Implementation of a Pediatric-to-adult Asthma Transition Program

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Asthma; Education	Other: Asthma Transition Program	Not Applicable

Study Design

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	30 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Study Start Date :	April 2010
Actual Primary Completion Date :	July 2014
Actual Study Completion Date :	July 2015

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
No Intervention: Control group; Usual care.
Asthma Transition Program; Asthma Transition Program	Other: Asthma Transition Program; Asthma Education.; Other Name: Asthma Education and Referral.

Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. 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.

Secondary Outcome Measures :

1. 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.

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	17 Years to 19 Years (Child, Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

Canada, Alberta
Calgary Regional Pediatric Asthma Clinic
Calgary, Alberta, Canada, T3B 6A8

Sponsors and Collaborators

University of Calgary

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

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Warren Davidson, Principal Investigator, University of Calgary
ClinicalTrials.gov Identifier:	NCT01521247 History of Changes
Other Study ID Numbers:	AJMG-2010
First Posted:	January 30, 2012
Last Update Posted:	September 9, 2016
Last Verified:	September 2016

Keywords provided by Warren Davidson, University of Calgary:

Asthma; Transition program; Pediatric; Adult

Additional relevant MeSH terms:

Asthma; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases	Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases