Improving Adherence to Controller Medication in Children With Asthma

NCT ID: NCT05278000

Last Updated: 2025-07-23

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 201 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-08-25
• Study Completion Date: 2025-07-18

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.

Conditions

Asthma in Children; Adherence, Medication

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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

Presence of scarcity mindset

Intervention Type: OTHER

This 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

Interventions

Presence of scarcity mindset

This 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

Intervention Type: OTHER

Other Intervention Names

Presence of unmet social needs,; Rate of future discounting

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.

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

St. Justine's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Olivier Drouin, M.D., M.Sc M.P.H.

Pediatrician and Clinical Assistant Professor, Departments of Paediatrics and Department of Social and Preventive Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Olivier Drouin, MD, MSc MPH

Role: PRINCIPAL_INVESTIGATOR

CHU Sainte-Justine Research Centre, Université de Montréal

Locations

Asthma Clinic of the CHU Sainte-Justine

Montreal, Quebec, Canada

Countries

Canada

References

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.

Reference Type: BACKGROUND

PMID: 36881458 (View on PubMed)

Other Identifiers

461392

Identifier Type: -

Identifier Source: org_study_id