Implementation of a Pediatric-to-adult Asthma Transition Program

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Warren Davidson, University of Calgary

ClinicalTrials.gov Identifier:

NCT01521247

First received: January 23, 2012

Last updated: September 8, 2016

Last verified: September 2016

History of Changes

Purpose

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	Intervention
Asthma Education	Other: Asthma Transition Program


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

Further study details as provided by University of Calgary:

Primary Outcome Measures:

Asthma Quality of Life Questionnaire with Standardized Activities [AQLQ(S)] [ Time Frame: 12 months ] [ Designated as safety issue: No ]
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:

Asthma Control Questionnaire (ACQ) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
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.


Enrollment:	30
Study Start Date:	April 2010
Study Completion Date:	July 2015
Primary Completion Date:	July 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
No Intervention: Control group Usual care.
Asthma Transition Program Asthma Transition Program	Other: Asthma Transition Program Asthma Education. Other Name: Asthma Education and Referral.

Eligibility


Ages Eligible for Study:	17 Years to 19 Years (Child, Adult)
Genders Eligible for Study:	Both
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

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: NCT01521247

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


Responsible Party:	Warren Davidson, Principal Investigator, University of Calgary
ClinicalTrials.gov Identifier:	NCT01521247 History of Changes
Other Study ID Numbers:	AJMG-2010
Study First Received:	January 23, 2012
Last Updated:	September 8, 2016
Health Authority:	Canada: Ethics Review Committee

Keywords provided by 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

ClinicalTrials.gov processed this record on September 23, 2016

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