NCT01521247

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable asthma

Timeline
Completed

Started Apr 2010

Longer than P75 for not_applicable asthma

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2010

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

January 23, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 30, 2012

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
Last Updated

September 9, 2016

Status Verified

September 1, 2016

Enrollment Period

4.3 years

First QC Date

January 23, 2012

Last Update Submit

September 8, 2016

Conditions

Keywords

AsthmaTransition programPediatricAdult

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Asthma Control Questionnaire (ACQ)

    12 months

Study Arms (2)

Control group

NO INTERVENTION

Usual care.

Asthma Transition Program

OTHER

Asthma Transition Program

Other: Asthma Transition Program

Interventions

Asthma Education.

Also known as: Asthma Education and Referral.
Asthma Transition Program

Eligibility Criteria

Age17 Years - 19 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Calgary Regional Pediatric Asthma Clinic

Calgary, Alberta, T3B 6A8, Canada

Location

MeSH Terms

Conditions

Asthma

Interventions

Referral and Consultation

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

Professional PracticeOrganization and AdministrationHealth Services Administration

Study Officials

  • 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

    STUDY DIRECTOR
  • Warren Davidson, MD

    University of Calgary

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 23, 2012

First Posted

January 30, 2012

Study Start

April 1, 2010

Primary Completion

July 1, 2014

Study Completion

July 1, 2015

Last Updated

September 9, 2016

Record last verified: 2016-09

Locations