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Completed

NCT Number: NCT03518879

ASTHMA-Educator Mobile Application Manage Asthma

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Montefiore Medical Center

The Bronx, New York, 10467, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ASTHMA-Educator mobile application

Other

The on-site delivered ASTHMA-Educator mobile application.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Montefiore Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2021
Study completion
2021
First posted
May 8, 2018
Registry last updated
Jun 7, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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