Comparing Asthma Action Plans for Pediatric Asthma

August 20, 2021 updated by: Children's Mercy Hospital Kansas City

Relative Effectiveness of Pictorial and Written Asthma Action Plans for Pediatric Asthma

The purpose of this study is to evaluate and compare the relative effectiveness of two asthma action plans (pictorial versus written) in terms of asthma action plan knowledge, medication use, and family satisfaction with asthma education.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Asthma medical regimens are complex for families, requiring changes in the types and amounts of medication based on the frequency and intensity of symptoms. Written asthma action plans (AAP's) are commonly used to provide a set of instructions to help parents and children implement these complicated regimens. However, written AAP's require substantial literacy levels, so for younger children, low-literacy families, or non-English speaking families, a pictorial version of the AAP may be more understandable and useful. The study aims to validate a newly developed, fully pictorial AAP in terms of its relative impact on parent- and child-reported knowledge of the action plan, medication use, and parent- and child-reported satisfaction, when compared to a standard-care written AAP.

Study Type

Interventional

Enrollment (Actual)

4

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • Kansas City, Missouri, United States, 64108
        • The Children's Mercy Hospitals and Clinics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Children who are new patients
  • Receive a diagnosis of persistent asthma
  • Are in need of an asthma action plan

Exclusion Criteria:

  • Diagnosed with intermittent asthma
  • An established patient who already has an asthma action plan
  • Not English or Spanish speaking

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Pictorial Asthma Action Plan
Behavioral: Pictorial asthma action plan
Active Comparator: Written Asthma Action Plan
Behavioral: Written asthma action plan

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Scores on the Asthma Action Plan Knowledge Interview
Time Frame: 1 month
Measures recall of asthma treatment plan
1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adherence to Controller Medication
Time Frame: 1 month
Mean daily adherence to medication measured via electronic monitoring
1 month
Rescue Medication Use
Time Frame: 1 month
Number of puffs of inhaled rescue medication
1 month
Family satisfaction survey scores
Time Frame: 1 month
Family ratings of satisfaction with asthma action plan
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Children's Mercy Hospital Kansas City

Collaborators

Katherine B. Anderson Associates Endowment Fund

Investigators

  • Principal Investigator: Christina D Adams, PhD, The Children's Mercy Hospitals and Clinics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2005

Primary Completion (Actual)

May 1, 2006

Study Registration Dates

First Submitted

August 26, 2005

First Submitted That Met QC Criteria

August 26, 2005

First Posted (Estimate)

August 29, 2005

Study Record Updates

Last Update Posted (Actual)

August 26, 2021

Last Update Submitted That Met QC Criteria

August 20, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 04 08-102E
  • KBR 01.4182

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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