A Computer-Based ED Intervention to Improve Pediatric Asthma Medicine Adherence

NCT ID: NCT02787174

Last Updated: 2020-03-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

109 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-02-29

Study Completion Date

2018-07-31

Brief Summary

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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.

Detailed Description

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The investigators have used focus groups to get ideas from parents of children with asthma to best design the intervention. This has helped us create the questions that are being used in the intervention, and make the computer program appealing and acceptable to parents of children with asthma.

The investigators will study the success of the intervention for children who receive it compared to children who obtain routine emergency department care. Participants who receive the intervention will complete a series of questions on a tablet computer. Questions will guide creation of individualized education and advice to improve medication use for each participant. The intervention will also allow for customized communication with each child's primary care provider. The investigators will include educational boosters at 2 and 4 weeks after the intervention delivered as chosen by the participant (email / text / RSS / mail). Children in the routine asthma care arm will not receive the intervention, and instead will receive routine discharge instructions by the emergency room doctors.

The investigators will compare the success of the intervention group to routine emergency department care by using a device (DOSER CT) that measures daily administered doses of medicine. Data from the DOSER CT will be collected monthly at home visits for three months. The investigators will also measure health care use and quality-of-life for each child using a survey at these home visits. The investigators believe that the intervention will improve doses of medicine given, reduce unnecessary health care use, and improve children's quality of life.

Conditions

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Asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Investigators

Study Groups

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Control

Participants will receive routine clinical treatment care.

Group Type NO_INTERVENTION

No interventions assigned to this group

Intervention

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

Group Type EXPERIMENTAL

Asthma Medication Adherence Education

Intervention Type OTHER

Interventions

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Asthma Medication Adherence Education

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Parent does not speak English
* Child is prescribed inhaled corticosteroid seasonally
* Patient is on a combination inhaled corticosteroid controller asthma med
Minimum Eligible Age

2 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role collaborator

Rhode Island Hospital

OTHER

Sponsor Role lead

Responsible Party

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Aris Garro

Physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Hasbro Children's Hospital

Providence, Rhode Island, United States

Site Status

Countries

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United States

Other Identifiers

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R21HD082621

Identifier Type: NIH

Identifier Source: secondary_id

View Link

629210

Identifier Type: -

Identifier Source: org_study_id

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