Clinical trial NCT05278000: Improving Adherence to Controller Medication in Children With Asthma
Official title: Improving Adherence to Controller Medication in Children With Asthma - the Unexplored Contribution of Behavioural Sciences
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Asthma in Children
Adherence, Medication
Keywords: Asthma, Adherence, social needs, scarcity, future discounting
Lead sponsor: St. Justine's Hospital
Sponsor class: OTHER
First posted: 2022-03-14
Enrollment: 201
Sex: ALL
Minimum age (years): 2
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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)

Brief 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.

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:

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.

Eligibility criteria: Inclusion Criteria:

* (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)

Exclusion Criteria:

* (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.

Primary outcomes:
measure: Rate of adherence to controller medication
timeFrame: 12 months of follow up
Secondary outcomes:
measure: Number of emergency room visits and/or hospitalizations related to asthma
timeFrame: 12 months of follow up
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: Asthma Clinic of the CHU Sainte-Justine
state: Quebec
Study officials:
affiliation: CHU Sainte-Justine Research Centre, Université de Montréal
name: Olivier Drouin, MD, MSc MPH
role: PRINCIPAL_INVESTIGATOR
References: