Implementation of a Pediatric-to-adult Asthma Transition Program

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2012 by University of Calgary.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Warren Davidson, University of Calgary
ClinicalTrials.gov Identifier:
NCT01521247
First received: January 23, 2012
Last updated: January 25, 2012
Last verified: January 2012
  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

Resource links provided by NLM:


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.


Estimated Enrollment: 34
Study Start Date: April 2010
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Control group
Usual care.
Other: Asthma Transition Program
Asthma Education.
Other Name: Asthma Education and Referral.
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
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

Contacts
Contact: Warren Davidson, MD, FRCPC, MHSc, FCCP 403-943-8864 wdavidso@ucalgary.ca

Locations
Canada, Alberta
Calgary Regional Pediatric Asthma Clinic Recruiting
Calgary, Alberta, Canada, T3B 6A8
Sub-Investigator: Mary Noseworthy, MD         
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

No publications provided

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: January 25, 2012
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 July 23, 2014