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Comparing Asthma Action Plans for Pediatric Asthma

Primary Purpose

Asthma

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Pictorial asthma action plan
Written asthma action plan
Sponsored by
Children's Mercy Hospital Kansas City
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma focused on measuring pediatric asthma, asthma action plans, patient education, medication adherence

Eligibility Criteria

6 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The Children's Mercy Hospitals and Clinics

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Pictorial Asthma Action Plan

Written Asthma Action Plan

Arm Description

Outcomes

Primary Outcome Measures

Scores on the Asthma Action Plan Knowledge Interview
Measures recall of asthma treatment plan

Secondary Outcome Measures

Adherence to Controller Medication
Mean daily adherence to medication measured via electronic monitoring
Rescue Medication Use
Number of puffs of inhaled rescue medication
Family satisfaction survey scores
Family ratings of satisfaction with asthma action plan

Full Information

First Posted
August 26, 2005
Last Updated
August 20, 2021
Sponsor
Children's Mercy Hospital Kansas City
Collaborators
Katherine B. Anderson Associates Endowment Fund
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1. Study Identification

Unique Protocol Identification Number
NCT00136305
Brief Title
Comparing Asthma Action Plans for Pediatric Asthma
Official Title
Relative Effectiveness of Pictorial and Written Asthma Action Plans for Pediatric Asthma
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Terminated
Why Stopped
PI moved to a different institution
Study Start Date
August 2005 (undefined)
Primary Completion Date
May 2006 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Children's Mercy Hospital Kansas City
Collaborators
Katherine B. Anderson Associates Endowment Fund

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
pediatric asthma, asthma action plans, patient education, medication adherence

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
4 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pictorial Asthma Action Plan
Arm Type
Experimental
Arm Title
Written Asthma Action Plan
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Pictorial asthma action plan
Intervention Type
Behavioral
Intervention Name(s)
Written asthma action plan
Primary Outcome Measure Information:
Title
Scores on the Asthma Action Plan Knowledge Interview
Description
Measures recall of asthma treatment plan
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Adherence to Controller Medication
Description
Mean daily adherence to medication measured via electronic monitoring
Time Frame
1 month
Title
Rescue Medication Use
Description
Number of puffs of inhaled rescue medication
Time Frame
1 month
Title
Family satisfaction survey scores
Description
Family ratings of satisfaction with asthma action plan
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christina D Adams, PhD
Organizational Affiliation
The Children's Mercy Hospitals and Clinics
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Children's Mercy Hospitals and Clinics
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64108
Country
United States

12. IPD Sharing Statement

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Comparing Asthma Action Plans for Pediatric Asthma

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