NCT00424125

Brief Summary

This study seeks to determine whether education provided in community pharmacies and monthly reminder calls can improve compliance with asthma medications. We hypothesize that those pediatric patients with asthma 12 months to 12 years of age who receive comprehensive asthma care as part of a validated intervention (1) who are randomized to receive enhanced community pharmacy care will have significantly greater compliance with inhaled corticosteroids (ICS) six months after enrollment when compared with patients receiving usual pharmacy care. As secondary outcomes, we further hypothesize that they will have less unscheduled healthcare utilization and improved functional outcomes and QOL. (1) Teach SJ, Crain EF, Quint DM, Hylan ML, Joseph JG. Improved Asthma Outcomes in a High Morbidity Pediatric Population: Results of an Emergency Department-based Randomized Clinical Trial. Archives of Pediatric and Adolescent Medicine. 2006;160:535-541.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
125

participants targeted

Target at P50-P75 for not_applicable asthma

Timeline
Completed

Started Jul 2006

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2006

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

January 17, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 18, 2007

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2009

Completed
Last Updated

August 25, 2015

Status Verified

August 1, 2015

Enrollment Period

2.8 years

First QC Date

January 17, 2007

Last Update Submit

August 21, 2015

Conditions

Asthma

Keywords

AsthmaComplianceRandomized clinical trial

Outcome Measures

Primary Outcomes (1)

  • Compliance with inhaled corticosteroids

    6 months following enrollment

Secondary Outcomes (2)

  • Unscheduled healthcare utilization for asthma

    6 months following enrollment

  • Quality of Life

    6 months following enrollment

Study Arms (1)

Enhanced Pharmacy Care

EXPERIMENTAL

Received enhanced community pharmacy based services.

Behavioral: Enhanced Pharmacy CareBehavioral: Control

Interventions

Enhanced Pharmacy CareBEHAVIORAL

Participants randomized to "Enhanced Pharmacy Care" will have their prescriptions electronically transmitted or faxed to one of the five participating pharmacies. Pharmacists will then provide real-time, targeted education around the purpose and use of the new and refilled ICS medications to study participants and their families at each point of contact, including rationale for their use, device teaching, dosage review, and importance of compliance. Families randomized to "enhanced care" will also be contacted monthly by phone and mail with reminders to fill their controller medications prescriptions and to seek ongoing longitudinal asthma care with their primary care providers.

Enhanced Pharmacy Care
ControlBEHAVIORAL

Usual care.

Enhanced Pharmacy Care

Eligibility Criteria

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

You may qualify if:

  • age between 12 months and 12 years, inclusive;
  • prior physician-diagnosed asthma;
  • prescription of an inhaled corticosteroid during the IMPACT DC Asthma Clinic visit,
  • a parent/guardian available for interview;
  • residence in one of the 5 zip codes in Washington, DC with the highest absolute numbers for asthma visits to the Emergency Department at Childrens National Medical Center (20019, 20020, 20032, 20002, 20011), and
  • insurance that covers at least part of the cost of medications.

You may not qualify if:

  • significant medical co-morbidities affecting the cardiorespiratory system;
  • enrollment in another asthma research study;
  • unavailability for telephone follow-up; or
  • primary language other than English.

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

Related Publications (1)

  • Teach SJ, Crain EF, Quint DM, Hylan ML, Joseph JG. Improved asthma outcomes in a high-morbidity pediatric population: results of an emergency department-based randomized clinical trial. Arch Pediatr Adolesc Med. 2006 May;160(5):535-41. doi: 10.1001/archpedi.160.5.535.

    PMID: 16651498BACKGROUND

MeSH Terms

Conditions

AsthmaPatient Compliance

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System DiseasesPatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Stephen J Teach, MD, MPH

    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
Chief, Division of Allergy and Immunology

Study Record Dates

First Submitted

January 17, 2007

First Posted

January 18, 2007

Study Start

July 1, 2006

Primary Completion

May 1, 2009

Study Completion

May 1, 2009

Last Updated

August 25, 2015

Record last verified: 2015-08

Locations

US(1)