NCT00140439

Brief Summary

Little is known about how ED-based programs can help to reduce pediatric ED visits for asthma. The current study evaluated a novel intervention in which the ED itself became the site of highly individualized, comprehensive follow-up asthma care. It sought to determine if such an intervention could decrease subsequent unscheduled visits for asthma while improving asthma quality of life.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
488

participants targeted

Target at P75+ for not_applicable asthma

Timeline
Completed

Started Apr 2002

Typical duration for not_applicable 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

April 1, 2002

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2005

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 31, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 1, 2005

Completed
Last Updated

August 25, 2015

Status Verified

August 1, 2015

Enrollment Period

3.2 years

First QC Date

August 31, 2005

Last Update Submit

August 21, 2015

Conditions

Keywords

asthmaemergency departmentcompliancerandomized clinical trial

Outcome Measures

Primary Outcomes (1)

  • Unscheduled visits for asthma

    6 months following enrollment

Secondary Outcomes (4)

  • Hospitalizations for asthma

    6 months following enrollment

  • Compliance

    6 months following enrollment

  • Quality of Life

    6 months following enrollment

  • Morbidity

    6 months following enrollment

Interventions

The clinical activities of the intervention followed a fully specified protocol and provided education and care in three domains: 1. Asthma self-monitoring and management: Educators first reviewed the basic physiology of asthma with emphasis on its chronicity. After evaluating asthma severity and treatment history, the physician completed an individualized medical action plan (MAP) and provided any necessary device teaching. 2. Environmental modification and trigger control: After evaluation of potential environmental triggers in the home, each family was educated on their control. Each child was provided hypoallergenic bed encasings. 3. Linkages and referrals to ongoing primary care: Clinic staff stressed the importance of longitudinal asthma care by a PCP. A full report of the clinic visit was mailed to each child's PCP. In addition, the asthma educator scheduled a follow-up appointment with the PCP within 4 weeks

Eligibility Criteria

Age12 Months - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • age between 12 months and 17 years, inclusive;
  • prior physician-diagnosed asthma;
  • ≥1 other unscheduled visit for asthma in the previous 6 months and/or ≥1 hospitalization for asthma in the prior 12 months;
  • a parent/guardian available for interview;
  • residence in Washington, DC or a contiguous Maryland county; and
  • requirement for ≥3 doses of nebulized albuterol in the ED at the time of enrollment.

You may not qualify if:

  • significant medical co-morbidities affecting the cardiorespiratory system;
  • a visit to an allergist or a pulmonologist in the prior 6 months;
  • ≥2 of the following: a current written asthma medical action plan, current use of \>1 controller medication, or a scheduled visit for asthma care with their PCP in the prior two weeks;
  • enrollment in another asthma research study;
  • unavailability for telephone follow-up; or
  • primary language other than English or Spanish.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's National Medical Center

Washington D.C., District of Columbia, 20010, United States

Location

MeSH Terms

Conditions

AsthmaEmergenciesPatient Compliance

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsPatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Stephen J Teach, MD

    Children's National Research Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

August 31, 2005

First Posted

September 1, 2005

Study Start

April 1, 2002

Primary Completion

June 1, 2005

Study Completion

June 1, 2005

Last Updated

August 25, 2015

Record last verified: 2015-08

Locations