NCT03518879

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P25-P50 for not_applicable asthma

Timeline
Completed

Started Mar 2015

Longer than P75 for not_applicable asthma

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2015

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

April 13, 2018

Completed
25 days until next milestone

First Posted

Study publicly available on registry

May 8, 2018

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2021

Completed
Last Updated

June 7, 2023

Status Verified

June 1, 2023

Enrollment Period

6.3 years

First QC Date

April 13, 2018

Last Update Submit

June 6, 2023

Conditions

Asthma

Keywords

informaticsasthma

Outcome Measures

Primary Outcomes (1)

  • Change from baseline asthma control to 2, 4, and 6 months

    Asthma symptom burden as measured by the Asthma Control Test

    Baseline, 2 months, 4 months, 6 months

Secondary Outcomes (7)

  • Change from baseline asthma knowledge to immediately post-intervention, 2 months, 4 months, and 6 months

    Baseline, immediately post-intervention, 2 months, 4 months, 6 months

  • Patient satisfaction measured by the Client Satisfaction Questionnaire-8

    Immediately post-intervention at the baseline visit, 2 months, 4 months, 6 months

  • Time spent in using the mobile application

    Immediately post-intervention at the baseline visit

  • Asthma quality of life measured by the mini-Asthma Quality of Life Questionnaire (mini-AQLQ)

    Baseline, 2 months, 4 months, 6 months

  • Asthma emergency department visits

    Baseline, 2 months, 4 months, 6 months

  • +2 more secondary outcomes

Study Arms (1)

ASTHMA-Educator arm

EXPERIMENTAL

The ASTHMA-Educator mobile application for patient-centered asthma education. The application is administered via on-site iPad (tablet).

Other: ASTHMA-Educator mobile application

Interventions

ASTHMA-Educator mobile applicationOTHER

The on-site delivered ASTHMA-Educator mobile application.

ASTHMA-Educator arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Sunit Jariwala

    Montefiore Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Model Details: This is a single-arm proof of concept study to evaluate the impact of the ASTHMA-Educator on process and clinical outcomes
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 13, 2018

First Posted

May 8, 2018

Study Start

March 1, 2015

Primary Completion

July 1, 2021

Study Completion

July 1, 2021

Last Updated

June 7, 2023

Record last verified: 2023-06

Locations

US(1)