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Indirect Cost of Illness Study of Moderate and Severe Asthma in Quebec

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ClinicalTrials.gov Identifier: NCT02153346
Recruitment Status : Completed
First Posted : June 3, 2014
Results First Posted : April 24, 2017
Last Update Posted : August 17, 2018
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Asthma Other: Valuation of lost productivity questionnaire Other: Work productivity and activity impairment questionnaire Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 101 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Indirect Cost of Illness Study of Moderate and Severe Asthma in Quebec
Study Start Date : June 22, 2014
Actual Primary Completion Date : April 1, 2016
Actual Study Completion Date : April 22, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arm Intervention/treatment
Arm 1
Intervention 1 & 2 are associated with Arm 1. All patients enrolled in the study will possibly receive both the valuation of lost productivity and work productivity and activity impairment questionnaires, which are outside of the patient's usual care.
Other: Valuation of lost productivity questionnaire
A new, composite questionnaire that can be used to assess the impact of health conditions on lost productivity in monetary units. It measures absenteeism, presenteeism, and non work activities.

Other: Work productivity and activity impairment questionnaire
A six item questionnaire used as a patient-reported quantitative assessment of the amount of absenteeism, presenteeism, and daily activity impairment attributable to a specific health problem.




Primary Outcome Measures :
  1. Indirect Cost of Asthma Per Participant Per 3 Months at Baseline (BL) and 12-month Follow-up (FUP) [ Time Frame: BL and at 12-month FUP ]
    Participants completed questionnaires within 2 weeks post-recruitment, 4, 8 and 12 months to measure indirect cost of disease, specifically related to productivity. The following questionnaires were used: WPAI helps to determine presenteeism, absenteeism, and total cost calculation (TCC) possible (number of days during the year of study), while VOLP is used to assess the impact of health conditions on lost productivity in monetary units (United states dollars). The following parameters were calculated: Cost of absenteeism due to asthma (CAA), cost of presenteeism due to asthma (CPA), cost of absenteeism due to asthma in whom TCC was possible (CAA TCC), cost of presenteeism due to asthma in whom TCC was possible (CPA TCC), and total indirect cost due to asthma (TICA).

  2. Indirect Cost of Asthma by Level of Asthma Control Per Participant Per 3 Months at BL and 12-month FUP [ Time Frame: BL and 12-month FUP ]
    Costs of asthma are greater when the asthma is sub-optimally managed and controlled and varies depending on the par. asthma control. Asthma control was assessed using the Asthma Control Questionnaire (ACQ) and par. were asked to recall their experiences during the previous week and respond to the 6 specified questions on a 7-point Likert scale (0=well-controlled; 6=maximum impairment [poorly controlled]; a score of ≤0.75 indicates well controlled symptoms. The following parameters were presented: Cost of absenteeism due to asthma (CAA), cost of presenteeism due to asthma (CPA), cost of absenteeism due to asthma in whom TCC was possible (CAA TCC), cost of presenteeism due to asthma in whom TCC was possible (CPA TCC), and total indirect cost due to asthma (TICA). Only 59 par. were active workers. When stratified by asthma control and severity each stratum had a sample less than 59. Although results are presented. data may not be reliable due to the low number of par. in each stratum.

  3. Indirect Cost of Asthma by Level of Asthma Severity Per Participant Per 3 Months at BL and 12-month FUP [ Time Frame: BL and 12-month FUP ]
    Costs of asthma may vary depending on the participant's asthma severity. Asthma severity was based on the standard definitions for severity and ACQ scores: Mild (<0.75), Moderate (>0.75) and Severe (any ACQ score). The following parameters were presented: Cost of absenteeism due to asthma (CAA), cost of presenteeism due to asthma (CPA), cost of absenteeism due to asthma in whom TCC was possible (CAA TCC), cost of presenteeism due to asthma in whom TCC was possible (CPA TCC), and total indirect cost due to asthma (TICA).


Secondary Outcome Measures :
  1. Work Productivity Loss as Assessed in Hours Using Work Productivity and Activity Impairment (WPAI) During the Specified Time Points [ Time Frame: At BL, 4-Month, 8-Month and 12-Month FUP ]
    WPAI is a self-administered instrument to determine the degree to which asthma affected work productivity while at work and affected activities outside of work in the last 7 days and yields 4 types of scores: Absenteeism (work time missed/missed due to other reasons); Presenteeism (actual time worked); Work Productivity Loss (affected productivity while working); and Activity Impairment (affected regular activities). The following parameters were presented: Hours (Hrs) missed due to asthma (HMA), Hrs missed due to other reasons (HMO), and Hrs actually worked (HAW); all in the last 7 days.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Part of the BD-Asthma registry
  • Age 18 years and older
  • Patients who signed consent for research with the BD-Asthma registry and signed consent to participate in the indirect cost study.
  • Must be alive at the time of recruitment

Exclusion Criteria:

• Patients with a diagnosis of COPD recorded in BD-Asthma at the time of enrolment.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02153346


Locations
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Canada, Quebec
GSK Investigational Site
Montreal, Quebec, Canada, H4J 1C5
Sponsors and Collaborators
GlaxoSmithKline
Investigators
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Study Director: GSK Clinical Trials GlaxoSmithKline

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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT02153346     History of Changes
Other Study ID Numbers: 200347
First Posted: June 3, 2014    Key Record Dates
Results First Posted: April 24, 2017
Last Update Posted: August 17, 2018
Last Verified: June 2018
Keywords provided by GlaxoSmithKline:
indirect cost
asthma
Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases