Back to resultsDoes Tailored Education in Asthma Care Help Improve Patient Satisfaction, Adherence, and Quality of Life (TEACH) Trial
Primary Purpose
Asthma
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Educational intervention
Sponsored by
About this trial
This is an interventional supportive care trial for Asthma focused on measuring Asthma education, satisfaction adherence, Quality of Life, PIKO meter cluster, Symbicort® Turbuhaler®
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].
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
1
Arm Description
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.
Outcomes
Primary Outcome Measures
Patient's satisfaction with asthma education
Secondary Outcome Measures
Mini-asthma Quality of Life questionnaire
Asthma control parameters
PIKO meter usage assessment
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00687310
Brief Title
Does Tailored Education in Asthma Care Help Improve Patient Satisfaction, Adherence, and Quality of Life (TEACH) Trial
Official Title
Does Tailored Education in Asthma Care Help Improve Patient Satisfaction, Adherence, and Quality of Life (TEACH) Trial
Study Type
Interventional
2. Study Status
Record Verification Date
January 2011
Overall Recruitment Status
Completed
Study Start Date
December 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
January 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
AstraZeneca
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
Asthma education, satisfaction adherence, Quality of Life, PIKO meter cluster, Symbicort® Turbuhaler®
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
160 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Other
Arm Description
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 Type
Behavioral
Intervention Name(s)
Educational intervention
Intervention Description
Tailored asthma education based on needs assessment
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
Mini-asthma Quality of Life questionnaire
Time Frame
Visit 1 and during calls 1 and 2
Title
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.
Title
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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].
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew McIvor, M.D., M.Sc., FRCP(E), FRCP(C)
Organizational Affiliation
McMaster University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Christopher Licskai, M.D., FRCPC
Organizational Affiliation
University of Ontario London Ontario Canada
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Alan Kaplan, M.D., CCFP, CCFP(E.M.)
Organizational Affiliation
York Central Hospital, Richmond Hill, Ontario Canada
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Does Tailored Education in Asthma Care Help Improve Patient Satisfaction, Adherence, and Quality of Life (TEACH) Trial
We'll reach out to this number within 24 hrs