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Completed

NCT Number: NCT02787174

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

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.

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Key information

Conditions

Asthma Behavior Bronchial Diseases Health Behavior Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Medication Adherence Patient Acceptance of Health Care Patient Compliance Respiratory Hypersensitivity Respiratory Tract Diseases Treatment Adherence and Compliance

Age range

2 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hasbro Children's Hospital

Providence, Rhode Island, 02905, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Asthma Medication Adherence Education

Other

Primary outcomes

  1. Asthma controller medication adherence

    Time frame: 12 weeks

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

Secondary outcomes

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

    Time frame: 6 months

    Unscheduled healthcare use (Emergency Department visits, doctor visits, hospitalizations)

  2. Quality-of-Life (QOL)

    Time frame: 6 months

    QOL measurement using Integrated Therapeutics Group Child Asthma Short Form (ITG-CASF)

  3. Sustained Asthma controller medication adherence

    Time frame: 3 months

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

Sponsors and collaborators

Lead sponsor

Rhode Island Hospital

Other

Collaborators

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

Registry information

Acronym: ED-AMAP

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Jun 1, 2016
Registry last updated
Mar 10, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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