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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00136305
Other study ID # 04 08-102E
Secondary ID KBR 01.4182
Status Terminated
Phase Phase 2
First received
Last updated
Start date August 2005

Study information

Verified date August 2021
Source Children's Mercy Hospital Kansas City
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Terminated
Enrollment 4
Est. completion date
Est. primary completion date May 2006
Accepts healthy volunteers No
Gender All
Age group 6 Years to 18 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Pictorial asthma action plan

Written asthma action plan


Locations

Country Name City State
United States The Children's Mercy Hospitals and Clinics Kansas City Missouri

Sponsors (2)

Lead Sponsor Collaborator
Children's Mercy Hospital Kansas City Katherine B. Anderson Associates Endowment Fund

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Scores on the Asthma Action Plan Knowledge Interview Measures recall of asthma treatment plan 1 month
Secondary Adherence to Controller Medication Mean daily adherence to medication measured via electronic monitoring 1 month
Secondary Rescue Medication Use Number of puffs of inhaled rescue medication 1 month
Secondary Family satisfaction survey scores Family ratings of satisfaction with asthma action plan 1 month
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