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Clinical Trials/NCT00687310
NCT00687310CompletedPhase 4

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

AstraZeneca0 sites160 target enrollmentStarted: December 1, 2005Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Phase 4
Status
Completed
Enrollment
160
Primary Endpoint
Patient's satisfaction with asthma education

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
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].

Arms & Interventions

1

Other

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.

Intervention: Educational intervention (Behavioral)

Outcomes

Primary Outcomes

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 Outcomes

  • 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.)

Investigators

Sponsor Class
Industry

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