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

Phase 4

Completed

• Conditions: Asthma
• Interventions: Behavioral: Educational intervention

• Registration Number: NCT00687310
• Lead Sponsor: AstraZeneca

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-12
• Study Completion: 2007-01
• Study First Submitted: 2008-05-28
• Study First Submitted QC: 2008-05-29
• Study First Posted: 2008-05-30
• Status Verified: 2011-01
• Last Update Submitted: 2011-01-21
• Last Update Posted: 2011-01-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 160

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.

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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].

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Educational intervention	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.