NCT02787174

Brief Summary

Asthma is common in children and impacts their health. There are effective medications for improving asthma, but some families have difficulty using medicines on a regular basis. This study in the emergency department will improve medicine use for children 2-12 years-old with asthma by developing content for a customized, tablet-based electronic intervention. A clinical trial will then be used to compare asthma outcomes for this intervention with routine asthma care.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
109

participants targeted

Target at P50-P75 for not_applicable asthma

Timeline
Completed

Started Feb 2016

Typical duration 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

February 1, 2016

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 19, 2016

Completed
13 days until next milestone

First Posted

Study publicly available on registry

June 1, 2016

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2018

Completed
Last Updated

March 10, 2020

Status Verified

March 1, 2020

Enrollment Period

1.9 years

First QC Date

May 19, 2016

Last Update Submit

March 9, 2020

Conditions

Asthma

Keywords

AsthmaMedication adherenceIntervention study

Outcome Measures

Primary Outcomes (1)

  • Asthma controller medication adherence

    Percentage adherent days defined as at least half of prescribed doses taken as measured by Doser CT

    12 weeks

Secondary Outcomes (3)

  • Unscheduled healthcare use (self-report survey and chart review)

    6 months

  • Quality-of-Life (QOL)

    6 months

  • Sustained Asthma controller medication adherence

    3 months

Study Arms (2)

Control

NO INTERVENTION

Participants will receive routine clinical treatment care.

Intervention

EXPERIMENTAL

Participants will receive interactive tailored asthma medication adherence education on an iPad.

Other: Asthma Medication Adherence Education

Interventions

Asthma Medication Adherence EducationOTHER
Intervention

Eligibility Criteria

Age2 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Asthma diagnosis by physician or parent report
  • Ages 2-12
  • Prescribed an inhaled corticosteroid asthma controller medicine

You may not qualify if:

  • Parent does not speak English
  • Child is prescribed inhaled corticosteroid seasonally
  • Patient is on a combination inhaled corticosteroid controller asthma med

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hasbro Children's Hospital

Providence, Rhode Island, 02905, United States

Location

MeSH Terms

Conditions

AsthmaMedication Adherence

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System DiseasesPatient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physician

Study Record Dates

First Submitted

May 19, 2016

First Posted

June 1, 2016

Study Start

February 1, 2016

Primary Completion

January 1, 2018

Study Completion

July 1, 2018

Last Updated

March 10, 2020

Record last verified: 2020-03

Locations

US(1)