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

Asthma Clinical Trial

— ED-AMAP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02787174
• Other study ID #: 629210
• Secondary ID: R21HD082621
• Status: Completed
• Phase: N/A
• Start date: February 2016
• Est. completion date: July 2018

Study information

• Verified date: March 2020
• Source: Rhode Island Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 109
• Est. completion date: July 2018
• Est. primary completion date: January 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Asthma

Intervention

Other:
• Asthma Medication Adherence Education

Locations

Country	Name	City	State
United States	Hasbro Children's Hospital	Providence	Rhode Island

Sponsors (2)

Lead Sponsor	Collaborator
Rhode Island Hospital	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Asthma controller medication adherence	Percentage adherent days defined as at least half of prescribed doses taken as measured by Doser CT	12 weeks
Secondary	Unscheduled healthcare use (self-report survey and chart review)	Unscheduled healthcare use (Emergency Department visits, doctor visits, hospitalizations)	6 months
Secondary	Quality-of-Life (QOL)	QOL measurement using Integrated Therapeutics Group Child Asthma Short Form (ITG-CASF)	6 months
Secondary	Sustained Asthma controller medication adherence	Percentage adherent days defined as at least half of prescribed doses taken as measured by Doser CT	3 months