- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01521247
Implementation of a Pediatric-to-adult Asthma Transition Program
Despite the clear and often stated need, a formal transition program does not exist for asthma patients as they move from pediatric to adult care in Western Canada. This population is not having their health care needs met. The investigators proposed study would evaluate a well structured transition program designed to facilitate continuity of care for this at risk patient population.
Primary hypothesis: A pediatric-to-adult asthma transition program will improve the asthma-specific quality of life of young asthma patients in the Calgary area over a 1 year period.
Secondary hypothesis: A pediatric-to-adult asthma transition program will improve asthma control, decrease asthma exacerbations, and reduce health care utilization in young asthma patients in the Calgary area over a 1 year period.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Alberta
-
Calgary, Alberta, Canada, T3B 6A8
- Calgary Regional Pediatric Asthma Clinic
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- clinical diagnosis of asthma (as confirmed by a pediatric respirologist or pediatrician with asthma expertise, and including evidence of variable airflow obstruction, bronchial hyperresponsiveness, airway inflammation, and/or response to therapy)
Exclusion Criteria:
- patients who are known to be non-adherent within the Calgary Regional Pediatric Asthma Clinic (defined as >50% missed appointments over a 2 year period)
- patients unable to complete pulmonary function testing
- patients with a history of significant respiratory comorbid conditions (including history of cystic fibrosis, alpha-1 antitrypsin deficiency, and lung transplant - rhinosinusitis patients will not be excluded)
- patients unable to provide consent.
Study Plan
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Control group
Usual care.
|
|
Other: Asthma Transition Program
|
Asthma Education.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Asthma Quality of Life Questionnaire with Standardized Activities [AQLQ(S)]
Time Frame: 12 months
|
AQLQ(S) will be recorded at baseline, 6 months, and 12 months.
The primary outcome will be the change in AQLQ(S) from baseline to 12 months.
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Asthma Control Questionnaire (ACQ)
Time Frame: 12 months
|
The ACQ will be administered at baseline, 6 months, and 12 months.
The secondary outcome will assess change in ACQ from baseline to 12 months.
|
12 months
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Mary Noseworthy, MD, Alberta Children's Hospital
- Study Director: Rodel Padua, RRT
- Study Director: Sheldon Spier, MD, Alberta Children's Hospital
- Study Director: Ward Flemons, MD, University of Calgary
- Principal Investigator: Warren Davidson, MD, University of Calgary
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AJMG-2010
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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