NCT00832923

Brief Summary

The overall aim of this study will be to perform a prospective randomized clinical trial of an enhanced version of the IMPACT DC intervention involving short-term case management to facilitate PCP follow-up appointments and to provide education for parents about how to communicate more effectively with their children's PCPs as a means (1) to improve the rate of utilization of primary care services for ongoing asthma care and (2) to enhance the self-efficacy of parents in their interactions with their children's provider regarding the child's asthma care needs in 150 parents of high risk children referred within the IMPACT DC Asthma Clinic.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
150

participants targeted

Target at P50-P75 for not_applicable asthma

Timeline
Completed

Started Jan 2009

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

January 1, 2009

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

January 29, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 30, 2009

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

September 12, 2014

Status Verified

September 1, 2014

Enrollment Period

2.9 years

First QC Date

January 29, 2009

Last Update Submit

September 10, 2014

Conditions

Keywords

parental empowermentparent self-efficacy

Outcome Measures

Primary Outcomes (1)

  • Utilization of Primary Care Provider

    2 months & 6 months after visit

Secondary Outcomes (1)

  • Parental Self-efficacy in communicating about Asthma care with child's primary care provider

    2 months & 6 months after visit

Study Arms (2)

Routine IMPACT DC care

NO INTERVENTION

Participants receive standard asthma education as routine for IMPACT DC

Enhanced care PEPAC Intervention

EXPERIMENTAL
Behavioral: PEPAC

Interventions

PEPACBEHAVIORAL

The proposed enhancement of the IMPACT DC intervention will consist of three key components: (1) an enhanced IMPACT DC Asthma Clinic visit; (2) short-term case management to increase the rate of primary care follow-up visits in the first month after the IMPACT DC Asthma Clinic visit; and (3) training in an "asthma care toolkit" to improve communication around asthma care with the child's primary care provider.

Enhanced care PEPAC Intervention

Eligibility Criteria

Age12 Months - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • ages between 12 months and 12 years, inclusive
  • prior physician diagnosed asthma
  • ability of the parent to identify a specific PCP for their child
  • public insurance covering the child
  • parent/guardian available for interview

You may not qualify if:

  • significant medical co-morbidities
  • enrollment in another asthma research intervention study
  • unavailability for telephone follow-up
  • primary language of the caregiver other than English

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Research Institute

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

Location

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief, Division of Allergy and Immunology

Study Record Dates

First Submitted

January 29, 2009

First Posted

January 30, 2009

Study Start

January 1, 2009

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

September 12, 2014

Record last verified: 2014-09

Locations