NCT02153346

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

Completed NA Results posted Last updated 17 August 2018

What this trial tests

NA trial testing Valuation of lost productivity questionnaire in Asthma in 101 participants. Completed in 22 April 2016.

Timeline

22 June 2014

Primary endpoint
1 April 2016

22 April 2016

Quick facts

Lead sponsor	GlaxoSmithKline
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	other
Enrollment	101
Start date	22 June 2014
Primary completion	1 April 2016
Estimated completion	22 April 2016
Sites	1 location across Canada

Drugs / interventions tested

• Valuation of lost productivity questionnaire
• Work productivity and activity impairment questionnaire

Conditions studied

• Asthma — all drugs for Asthma →

Sponsor

GlaxoSmithKline — full company profile →

Who can join

18 and older, any sex, with Asthma. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Indirect Cost of Asthma Per Participant Per 3 Months at Baseline (BL) and 12-month Follow-up (FUP) Primary · 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 a

BL, CAA, n=52

Group	Value	95% CI
BD-Asthma/RESP	253.3	± 847.5

FUP, CAA, n=40

Group	Value	95% CI
BD-Asthma/RESP	70.4	± 157.6

BL,CPA,n=50

Group	Value	95% CI
BD-Asthma/RESP	16.9	± 78.8

FUP,CPA, n=39

Group	Value	95% CI
BD-Asthma/RESP	17.1	± 37.2

BL,CAA TCC, n=46

Group	Value	95% CI
BD-Asthma/RESP	183.3	± 648.2

FUP,CAA TCC,n=37

Group	Value	95% CI
BD-Asthma/RESP	76.10	± 162.64

BL,CPA TCC, n=46

Group	Value	95% CI
BD-Asthma/RESP	18.4	± 82.0

FUP,CPA TCC,n=37

Group	Value	95% CI
BD-Asthma/RESP	17.1	± 37.20

Indirect Cost of Asthma by Level of Asthma Control Per Participant Per 3 Months at BL and 12-month FUP Primary · 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 absen

BL, Partly controlled, CAA, n=9

Group	Value	95% CI
BD-Asthma/RESP	557.65	± 1380.41

FUP, Partly controlled, CAA, n=10

Group	Value	95% CI
BD-Asthma/RESP	171.66	± 266.70

BL, Partly controlled, CPA, n=10

Group	Value	95% CI
BD-Asthma/RESP	57.04	± 168.54

FUP, Partly controlled, CPA, n=10

Group	Value	95% CI
BD-Asthma/RESP	32.51	± 50.72

BL, Partly controlled, CAA TCC, n=8

Group	Value	95% CI
BD-Asthma/RESP	585.29	± 1473.06

FUP, Partly controlled, CAA TCC possible, n=10

Group	Value	95% CI
BD-Asthma/RESP	171.66	± 266.70

BL,Partly controlled, CPA TCC, n=8

Group	Value	95% CI
BD-Asthma/RESP	71.30	± 188.04

FUP, Partly controlled, CPA TCC, n=10

Group	Value	95% CI
BD-Asthma/RESP	32.51	± 50.72

Indirect Cost of Asthma by Level of Asthma Severity Per Participant Per 3 Months at BL and 12-month FUP Primary · 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, Mild, CAA, n=1

Group	Value	95% CI
BD-Asthma/RESP	154.36	± 0.00

FUP, Mild, CAA, n=1

Group	Value	95% CI
BD-Asthma/RESP	303.74	± 0.00

BL, Mild, CPA, n=1

Group	Value	95% CI
BD-Asthma/RESP	0.00	± 0.00

FUP, Mild, CPA n=1

Group	Value	95% CI
BD-Asthma/RESP	0.00	± 0.00

BL, Mild, CAA TCC, n=1

Group	Value	95% CI
BD-Asthma/RESP	154.36	± 0

FUP, Mild, CAA TCC, n=1

Group	Value	95% CI
BD-Asthma/RESP	303.74	± 0

BL, Mild, TICA, n=1

Group	Value	95% CI
BD-Asthma/RESP	154.36	± 0.00

FUP, Mild, TICA, n=1

Group	Value	95% CI
BD-Asthma/RESP	303.74	± 0.00

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

BL, HMA, last 7 days, n=56

Group	Value	95% CI
BD-Asthma/RESP	0.4	± 2.8

4-Month FUP, HMA, last 7 days, n=49

Group	Value	95% CI
BD-Asthma/RESP	2.4	± 9.0

8-Month FUP, HMA, last 7 days, n=37

Group	Value	95% CI
BD-Asthma/RESP	0.9	± 5.3

12-Month FUP, HMA, last 7 days, n=44

Group	Value	95% CI
BD-Asthma/RESP	0.0	± 0.3

BL, HMO, last 7 days, n=56

Group	Value	95% CI
BD-Asthma/RESP	3.3	± 9.0

4-Month FUP, HMO, last 7 days, n=49

Group	Value	95% CI
BD-Asthma/RESP	4.2	± 9.1

8-Month FUP, HMO, last 7 days, n=37

Group	Value	95% CI
BD-Asthma/RESP	6.1	± 12.8

12-Month FUP, HMO, last 7 days, n=44

Group	Value	95% CI
BD-Asthma/RESP	4.4	± 10.5

Sponsor's own 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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.