Asthma in ChildrenPACIFINCT05278000
Improving Adherence to Controller Medication in Children With Asthma
An observational study of Asthma in Children and Adherence, Medication, run by St. Justine's Hospital at 1 site in Canada.
Trial summary
Asthma is a common pediatric condition that can be well controlled with regular use of controller medications, however adherence to these is low, resulting in preventable exacerbations and important short- and long-term morbidity. Read more about this study
- Who is it for?
- Ages 2 to 17 years
- Conditions the study is for
- Asthma in Children, Adherence, Medication
- What is being tested?
- Presence of scarcity mindset
- How many people
- 201 participants
- Where
- 1 siteCanada
- Study dates
- 25 Aug 2022to 18 Jul 2025
- Phase
- Observational
- 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 2 to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: 300 families of children aged 2-17 who are followed at the CHU Sainte-Justine asthma or pulmonology clinic with a diagnosis of asthma (made according to national guidelines) and have a documented prescription for a controller medication at recruitment visit: inhaled corticosteroids ± Long-acting beta agonists (LABA) and/or Leukotriene receptor antagonists (LTRA)
Who may be able to join
- (1) child with documented prescription for a controller medication at recruitment visit: inhaled corticosteroids ± Long-acting beta agonists (LABA) and/or Leukotriene receptor antagonists (LTRA)
- (2) consent to reMED database (medication data registry)
Who cannot join
- (1) Child with other chronic pulmonary disease (e.g., cystic fibrosis) that could influence asthma control,
- (2) parents' insufficient knowledge of French or English to complete questionnaires either alone or with support from a research assistant.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Improving Adherence to Controller Medication in Children With Asthma - the Unexplored Contribution of Behavioural Sciences
Asthma is a common pediatric condition that can be well controlled with regular use of controller medications, however adherence to these is low, resulting in preventable exacerbations and important short- and long-term morbidity. This project's aim is to understand cognitive factors influencing adherence to medication among children with asthma, examining specifically the influence of scarcity (a mindset experienced by those with less than they need, which is cognitively taxing) and future discounting (the focus on present concerns at the expense of distant ones).
Using a single-centre, 12-month, prospective observation cohort study of 300 families of children with asthma, the objectives of this study are to:
Read more
- Identify the relationship between scarcity, future discounting, and adherence to asthma medication.
- Evaluate whether unmet social needs are associated with scarcity and future discounting.
- Determine whether scarcity and future discounting mediate the relationship between unmet social needs and adherence to medication.
Primary outcome will be adherence to controller medication, which will be measured for the 12 months of follow-up on a scale of 0 to 100%, by the 'proportion of prescribed days covered (PPDC)', a validated index calculated as the number of days for which the drug was dispensed by a pharmacy, divided by the number of days for which it was prescribed. Other measures include screening families for unmet social needs, psychometric testing to document scarcity and future discounting.
This study will increase our understanding of how cognitive factors influence adherence to asthma controller medication, which will be instrumental in developing targeted interventions to improve adherence, especially for families experiencing with unmet social needs.
Read the detailed description
Background: Asthma affects one in ten children and is among the most common causes of emergency department (ED) visits and hospitalization in paediatrics. Regular use of asthma controller medications is effective at controlling the condition, yet adherence to medication is low, resulting in preventable exacerbations and important short- and long-term morbidity. Higher adherence to asthma controller medications leads to more favourable health trajectories. Behavioural reasons for poor medication adherence may include cognitive mechanisms, such as scarcity (a mindset experienced by those with less than they need, which is cognitively taxing), and future discounting (the focus on present concerns at the expense of distant ones). Children living with socioeconomic disadvantage suffer a disproportionate burden of disease and are more likely to have unmet social needs such as food insecurity and unstable housing, leading to scarcity and future discounting.
Specific Objectives: This project's aim is to understand cognitive factors influencing adherence to medication among children with asthma, examining specifically the influence of scarcity and future discounting. Our objectives are to:
- Identify the relationship between scarcity, future discounting, and adherence to asthma medication.
- Evaluate whether unmet social needs are associated with scarcity and future discounting.
- Determine whether scarcity and future discounting mediate the relationship between unmet social needs and adherence to medication.
Design: A single-centre, 24-month, prospective observational cohort study of 300 families of children with asthma. Follow-up includes two data collection time points at 6- and 12-months after recruitment.
Primary outcome will be adherence to controller medication, which will be measured for the 12 months of follow-up on a scale of 0 to 100%, by the 'proportion of prescribed days covered (PPDC)', a validated index calculated as the number of days for which the drug was dispensed by a pharmacy, divided by the number of days for which it was prescribed.
Other measures include: screening families for unmet social needs, psychometric testing to document scarcity and future discounting.
Relevance: This study will increase our knowledge of cognitive factors influencing adherence to asthma controller medication and will be instrumental in developing targeted interventions to improve adherence, especially for families experiencing with unmet social needs.
- Conditions
- Asthma in Children, Adherence, Medication
- Being tested
- Presence of scarcity mindset
- Keywords
- Asthma, Adherence, social needs, scarcity, future discounting
- Medical subject headings
- Medication Adherence, Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Presence of scarcity mindsetOther
Also called Presence of unmet social needs,, Rate of future discounting
This observational study will examine whether
- Individuals exhibiting a scarcity mindset have lower adherence to asthma controller medication
- Individuals with higher rates of future discounting have lower adherence to controller medication
- Individuals with unmet social needs are more likely to experience scarcity and have higher rates of future discounting, and whether these relationships mediate adherence to asthma controller medication
| Study group | Role | What they receive |
|---|---|---|
| Children aged 2-17 years with asthma | Parents of children aged 2-17 years seen at CHU Sainte-Justine asthma clinic with a diagnosis of asthma will be eligible for the study Receives: Other: Presence of scarcity mindset |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of adherence to controller medication
Measured on a scale of 0 to 100% by the proportion of prescribed days covered (PPDC), a well-validated index calculated as the number of days for which the drug was dispensed by a pharmacy, divided by the number of days for which it was prescribed. The PPDC will be calculated using data from the medical records and a medication database, reMED.
Measured: 12 months of follow up
Secondary outcomes (1)
Number of emergency room visits and/or hospitalizations related to asthma
Number of emergency room visits and/or hospitalizations related to asthma per participant.
Measured: 12 months of follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2022
- Study start25 Aug 2022
- Primary completion12 Jul 2025
- Study completion18 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Asthma in ChildrenStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 201 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Justine's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Olivier Drouin, M.D., M.Sc M.P.H., St. Justine's Hospital
- Investigators
- Olivier Drouin, MD, MSc MPH, Principal investigator, CHU Sainte-Justine Research Centre, Université de Montréal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05278000
- Sponsor's protocol ID
- 461392
- Acronym
- PACIFI
- Status last verified
- Jul 2025
- First submitted
- 3 Mar 2022
- Last updated
- 23 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Drouin O, Perez T, Barnett TA, Ducharme FM, Fleegler E, Garg A, Lavoie K, Li P, Metras ME, Sultan S, Tse SM, Zhao J. Impact of Unmet Social Needs, Scarcity, and Future Discounting on Adherence to Treatment in Children With Asthma: Protocol for a Prospective Cohort Study. JMIR Res Protoc. 2023 Mar 7;12:e37318. doi: 10.2196/37318.
PubMed 36881458
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Adherence to Controller Medication in Children With Asthma - the Unexplored Contribution of Behavioural Sciences
- ClinicalTrials.gov ID
- NCT05278000
- Acronym / sponsor ID
- PACIFI / 461392
- Conditions
- Asthma in Children, Adherence, Medication
- Keywords
- Asthma, Adherence, social needs, scarcity, future discounting
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 201 participants (actual)
- Lead sponsor
- St. Justine's HospitalUniversity, hospital or other
- Study start
- 25 Aug 2022 (actual)
- Primary completion
- 12 Jul 2025 (actual)
- Study completion
- 18 Jul 2025 (actual)
- First posted
- 14 Mar 2022 (actual)
- 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.
Asthma is a common pediatric condition that can be well controlled with regular use of controller medications, however adherence to these is low, resulting in preventable exacerbations and important short- and long-term morbidity. This project's aim is to understand cognitive factors influencing adherence to medication among children with asthma, examining specifically the influence of scarcity (a mindset experienced by those with less than they need, which is cognitively taxing) and future discounting (the focus on present concerns at the expense of distant ones).
Using a single-centre, 12-month, prospective observation cohort study of 300 families of children with asthma, the objectives of this study are to:
- Identify the relationship between scarcity, future discounting, and adherence to asthma medication.
- Evaluate whether unmet social needs are associated with scarcity and future discounting.
- Determine whether scarcity and future discounting mediate the relationship between unmet social needs and adherence to medication.
Primary outcome will be adherence to controller medication, which will be measured for the 12 months of follow-up on a scale of 0 to 100%, by the 'proportion of prescribed days covered (PPDC)', a validated index calculated as the number of days for which the drug was dispensed by a pharmacy, divided by the number of days for which it was prescribed. Other measures include screening families for unmet social needs, psychometric testing to document scarcity and future discounting.
This study will increase our understanding of how cognitive factors influence adherence to asthma controller medication, which will be instrumental in developing targeted interventions to improve adherence, especially for families experiencing with unmet social needs.
