NCT00133666

Brief Summary

The purpose of this study is to determine if teaching children with asthma how to talk to their doctor about controlling their asthma including symptom frequency in an asthma diary and medication use techniques, will result in less symptom and missed school days, fewer emergency room visits and reduce the cost of asthma health care.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
231

participants targeted

Target at P75+ for phase_2 asthma

Timeline
Completed

Started Sep 2004

Longer than P75 for phase_2 asthma

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2004

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

August 19, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 23, 2005

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2008

Completed
Last Updated

July 17, 2008

Status Verified

July 1, 2008

Enrollment Period

3.7 years

First QC Date

August 19, 2005

Last Update Submit

July 16, 2008

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

  • Reduce the cost of asthma health care.

    18 Months

Secondary Outcomes (3)

  • Fewer emergency room visits

    18 Months

  • Less symptoms

    18 Months

  • Fewer missed school days

    18 Months

Study Arms (2)

1

EXPERIMENTAL
Behavioral: Asthma Communication Education

2

ACTIVE COMPARATOR
Behavioral: Standard Asthma Education

Interventions

Asthma Communication EducationBEHAVIORAL
1
Standard Asthma EducationBEHAVIORAL
2

Eligibility Criteria

Age6 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Age 6-12 years
  • Physician diagnosis of asthma
  • Reside in metropolitan Baltimore
  • English speaking
  • Able to read 80% of parent educational brochure in English
  • Emergency Department (ED) visit within the past 12 months and can identify a primary care provider
  • No other co-morbid pulmonary disease

You may not qualify if:

  • Enrolled in another asthma study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johns Hopkins University

Baltimore, Maryland, 21287, United States

Location

Related Publications (2)

  • Logan J and Butz AM. Improving asthma communication in minority families - ongoing pilot study. Am J Respir and Crit Care Med. 2004; Abstract No. 5119, American Thoracic Society International Meeting, Orlando, FL, May 2004. Butz AM. Effective asthma communication: Children and primary care providers. European Respiratory Society Annual Congress. September 2004, Glasgow, Scotland.

    BACKGROUND

  • Butz A, Kub J, Donithan M, James NT, Thompson RE, Bellin M, Tsoukleris M, Bollinger ME. Influence of caregiver and provider communication on symptom days and medication use for inner-city children with asthma. J Asthma. 2010 May;47(4):478-85. doi: 10.3109/02770901003692793.

    PMID: 20528605DERIVED

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Arlene Butz, SCD,MSN,BSN

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Intervention Model
PARALLEL
Sponsor Type
NIH

Study Record Dates

First Submitted

August 19, 2005

First Posted

August 23, 2005

Study Start

September 1, 2004

Primary Completion

May 1, 2008

Study Completion

May 1, 2008

Last Updated

July 17, 2008

Record last verified: 2008-07

Locations

US(1)