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ASTHMA-Educator Mobile Application Manage Asthma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03518879
Recruitment Status : Completed
First Posted : May 8, 2018
Last Update Posted : May 16, 2018
Sponsor:
Information provided by (Responsible Party):
Sunit P. Jariwala, Montefiore Medical Center

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

Condition or disease Intervention/treatment Phase
Asthma Other: ASTHMA-Educator mobile application Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention 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)
Primary Purpose: Health Services Research
Official Title: The ASTHMA-Educator: A Novel Algorithmic Software Tool to Help Manage Asthma
Actual Study Start Date : March 2015
Actual Primary Completion Date : March 15, 2018
Actual Study Completion Date : March 15, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Change from baseline asthma knowledge to immediately post-intervention, 2 months, 4 months, and 6 months [ Time Frame: Baseline, immediately post-intervention, 2 months, 4 months, 6 months ]
    Asthma knowledge as measured by the validated Asthma Knowledge Questionnaire

  2. Patient satisfaction measured by the Client Satisfaction Questionnaire-8 [ Time Frame: Immediately post-intervention at the baseline visit, 2 months, 4 months, 6 months ]
    Patient satisfaction measured by the Client Satisfaction Questionnaire-8

  3. Time spent in using the mobile application [ Time Frame: Immediately post-intervention at the baseline visit ]
    Time spent in using the mobile application

  4. Asthma quality of life measured by the mini-Asthma Quality of Life Questionnaire (mini-AQLQ) [ Time Frame: Baseline, 2 months, 4 months, 6 months ]
    Patients' asthma quality of life measured by the mini-Asthma Quality of Life Questionnaire (mini-AQLQ)

  5. Asthma emergency department visits [ Time Frame: Baseline, 2 months, 4 months, 6 months ]
    Asthma emergency department visits

  6. Asthma hospitalizations [ Time Frame: Baseline, 2 months, 4 months, 6 months ]
    Asthma hospitalizations

  7. Asthma-related steroid courses [ Time Frame: Baseline, 2 months, 4 months, 6 months ]
    Asthma-related steroid courses


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03518879


Locations
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United States, New York
Montefiore Medical Center
Bronx, New York, United States, 10467
Sponsors and Collaborators
Montefiore Medical Center
Investigators
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Principal Investigator: Sunit Jariwala Montefiore Medical Center
More Information
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Responsible Party: Sunit P. Jariwala, Associate Professor (Medicine), Montefiore Medical Center
ClinicalTrials.gov Identifier: NCT03518879    
Other Study ID Numbers: 2013-2693
First Posted: May 8, 2018    Key Record Dates
Last Update Posted: May 16, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: The investigators will share de-identified and aggregated study findings.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sunit P. Jariwala, Montefiore Medical Center:
informatics
asthma
Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
 Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases