Implementation of a Pediatric-to-adult Asthma Transition Program

Asthma Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01521247
• Other study ID #: AJMG-2010
• Status: Completed
• Phase: N/A
• First received: January 23, 2012
• Last updated: September 8, 2016
• Start date: April 2010
• Est. completion date: July 2015

Study information

• Verified date: September 2016
• Source: University of Calgary
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: July 2015
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 17 Years to 19 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Asthma
• Education

Intervention

Other:
• Asthma Transition Program
Asthma Education.

Locations

Country	Name	City	State
Canada	Calgary Regional Pediatric Asthma Clinic	Calgary	Alberta

Sponsors (1)

Lead Sponsor	Collaborator
University of Calgary

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Asthma Quality of Life Questionnaire with Standardized Activities [AQLQ(S)]	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	No
Secondary	Asthma Control Questionnaire (ACQ)	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	No