NCT00687310

Brief Summary

The primary purpose of this study is to assess whether tailored patient education for patients on Symbicort® Turbuhaler® therapy improves patient satisfaction, adherence and Quality of Life.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
160

participants targeted

Target at P50-P75 for phase_4 asthma

Timeline
Completed

Started Dec 2005

Shorter than P25 for phase_4 asthma

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

December 1, 2005

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2007

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

May 28, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 30, 2008

Completed
Last Updated

January 24, 2011

Status Verified

January 1, 2011

First QC Date

May 28, 2008

Last Update Submit

January 21, 2011

Conditions

Asthma

Keywords

Asthma educationsatisfaction adherenceQuality of LifePIKO meter clusterSymbicort® Turbuhaler®

Outcome Measures

Primary Outcomes (1)

  • Patient's satisfaction with asthma education

    At the initial visit (Visit 1) and during the final call (Call 2) or at the time of premature discontinuation from the trial.

Secondary Outcomes (3)

  • Mini-asthma Quality of Life questionnaire

    Visit 1 and during calls 1 and 2

  • Asthma control parameters

    At baseline, as well as during Call 1 and Call 2 for both the usual care group and the enducational intervention group.

  • PIKO meter usage assessment

    During the Call 2 to the educational intervention group subjects who received the PIKO meter during their educational session.

Study Arms (1)

1

OTHER

Educational Intervention At the initial visit (Visit 1), patients in the educational intervention group will complete a short Needs Assessment Questionnaire to help the investigator/nurse determine which section(s) of the tailored patient education booklet to give to, educate, and provide instruction on to the patient. This may, at the discretion of the investigator, include providing their patient with a peak flow meter and instructions on its use.Visit 2 will be scheduled for 1-month after the Visit 1 for the education intervention group. All educational materials provided at Visit 1 will be reviewed with the patient at Visit 2. The investigator/nurse will reassess the patient's use of the Turbuhaler® and asthma treatment plan. Patients will also be asked about any adverse events that may have occurred since Visit 1 and/or are observed at Visit 2. Once Visit 2 is completed with the patient, the investigator/nurse will complete the Educator Satisfaction Questionnaire.

Behavioral: Educational intervention

Interventions

Educational interventionBEHAVIORAL

Tailored asthma education based on needs assessment

1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with the diagnosis of asthma.
  • Patients with asthma, where the use of Symbicort® Turbuhaler® is indicated and would have been prescribed by the investigator as part of usual care.
  • Patient who have public or private insurance coverage for Symbicort® Turbuhaler® or are willing to pay for this medication for the duration of the trial.

You may not qualify if:

  • Patients who have been treated wth Symbicort® Turbuhaler® in the preceding 3 months.
  • A history of smoking \[i.e., 10 pack-years where one pack-year equals one pack (20 cigarettes) per day for one year, or equivalent\].

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Asthma

Interventions

Early Intervention, Educational

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Child Health ServicesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesPreventive Health Services

Study Officials

  • Andrew McIvor, M.D., M.Sc., FRCP(E), FRCP(C)

    McMaster University

    PRINCIPAL INVESTIGATOR

  • Christopher Licskai, M.D., FRCPC

    University of Ontario London Ontario Canada

    PRINCIPAL INVESTIGATOR

  • Alan Kaplan, M.D., CCFP, CCFP(E.M.)

    York Central Hospital, Richmond Hill, Ontario Canada

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 28, 2008

First Posted

May 30, 2008

Study Start

December 1, 2005

Study Completion

January 1, 2007

Last Updated

January 24, 2011

Record last verified: 2011-01