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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00687310
Recruitment Status : Completed
First Posted : May 30, 2008
Last Update Posted : January 24, 2011
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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.

Condition or disease Intervention/treatment Phase
Asthma Behavioral: Educational intervention Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Does Tailored Education in Asthma Care Help Improve Patient Satisfaction, Adherence, and Quality of Life (TEACH) Trial
Study Start Date : December 2005
Actual Study Completion Date : January 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
U.S. FDA Resources

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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. ]

Secondary Outcome Measures :
  1. Mini-asthma Quality of Life questionnaire [ Time Frame: Visit 1 and during calls 1 and 2 ]
  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. ]
  3. 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. ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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].

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00687310

Sponsors and Collaborators
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

Responsible Party: Gloria Jordana - Scientific Director-GI/RITA, AstraZeneca Canada Inc. Identifier: NCT00687310     History of Changes
Other Study ID Numbers: D5890L00018
First Posted: May 30, 2008    Key Record Dates
Last Update Posted: January 24, 2011
Last Verified: January 2011

Keywords provided by AstraZeneca:
Asthma education
satisfaction adherence
Quality of Life
PIKO meter cluster
Symbicort® Turbuhaler®

Additional relevant MeSH terms:
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases