Improving Adherence to Controller Medication in Children With Asthma (PACIFI)

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:

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.

Study Overview

• Status: Recruiting
• Conditions: Asthma in Children; Adherence, Medication
• Intervention / Treatment: Other: Presence of scarcity mindset

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.

• Study Type: Observational
• Enrollment (Estimated): 300

Contacts and Locations

• Study Contact: Name: Tamara Perez, MSc; Phone Number: 5143454931; Email: tamara.perez.hsj@ssss.gouv.qc.ca
• Study Contact Backup: Name: Olivier Drouin, MD, MSc MPH; Phone Number: 5143454931; Email: o.drouin@umontreal.ca

Study Locations

• Canada
  • Quebec
    • Montréal, Quebec, Canada, H3T 1C5
      • Recruiting
      • Asthma Clinic of the CHU Sainte-Justine
      • Contact: Olivier Drouin, MD, MPH, MSc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 17 years (Child)
• Accepts Healthy Volunteers: No

• 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)

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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

Other: Presence of scarcity mindset; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	12 months of follow up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of emergency room visits and/or hospitalizations related to asthma	Number of emergency room visits and/or hospitalizations related to asthma per participant.	12 months of follow up

Collaborators and Investigators

• Sponsor: St. Justine's Hospital
• Investigators: Principal Investigator: Olivier Drouin, MD, MSc MPH, CHU Sainte-Justine Research Centre, Université de Montréal

Study record dates

Study Major Dates

• Study Start (Actual): August 25, 2022
• Primary Completion (Estimated): July 1, 2024
• Study Completion (Estimated): July 1, 2025

Study Registration Dates

• First Submitted: March 3, 2022
• First Submitted That Met QC Criteria: March 3, 2022
• First Posted (Actual): March 14, 2022

Study Record Updates

• Last Update Posted (Estimated): December 18, 2023
• Last Update Submitted That Met QC Criteria: December 12, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Asthma, Adherence, social needs, scarcity, future discounting
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma
• Other Study ID Numbers: 461392

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No