Back to resultsASTHMA-Educator Mobile Application Manage Asthma
Primary Purpose
Asthma
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ASTHMA-Educator mobile application
Sponsored by
About this trial
This is an interventional health services research trial for Asthma focused on measuring informatics, asthma
Eligibility Criteria
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.
Sites / Locations
- Montefiore Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
ASTHMA-Educator arm
Arm Description
The ASTHMA-Educator mobile application for patient-centered asthma education. The application is administered via on-site iPad (tablet).
Outcomes
Primary Outcome Measures
Change from baseline asthma control to 2, 4, and 6 months
Asthma symptom burden as measured by the Asthma Control Test
Secondary Outcome Measures
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
Patient satisfaction measured by the Client Satisfaction Questionnaire-8
Patient satisfaction measured by the Client Satisfaction Questionnaire-8
Time spent in using the mobile application
Time spent in using the mobile application
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)
Asthma emergency department visits
Asthma emergency department visits
Asthma hospitalizations
Asthma hospitalizations
Asthma-related steroid courses
Asthma-related steroid courses
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03518879
Brief Title
ASTHMA-Educator Mobile Application Manage Asthma
Official Title
The ASTHMA-Educator: A Novel Algorithmic Software Tool to Help Manage Asthma
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
March 2015 (Actual)
Primary Completion Date
July 1, 2021 (Actual)
Study Completion Date
July 1, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Montefiore Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
informatics, asthma
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
This is a single-arm proof of concept study to evaluate the impact of the ASTHMA-Educator on process and clinical outcomes
Masking
None (Open Label)
Allocation
N/A
Enrollment
70 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ASTHMA-Educator arm
Arm Type
Experimental
Arm Description
The ASTHMA-Educator mobile application for patient-centered asthma education. The application is administered via on-site iPad (tablet).
Intervention Type
Other
Intervention Name(s)
ASTHMA-Educator mobile application
Intervention Description
The on-site delivered ASTHMA-Educator mobile application.
Primary Outcome Measure Information:
Title
Change from baseline asthma control to 2, 4, and 6 months
Description
Asthma symptom burden as measured by the Asthma Control Test
Time Frame
Baseline, 2 months, 4 months, 6 months
Secondary Outcome Measure Information:
Title
Change from baseline asthma knowledge to immediately post-intervention, 2 months, 4 months, and 6 months
Description
Asthma knowledge as measured by the validated Asthma Knowledge Questionnaire
Time Frame
Baseline, immediately post-intervention, 2 months, 4 months, 6 months
Title
Patient satisfaction measured by the Client Satisfaction Questionnaire-8
Description
Patient satisfaction measured by the Client Satisfaction Questionnaire-8
Time Frame
Immediately post-intervention at the baseline visit, 2 months, 4 months, 6 months
Title
Time spent in using the mobile application
Description
Time spent in using the mobile application
Time Frame
Immediately post-intervention at the baseline visit
Title
Asthma quality of life measured by the mini-Asthma Quality of Life Questionnaire (mini-AQLQ)
Description
Patients' asthma quality of life measured by the mini-Asthma Quality of Life Questionnaire (mini-AQLQ)
Time Frame
Baseline, 2 months, 4 months, 6 months
Title
Asthma emergency department visits
Description
Asthma emergency department visits
Time Frame
Baseline, 2 months, 4 months, 6 months
Title
Asthma hospitalizations
Description
Asthma hospitalizations
Time Frame
Baseline, 2 months, 4 months, 6 months
Title
Asthma-related steroid courses
Description
Asthma-related steroid courses
Time Frame
Baseline, 2 months, 4 months, 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sunit Jariwala
Organizational Affiliation
Montefiore Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
The investigators will share de-identified and aggregated study findings.
Learn more about this trial
ASTHMA-Educator Mobile Application Manage Asthma
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