Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05278000 |
| Other study ID # |
461392 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
August 25, 2022 |
| Est. completion date |
July 2025 |
Study information
| Verified date |
December 2023 |
| Source |
St. Justine's Hospital |
| Contact |
Tamara Perez, MSc |
| Phone |
5143454931 |
| Email |
tamara.perez.hsj[@]ssss.gouv.qc.ca |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical 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. 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:
1. Identify the relationship between scarcity, future discounting, and adherence to asthma
medication.
2. Evaluate whether unmet social needs are associated with scarcity and future discounting.
3. 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.
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:
1. Identify the relationship between scarcity, future discounting, and adherence to asthma
medication.
2. Evaluate whether unmet social needs are associated with scarcity and future discounting.
3. 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.
