm

Experimental

The ASTHMA-Educator mobile application for patient-centered asthma education. The application is administered via on-site iPad (tablet).

Intervention: ASTHMA-Educator mobile application (Other)

Outcomes

Primary Outcomes

Change from baseline asthma control to 2, 4, and 6 months

Time Frame: Baseline, 2 months, 4 months, 6 months

Asthma symptom burden as measured by the Asthma Control Test

Secondary Outcomes

  • Patient satisfaction measured by the Client Satisfaction Questionnaire-8(Immediately post-intervention at the baseline visit, 2 months, 4 months, 6 months)
  • Change from baseline asthma knowledge to immediately post-intervention, 2 months, 4 months, and 6 months(Baseline, immediately post-intervention, 2 months, 4 months, 6 months)
  • 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)(Baseline, 2 months, 4 months, 6 months)
  • Asthma hospitalizations(Baseline, 2 months, 4 months, 6 months)
  • Asthma emergency department visits(Baseline, 2 months, 4 months, 6 months)
  • Asthma-related steroid courses(Baseline, 2 months, 4 months, 6 months)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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