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

Primary Purpose

Asthma

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Asthma Medication Adherence Education
Sponsored by
Rhode Island Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Asthma focused on measuring Asthma, Medication adherence, Intervention study

Eligibility Criteria

2 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hasbro Children's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control

Intervention

Arm Description

Participants will receive routine clinical treatment care.

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Unscheduled healthcare use (self-report survey and chart review)
Unscheduled healthcare use (Emergency Department visits, doctor visits, hospitalizations)
Quality-of-Life (QOL)
QOL measurement using Integrated Therapeutics Group Child Asthma Short Form (ITG-CASF)
Sustained Asthma controller medication adherence
Percentage adherent days defined as at least half of prescribed doses taken as measured by Doser CT

Full Information

First Posted
May 19, 2016
Last Updated
March 9, 2020
Sponsor
Rhode Island Hospital
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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1. Study Identification

Unique Protocol Identification Number
NCT02787174
Brief Title
A Computer-Based ED Intervention to Improve Pediatric Asthma Medicine Adherence
Acronym
ED-AMAP
Official Title
A Computer-Based ED Intervention to Improve Pediatric Asthma Medicine Adherence
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
February 2016 (Actual)
Primary Completion Date
January 2018 (Actual)
Study Completion Date
July 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rhode Island Hospital
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

4. Oversight

5. Study Description

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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
Asthma, Medication adherence, Intervention study

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
109 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
Participants will receive routine clinical treatment care.
Arm Title
Intervention
Arm Type
Experimental
Arm Description
Participants will receive interactive tailored asthma medication adherence education on an iPad.
Intervention Type
Other
Intervention Name(s)
Asthma Medication Adherence Education
Primary Outcome Measure Information:
Title
Asthma controller medication adherence
Description
Percentage adherent days defined as at least half of prescribed doses taken as measured by Doser CT
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Unscheduled healthcare use (self-report survey and chart review)
Description
Unscheduled healthcare use (Emergency Department visits, doctor visits, hospitalizations)
Time Frame
6 months
Title
Quality-of-Life (QOL)
Description
QOL measurement using Integrated Therapeutics Group Child Asthma Short Form (ITG-CASF)
Time Frame
6 months
Title
Sustained Asthma controller medication adherence
Description
Percentage adherent days defined as at least half of prescribed doses taken as measured by Doser CT
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Hasbro Children's Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02905
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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