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Pediatric ASTHMA-Educator

Primary Purpose

Asthma

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Pediatric ASTHMA-Educator mobile application
Sponsored by
Montefiore Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Asthma focused on measuring asthma

Eligibility Criteria

7 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Montefiore Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Pediatric ASTHMA-Educator arm

Arm Description

This arm corresponds to the pediatric version of the ASTHMA-Educator mobile application.

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

Patient satisfaction measured by the Client Satisfaction Questionnaire-8
Patient satisfaction measured by the Client Satisfaction Questionnaire-8
Change from baseline asthma knowledge to 2 months, 4 months, 6 months
Asthma knowledge as measured by the Asthma Knowledge Questionnaire
Asthma quality of life as measured by the Pediatric Asthma Impact Scale
Patient's asthma quality of life measured by the Pediatric Asthma Impact Scale
Self-reported medication adherence
Patients' self-reported medication adherence measured by the Medication Adherence Rating Scale
Asthma emergency department visits
Asthma emergency department visits
Asthma hospitalizations
Asthma hospitalizations
Asthma-related steroid courses
Asthma-related steroid courses

Full Information

First Posted
April 13, 2018
Last Updated
June 7, 2023
Sponsor
Montefiore Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT03520881
Brief Title
Pediatric ASTHMA-Educator
Official Title
The Development and Pilot Testing of a Pediatric Algorithmic Software Tool to Help Manage Asthma (ASTHMA)-Educator
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
July 1, 2016 (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
This project seeks to develop and pilot test the pediatric ASTHMA-Educator mobile application.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
asthma

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
There is one group (intervention arm only) in this proof of concept study.
Masking
None (Open Label)
Allocation
N/A
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pediatric ASTHMA-Educator arm
Arm Type
Experimental
Arm Description
This arm corresponds to the pediatric version of the ASTHMA-Educator mobile application.
Intervention Type
Other
Intervention Name(s)
Pediatric ASTHMA-Educator mobile application
Intervention Description
This intervention represents a mobile application (accessible by iOS and Android devices) that provides asthma education through games and videos.
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
Patient satisfaction measured by the Client Satisfaction Questionnaire-8
Description
Patient satisfaction measured by the Client Satisfaction Questionnaire-8
Time Frame
Baseline, 2 months, 4 months, 6 months
Title
Change from baseline asthma knowledge to 2 months, 4 months, 6 months
Description
Asthma knowledge as measured by the Asthma Knowledge Questionnaire
Time Frame
Baseline, 2 months, 4 months, 6 months
Title
Asthma quality of life as measured by the Pediatric Asthma Impact Scale
Description
Patient's asthma quality of life measured by the Pediatric Asthma Impact Scale
Time Frame
Baseline, 2 months, 4 months, 6 months
Title
Self-reported medication adherence
Description
Patients' self-reported medication adherence measured by the Medication Adherence Rating Scale
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
7 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sunit Jariwala, MD
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
Yes
IPD Sharing Plan Description
We will share aggregated and deidentified data in the form of abstracts and publications.

Learn more about this trial

Pediatric ASTHMA-Educator

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