NCT03036982

Brief Summary

This study will assess whether adaption of the Asthma Control Test (ACT) and childhood Asthma Control Test (cACT) for mobile devices improves rate of completion and improves control of asthma in children and adolescents

Trial Health

87
On Track

Trial Health Score

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

Enrollment
221

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2016

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

First Submitted

Initial submission to the registry

July 27, 2015

Completed
5 months until next milestone

Study Start

First participant enrolled

January 1, 2016

Completed
1.1 years until next milestone

First Posted

Study publicly available on registry

January 31, 2017

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2017

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2017

Completed
Last Updated

March 27, 2018

Status Verified

March 1, 2018

Enrollment Period

1.3 years

First QC Date

July 27, 2015

Last Update Submit

March 26, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • Well-controlled asthma

    Percent of ACT scores with value of 20 or greater

    Each month for one calendar year

Secondary Outcomes (1)

  • Asthma Emergency Department visits and hospitalizations

    Total Emergency Department Visits and hospitalizations with asthma as one of top diagnosis in one year

Study Arms (1)

Use of Mobile ACT

Will answer ACT (or cACT) and other asthma questions using mobile app

Eligibility Criteria

Age4 Years - 21 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Patients with asthma seen in one of the clinics caring for patients with asthma at Boston Children's Hospital Age 4-21

You may qualify if:

  • Diagnosis of asthma
  • Cared for at Boston Children's Hospital (Primary or secondary care)

You may not qualify if:

  • Age \<4 or \>21

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Boston Childrens Hospital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

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

Study Officials

  • Andrew MacGinnitie, MD PhD

    Boston Children's Hosptial

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Clinical Director, Division of Immunology

Study Record Dates

First Submitted

July 27, 2015

First Posted

January 31, 2017

Study Start

January 1, 2016

Primary Completion

April 30, 2017

Study Completion

December 31, 2017

Last Updated

March 27, 2018

Record last verified: 2018-03

Data Sharing

IPD Sharing
Will share

Will make deidentified data available for other researchers

Locations