Last updated: 07/17/2024 17:00:25

Indirect cost of illness study of moderate and severe asthma in Quebec

GSK study ID
200347
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Indirect cost of illness study of moderate and severe asthma in Quebec
Trial description: Rationale
Asthma is a chronic inflammatory disorder of the airways affecting persons of all ages and is recognized as one of the most common chronic diseases. Canada has one of the highest asthma prevalence rates in the world (8.5%, aged 12 and over) and it is a major cause of hospitalization. The cost of asthma varies dramatically across disease severity, and it is expected that these costs are greater when the condition is sub-optimally managed and controlled. Although a number of publications have been reported on the economic burden of asthma, there is a lack of information on the cost of asthma based on disease severity and level of disease control in Canada. The proposed study aims to i) estimate the annual indirect cost of asthma and ii) the impact of asthma on absenteeism, presenteeism and work productivity in Canada. This information is essential to further quantify the burden of asthma on patients and the healthcare system in the Canadian setting.
Overall Objectives
The overall objective of this study is to describe the impact of asthma on patients with moderate to severe asthma and to estimate the indirect costs of asthma care in asthmatic patients followed in tertiary clinics specialized in the field of asthma in Quebec, Canada.
Study Design
A prospective cohort study will be conducted to measure the indirect economical burden of asthma on patients. Patients will be selected and recruited from the BD-Asthma registry and followed prospectively for 1 year. Recruited patients will be asked to complete questionnaires at regular intervals for 1 year to measure indirect cost of disease, using the Valuation of lost productivity (VOLP) questionnaire.
Data Collected
For each patient, the following data will be collected
• Patient demographics
• Age
• Sex
• Income
• Level of education
• Smoking
• Disease management and Treatment utilization in the year prior to recruitment
• Physician visits and follow up
• Hospitalizations (number and total days)
• Emergency room visits
• Disease characteristics
• Asthma history
• Year of first diagnosis of asthma severity
• Asthma Control Questionnaire score
• Lung function measures
Data Analysis Methods
For each participant, the percentage of time missed from work over a year will be calculated. We will use the human capital approach to calculate the costs of asthma due to lost productivity, incorporating both absenteeism and presenteeism in the calculation of the productivity loss. We will calculate the number of work days in which the person was unable to attend the workplace, and the number of days and percentage of time lost during the days the person’s work was affected by their asthma. The fraction of time lost from work in the past year will be multiplied by the average income in Quebec. Finally, this value will be multiplied by the coefficient generated by the VOLP, which reflects the relative value of the productivity loss. In addition, we will calculate the VOLP multiplier for each participant which, combined with the percentage of time missed from work, will create a measure of productivity loss adjusted for the relative importance and replace-ability of the participant’s profession.
Sample Size and Power
One hundred subjects will be randomly selected from the BD-Asthma registry.
Limitations
The study population may not be representative of the general asthma population, as moderate to severe asthma will be over represented in these tertiary centers.
Primary purpose:
Other
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Not applicable
Primary outcomes:

Indirect cost of asthma per participant per 3 months at Baseline (BL) and 12-month follow-up (FUP)

Timeframe: BL and at 12-month FUP

Indirect cost of asthma by level of asthma control per participant per 3 months at BL and 12-month FUP

Timeframe: BL and 12-month FUP

Indirect cost of asthma by level of asthma severity per participant per 3 months at BL and 12-month FUP

Timeframe: BL and 12-month FUP

Secondary outcomes:

Work Productivity Loss as assessed in hours using Work Productivity and Activity Impairment (WPAI) during the specified time points

Timeframe: At BL, 4-Month, 8-Month and 12-Month FUP

Interventions:
  • Other: Valuation of lost productivity questionnaire
  • Other: Work productivity and activity impairment questionnaire
  • Enrollment:
    101
    Primary completion date:
    2016-22-04
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Afisi Ismaila, Lucie Blais, Tam Dang-Tan, Shiyuan Zhang, Amélie Forget, Fatima Kettani, Diane Corriveau, Catherine Lemiere.Direct and indirect costs associated with moderate and severe asthma in Quebec, Canada.Can J Respir Critical Care Sleep.2019;3(3):134-142 DOI: 10.1080/24745332.2018.1544839
    Medical condition
    Asthma
    Product
    fluticasone propionate, fluticasone propionate/salmeterol, salbutamol, salmeterol
    Collaborators
    Not applicable
    Study date(s)
    June 2014 to April 2016
    Type
    Interventional
    Phase
    Not applicable

    Participation criteria

    Sex
    Female & Male
    Age
    18+ years
    Accepts healthy volunteers
    No
    • Part of the BD-Asthma registry
    • Age 18 years and older
    • Patients with a diagnosis of COPD recorded in BD-Asthma at the time of enrolment.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Montreal, Québec, Canada, H4J 1C5
    Status
    Study Complete

    Study documents

    Protocol
    Available language(s): English

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Results posted on ClinicalTrials.gov

    Recruitment status
    Study complete
    Actual primary completion date
    2016-22-04
    Actual study completion date
    2016-22-04

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

    Additional information about the trial

    Additional information
    Not applicable
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