Does Tailored Education in Asthma Care Help Improve Patient Satisfaction, Adherence, and Quality of Life (TEACH) Trial

January 21, 2011 updated by: AstraZeneca
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

160

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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].

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 1
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
Tailored asthma education based on needs assessment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Patient's satisfaction with asthma education
Time Frame: At the initial visit (Visit 1) and during the final call (Call 2) or at the time of premature discontinuation from the trial.
At the initial visit (Visit 1) and during the final call (Call 2) or at the time of premature discontinuation from the trial.

Secondary Outcome Measures

Outcome Measure
Time Frame
Mini-asthma Quality of Life questionnaire
Time Frame: Visit 1 and during calls 1 and 2
Visit 1 and during calls 1 and 2
Asthma control parameters
Time Frame: At baseline, as well as during Call 1 and Call 2 for both the usual care group and the enducational intervention group.
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
Time Frame: During the Call 2 to the educational intervention group subjects who received the PIKO meter during their educational session.
During the Call 2 to the educational intervention group subjects who received the PIKO meter during their educational session.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

  • Principal Investigator: 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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2005

Study Completion (Actual)

January 1, 2007

Study Registration Dates

First Submitted

May 28, 2008

First Submitted That Met QC Criteria

May 29, 2008

First Posted (Estimate)

May 30, 2008

Study Record Updates

Last Update Posted (Estimate)

January 24, 2011

Last Update Submitted That Met QC Criteria

January 21, 2011

Last Verified

January 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D5890L00018

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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