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

NCT ID: NCT00687310

Last Updated: 2011-01-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 160 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-12-31
• Study Completion Date: 2007-01-31

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.

Conditions

Asthma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: OTHER

Educational intervention

Intervention Type: BEHAVIORAL

Tailored asthma education based on needs assessment

Interventions

Educational intervention

Tailored asthma education based on needs assessment

Intervention Type: BEHAVIORAL

Eligibility Criteria

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].

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AstraZeneca

INDUSTRY

Sponsor Role: lead

Responsible Party

AstraZeneca Canada Inc.

Principal Investigators

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

Role: PRINCIPAL_INVESTIGATOR

McMaster University

Christopher Licskai, M.D., FRCPC

Role: PRINCIPAL_INVESTIGATOR

University of Ontario London Ontario Canada

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

Role: PRINCIPAL_INVESTIGATOR

York Central Hospital, Richmond Hill, Ontario Canada

Other Identifiers

D5890L00018

Identifier Type: -

Identifier Source: org_study_id