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Comparing Asthma Action Plans for Pediatric Asthma

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: NCT00136305
Recruitment Status : Terminated (PI moved to a different institution)
First Posted : August 29, 2005
Last Update Posted : February 4, 2015
Information provided by (Responsible Party):

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Asthma Behavioral: Pictorial asthma action plan Behavioral: Written asthma action plan Phase 2

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Relative Effectiveness of Pictorial and Written Asthma Action Plans for Pediatric Asthma
Study Start Date : August 2005
Primary Completion Date : May 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
U.S. FDA Resources

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :
  1. Scores on the Asthma Action Plan Knowledge Interview [ Time Frame: 1 month ]
    Measures recall of asthma treatment plan

Secondary Outcome Measures :
  1. Adherence to Controller Medication [ Time Frame: 1 month ]
    Mean daily adherence to medication measured via electronic monitoring

  2. Rescue Medication Use [ Time Frame: 1 month ]
    Number of puffs of inhaled rescue medication

  3. Family satisfaction survey scores [ Time Frame: 1 month ]
    Family ratings of satisfaction with asthma action plan

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Contacts and Locations

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): NCT00136305

United States, Missouri
The Children's Mercy Hospitals and Clinics
Kansas City, Missouri, United States, 64108
Sponsors and Collaborators
Children's Mercy Hospital Kansas City
Katherine B. Anderson Associates Endowment Fund
Principal Investigator: Christina D Adams, PhD The Children's Mercy Hospitals and Clinics
More Information

Responsible Party: Christina L Duncan, PhD, Clinical Psychologist & Associate Professor, Children's Mercy Hospital Kansas City
ClinicalTrials.gov Identifier: NCT00136305     History of Changes
Other Study ID Numbers: 04 08-102E
KBR 01.4182
First Posted: August 29, 2005    Key Record Dates
Last Update Posted: February 4, 2015
Last Verified: February 2015

Keywords provided by Christina L Duncan, PhD, Children's Mercy Hospital Kansas City:
pediatric asthma
asthma action plans
patient education
medication adherence

Additional relevant MeSH terms:
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases