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Completed

NCT Number: NCT05278000

Improving Adherence to Controller Medication in Children With Asthma

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Presence of scarcity mindset

Other

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

Other names: Presence of unmet social needs,, Rate of future discounting

Primary outcomes

  1. 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.

Secondary outcomes

  1. Number of emergency room visits and/or hospitalizations related to asthma

    Time frame: 12 months of follow up

    Number of emergency room visits and/or hospitalizations related to asthma per participant.

Sponsors and collaborators

Lead sponsor

St. Justine's Hospital

Other

Registry information

Official study title

Improving Adherence to Controller Medication in Children With Asthma - the Unexplored Contribution of Behavioural Sciences

Acronym: PACIFI

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Mar 14, 2022
Registry last updated
Jul 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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