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Completed

NCT Number: NCT03520881

Pediatric ASTHMA-Educator

This project seeks to develop and pilot test the pediatric ASTHMA-Educator mobile application.

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Key information

Age range

7 year–17 year

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

This project seeks to develop and pilot test the pediatric ASTHMA-Educator mobile application. The study is being conducted at Montefiore Medical Center among pediatric (7-17 years old) patients with persistent asthma. We are collecting process and clinical outcomes in a longitudinal study design.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

English-speaking individuals between 7-17 years with:

  • Persistent asthma (diagnosis made by a healthcare provider) on a daily controller medication
  • Able to give informed consent
  • Smartphone (iOS or Android) access

Exclusion criteria

  • Use of oral corticosteroids in the 2 weeks prior to the baseline visit
  • Pregnancy
  • Severe psychiatric or cognitive problems that would prohibit an individual from understanding and completing the protocol
  • Patients that previously received the ASTHMA-Educator application

Treatment and study plan

Pediatric ASTHMA-Educator mobile application

Other

This intervention represents a mobile application (accessible by iOS and Android devices) that provides asthma education through games and videos.

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. Patient satisfaction measured by the Client Satisfaction Questionnaire-8

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

    Patient satisfaction measured by the Client Satisfaction Questionnaire-8

  2. Change from baseline asthma knowledge to 2 months, 4 months, 6 months

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

    Asthma knowledge as measured by the Asthma Knowledge Questionnaire

  3. Asthma quality of life as measured by the Pediatric Asthma Impact Scale

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

    Patient's asthma quality of life measured by the Pediatric Asthma Impact Scale

  4. Self-reported medication adherence

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

    Patients' self-reported medication adherence measured by the Medication Adherence Rating Scale

  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 Development and Pilot Testing of a Pediatric Algorithmic Software Tool to Help Manage Asthma (ASTHMA)-Educator

Important dates

Study start
2016
Primary completion
2021
Study completion
2021
First posted
May 11, 2018
Registry last updated
Jun 8, 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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