Detailed description
Background: Asthma affects one in ten children and is among the most common causes of emergency department (ED) visits and hospitalization in paediatrics. Regular use of asthma controller medications is effective at controlling the condition, yet adherence to medication is low, resulting in preventable exacerbations and important short- and long-term morbidity. Higher adherence to asthma controller medications leads to more favourable health trajectories. Behavioural reasons for poor medication adherence may include cognitive mechanisms, such as scarcity (a mindset experienced by those with less than they need, which is cognitively taxing), and future discounting (the focus on present concerns at the expense of distant ones). Children living with socioeconomic disadvantage suffer a disproportionate burden of disease and are more likely to have unmet social needs such as food insecurity and unstable housing, leading to scarcity and future discounting.
Specific Objectives: This project's aim is to understand cognitive factors influencing adherence to medication among children with asthma, examining specifically the influence of scarcity and future discounting. Our objectives are to:
- Identify the relationship between scarcity, future discounting, and adherence to asthma medication.
- Evaluate whether unmet social needs are associated with scarcity and future discounting.
- Determine whether scarcity and future discounting mediate the relationship between unmet social needs and adherence to medication.
Design: A single-centre, 24-month, prospective observational cohort study of 300 families of children with asthma. Follow-up includes two data collection time points at 6- and 12-months after recruitment.
Primary outcome will be adherence to controller medication, which will be measured for the 12 months of follow-up on a scale of 0 to 100%, by the 'proportion of prescribed days covered (PPDC)', a validated index calculated as the number of days for which the drug was dispensed by a pharmacy, divided by the number of days for which it was prescribed.
Other measures include: screening families for unmet social needs, psychometric testing to document scarcity and future discounting.
Relevance: This study will increase our knowledge of cognitive factors influencing adherence to asthma controller medication and will be instrumental in developing targeted interventions to improve adherence, especially for families experiencing with unmet social needs.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children aged 2-17 years with asthma | – | Other: Presence of scarcity mindsetParents of children aged 2-17 years seen at CHU Sainte-Justine asthma clinic with a diagnosis of asthma will be eligible for the study |
Who may qualify
- Ages
- 2 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- 300 families of children aged 2-17 who are followed at the CHU Sainte-Justine asthma or pulmonology clinic with a diagnosis of asthma (made according to national guidelines) and have a documented prescription for a controller medication at recruitment visit: inhaled corticosteroids ± Long-acting beta agonists (LABA) and/or Leukotriene receptor antagonists (LTRA)
Key inclusion criteria (2 listed)
- (1) child with documented prescription for a controller medication at recruitment visit: inhaled corticosteroids ± Long-acting beta agonists (LABA) and/or Leukotriene receptor antagonists (LTRA)
- (2) consent to reMED database (medication data registry)
Key exclusion criteria (2 listed)
- (1) Child with other chronic pulmonary disease (e.g., cystic fibrosis) that could influence asthma control,
- (2) parents' insufficient knowledge of French or English to complete questionnaires either alone or with support from a research assistant.
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 |
|---|---|---|
| Presence of scarcity mindsetAlso: Presence of unmet social needs,, Rate of future discountingThis observational study will examine whether 1. Individuals exhibiting a scarcity mindset have lower adherence to asthma controller medication 2. Individuals with higher rates of future discounting have lower adherence to controller medication 3. Individuals with unmet social needs are more likely to experience scarcity and have higher rates of future discounting, and whether these relationships mediate adherence to asthma controller medication | Other | Children aged 2-17 years with asthma |
Primary outcome
Rate of adherence to controller medication
Time frame: 12 months of follow up
Measured on a scale of 0 to 100% by the proportion of prescribed days covered (PPDC), a well-validated index calculated as the number of days for which the drug was dispensed by a pharmacy, divided by the number of days for which it was prescribed. The PPDC will be calculated using data from the medical records and a medication database, reMED.
1 secondary outcome
Number of emergency room visits and/or hospitalizations related to asthma
Time frame: 12 months of follow up
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 23 Jul 2025.
- Background: PubMed 36881458Drouin O, Perez T, Barnett TA, Ducharme FM, Fleegler E, Garg A, Lavoie K, Li P, Metras ME, Sultan S, Tse SM, Zhao J. Impact of Unmet Social Needs, Scarcity, and Future Discounting on Adherence to Treatment in Children With Asthma: Protocol for a Prospective Cohort Study. JMIR Res Protoc. 2023 Mar 7;12:e37318. doi: 10.2196/37318.
- Individual participant dataSharing planned: No
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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.
Olivier Drouin, MD, MSc MPH principal investigator
CHU Sainte-Justine Research Centre, Université de Montréal
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma in Children and Adherence, Medication, run by St. Justine's Hospital 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 2 inclusion and 2 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 23 Jul 2025. 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?
Rate of adherence to controller medication (time frame: 12 months of follow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05278000, which also lists 1 linked publication.
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 23 Jul 2025.