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

NCT02153346 | Completed Results

• 1 other identifier: 200347
• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma

Keywords

indirect cost; asthma

Outcome Measures

Primary Outcomes (3)

• Indirect Cost of Asthma Per Participant Per 3 Months at Baseline (BL) and 12-month Follow-up (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).

  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

  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.

  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

  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).

  BL and 12-month FUP

Secondary Outcomes (1)

• Work Productivity Loss as Assessed in Hours Using Work Productivity and Activity Impairment (WPAI) During the Specified Time Points

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

Study Arms (1)

Arm 1

OTHER

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; Other: Work productivity and activity impairment questionnaire

Interventions

Valuation of lost productivity questionnaire OTHER

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.

Arm 1

Work productivity and activity impairment questionnaire OTHER

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.

Arm 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Montreal, Quebec, H4J 1C5, Canada

Location

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Limitations and Caveats

Important limitations regarding sample size,generalizability and results interpretation.Data not reliable due to low numbers by strata. Changes in work status,full/part-time,and treatments or other factors influencing productivity were not accounted.

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2014
• First Posted: June 3, 2014
• Study Start: June 22, 2014
• Primary Completion: April 1, 2016
• Study Completion: April 22, 2016
• Last Updated: August 17, 2018
• Results First Posted: April 24, 2017

Record last verified: 2018-06

Locations

CA (1)