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

Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00687310
• Other study ID #: D5890L00018
• Status: Completed
• Phase: Phase 4
• First received: May 28, 2008
• Last updated: January 21, 2011
• Start date: December 2005
• Est. completion date: January 2007

Study information

• Verified date: January 2011
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: January 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Asthma

Intervention

Behavioral:
• Educational intervention
Tailored asthma education based on needs assessment

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Secondary	Mini-asthma Quality of Life questionnaire		Visit 1 and during calls 1 and 2	No
Secondary	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.	No
Secondary	PIKO meter usage assessment		During the Call 2 to the educational intervention group subjects who received the PIKO meter during their educational session.	No