AsthmaNCT01521247
Implementation of a Pediatric-to-adult Asthma Transition Program
A study testing Asthma Transition Program in people with Asthma and Education, run by University of Calgary at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 17 to 19 years
- What is being tested?
- Asthma Transition Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2010to Jul 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 17 to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Calgary Regional Pediatric Asthma Clinic
Calgary, Alberta, T3B 6A8
About this study
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.
- Being tested
- Asthma Transition Program
- Keywords
- Asthma, Transition program, Pediatric, Adult
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Asthma Transition ProgramOther
Also called Asthma Education and Referral.
Asthma Education.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | Usual care. |
| Asthma Transition Program | Other | Asthma Transition Program Receives: Other: Asthma Transition Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (1)
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2012 (estimated)
- Study startApr 2010
- Primary completionJul 2014
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by University of CalgaryThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Warren Davidson, University of Calgary
- Investigators
- Mary Noseworthy, MD, Study director, Alberta Children's HospitalRodel Padua, RRT, Study directorSheldon Spier, MD, Study director, Alberta Children's HospitalWard Flemons, MD, Study director, University of CalgaryWarren Davidson, MD, Principal investigator, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01521247
- Sponsor's protocol ID
- AJMG-2010
- Status last verified
- Sep 2016
- First submitted
- 23 Jan 2012
- Last updated
- 9 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of a Pediatric-to-adult Asthma Transition Program
- ClinicalTrials.gov ID
- NCT01521247
- Acronym / sponsor ID
- AJMG-2010
- Keywords
- Asthma, Transition program, Pediatric, Adult
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Study start
- Apr 2010
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 30 Jan 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –Usual care. |
| Asthma Transition Program | Other | Other: Asthma Transition ProgramAsthma Transition Program |
Who may qualify
- Ages
- 17 to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- 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)
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Asthma Transition ProgramAlso: Asthma Education and Referral.Asthma Education. | Other | Asthma Transition Program |
Primary outcome
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.
1 secondary outcome
Asthma Control Questionnaire (ACQ)
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mary Noseworthy, MD study director
Alberta Children's Hospital
Rodel Padua, RRT study director
Sheldon Spier, MD study director
Alberta Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Asthma Transition Program in people with Asthma and Education, run by University of Calgary at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Asthma Quality of Life Questionnaire with Standardized Activities [AQLQ(S)] (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2016.