Comparing Asthma Action Plans for Pediatric Asthma

Sponsor
Children's Mercy Hospital Kansas City (Other)
Overall Status
Terminated
CT.gov ID
NCT00136305
Collaborator
Katherine B. Anderson Associates Endowment Fund (Other)
4
1
2

Study Details

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
  • 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
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 :
Aug 1, 2005
Actual Primary Completion Date :
May 1, 2006

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 [1 month]

    Measures recall of asthma treatment plan

Secondary Outcome Measures

  1. Adherence to Controller Medication [1 month]

    Mean daily adherence to medication measured via electronic monitoring

  2. Rescue Medication Use [1 month]

    Number of puffs of inhaled rescue medication

  3. Family satisfaction survey scores [1 month]

    Family ratings of satisfaction with asthma action plan

Eligibility Criteria

Criteria

Ages Eligible for Study:
6 Years to 18 Years
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

Locations

Site City State Country Postal Code
1 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

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Children's Mercy Hospital Kansas City
ClinicalTrials.gov Identifier:
NCT00136305
Other Study ID Numbers:
  • 04 08-102E
  • KBR 01.4182
First Posted:
Aug 29, 2005
Last Update Posted:
Aug 26, 2021
Last Verified:
Aug 1, 2021
Keywords provided by Children's Mercy Hospital Kansas City
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 26, 2021