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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02787174
Recruitment Status : Completed
First Posted : June 1, 2016
Last Update Posted : March 10, 2020
Sponsor:
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Aris Garro, Rhode Island Hospital

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.

Condition or disease Intervention/treatment Phase
Asthma Other: Asthma Medication Adherence Education Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 109 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Other
Official Title: A Computer-Based ED Intervention to Improve Pediatric Asthma Medicine Adherence
Actual Study Start Date : February 2016
Actual Primary Completion Date : January 2018
Actual Study Completion Date : July 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arm Intervention/treatment
No Intervention: Control
Participants will receive routine clinical treatment care.
Experimental: Intervention
Participants will receive interactive tailored asthma medication adherence education on an iPad.
Other: Asthma Medication Adherence Education



Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02787174


Locations
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United States, Rhode Island
Hasbro Children's Hospital
Providence, Rhode Island, United States, 02905
Sponsors and Collaborators
Rhode Island Hospital
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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Responsible Party: Aris Garro, Physician, Rhode Island Hospital
ClinicalTrials.gov Identifier: NCT02787174    
Other Study ID Numbers: 629210
R21HD082621 ( U.S. NIH Grant/Contract )
First Posted: June 1, 2016    Key Record Dates
Last Update Posted: March 10, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Aris Garro, Rhode Island Hospital:
Asthma
Medication adherence
Intervention study
Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases