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

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00687310
First received: May 28, 2008
Last updated: January 21, 2011
Last verified: January 2011
  Purpose

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 Intervention Phase
Asthma
Behavioral: Educational intervention
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mini-asthma Quality of Life questionnaire [ Time Frame: Visit 1 and during calls 1 and 2 ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]

Enrollment: 160
Study Start Date: December 2005
Study Completion Date: January 2007
Arms Assigned Interventions
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.
Behavioral: Educational intervention
Tailored asthma education based on needs assessment

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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].
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00687310

Sponsors and Collaborators
AstraZeneca
Investigators
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
  More Information

No publications provided

Responsible Party: Gloria Jordana - Scientific Director-GI/RITA, AstraZeneca Canada Inc.
ClinicalTrials.gov Identifier: NCT00687310     History of Changes
Other Study ID Numbers: D5890L00018
Study First Received: May 28, 2008
Last Updated: January 21, 2011
Health Authority: Canada: Health Canada

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

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

ClinicalTrials.gov processed this record on October 21, 2014