AsthmaNCT02153346
Indirect Cost of Illness Study of Moderate and Severe Asthma in Quebec
A study testing Valuation of lost productivity questionnaire and Work productivity and activity impairment questionnaire in people with Asthma, run by GlaxoSmithKline at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Asthma
- What is being tested?
- Valuation of lost productivity questionnaire and Work productivity and activity impairment questionnaire
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 1 siteCanada
- Study dates
- 22 Jun 2014to 22 Apr 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Patients with a diagnosis of COPD recorded in BD-Asthma at the time of enrolment.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
Read the detailed 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. With a continuously increasing prevalence and associated morbidity and mortality, asthma poses a tremendous clinical and economic burden on healthcare systems and on the society as a whole.
According to a report published by the Global Initiative for Asthma (GINA) in 2004 an estimated 300 million people in the world have asthma, and more than 2 million Canadians have asthma. 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 direct and indirect costs associated with asthma are expected to rank among the highest for chronic diseases due to the high prevalence in conjunction with the significant healthcare utilization associated with the disease and the considerable restrictions asthma imposes on the physical, emotional, social, and professional lives of sufferers. 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. Moreover, no study has compared the annual cost of uncontrolled and "well-controlled" asthma patients. Although population-level direct costs have been previously reported through the use of administrative healthcare databases in various provinces, these databases cannot provide clinical data and are limited to subjects who have a public drug insurance plan.
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.
Primary objectives
- To estimate the annual indirect costs of asthma in asthmatic patients followed in tertiary clinics specialized in the field of asthma in Quebec, Canada
- To estimate the annual indirect cost of asthma by asthma severity and control status (uncontrolled, partly controlled, well controlled) of asthmatic patients followed in tertiary clinics specialized in the field of asthma in Quebec, Canada
Secondary objectives
- To determine the impact of asthma on work productivity 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.
Recruitment of patients All eligible patients from the BD-asthma will be invited to participate. Patients approached for participation will be provided verbal and written information on the project and, if the patient agrees to participate, they will be asked to sign the participation consent form. The forms will be collected by the research coordination centre (either at the clinic or the physicians' office or directly with the patient). All recruited eligible patients that have provided their consent will be included in this study.
Source Population The population is defined as individuals diagnosed with asthma (ICD9 codes 493.x).
Study Population The study population is defined as having had at least one diagnosis of asthma (ICD9 codes 493.x) recorded in the BD Asthma database between February 2010 and February 2012.
Clinical information Patient characteristics and clinical information on asthma will be obtained from the BD-asthma database.
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
- Being tested
- Valuation of lost productivity questionnaire, Work productivity and activity impairment questionnaire
- Keywords
- indirect cost, asthma
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Valuation of lost productivity questionnaireOther
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.
Work productivity and activity impairment questionnaireOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Valuation of lost productivity questionnaire; Other: Work productivity and activity impairment questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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).
Measured: 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
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.
Measured: At BL, 4-Month, 8-Month and 12-Month FUP
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2014 (estimated)
- Study start22 Jun 2014
- Primary completion1 Apr 2016
- Study completion22 Apr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02153346
- Sponsor's protocol ID
- 200347
- Status last verified
- Jun 2018
- First submitted
- 22 May 2014
- Last updated
- 17 Aug 2018
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Indirect Cost of Illness Study of Moderate and Severe Asthma in Quebec
- ClinicalTrials.gov ID
- NCT02153346
- Acronym / sponsor ID
- 200347
- Conditions
- Asthma
- Keywords
- indirect cost, asthma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 22 Jun 2014
- Primary completion
- 1 Apr 2016 (actual)
- Study completion
- 22 Apr 2016 (actual)
- First posted
- 3 Jun 2014 (estimated)
- Results
- Posted 24 Apr 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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. With a continuously increasing prevalence and associated morbidity and mortality, asthma poses a tremendous clinical and economic burden on healthcare systems and on the society as a whole.
According to a report published by the Global Initiative for Asthma (GINA) in 2004 an estimated 300 million people in the world have asthma, and more than 2 million Canadians have asthma. 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 direct and indirect costs associated with asthma are expected to rank among the highest for chronic diseases due to the high prevalence in conjunction with the significant healthcare utilization associated with the disease and the considerable restrictions asthma imposes on the physical, emotional, social, and professional lives of sufferers. 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. Moreover, no study has compared the annual cost of uncontrolled and "well-controlled" asthma patients. Although population-level direct costs have been previously reported through the use of administrative healthcare databases in various provinces, these databases cannot provide clinical data and are limited to subjects who have a public drug insurance plan.
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.
Primary objectives
- To estimate the annual indirect costs of asthma in asthmatic patients followed in tertiary clinics specialized in the field of asthma in Quebec, Canada
- To estimate the annual indirect cost of asthma by asthma severity and control status (uncontrolled, partly controlled, well controlled) of asthmatic patients followed in tertiary clinics specialized in the field of asthma in Quebec, Canada
Secondary objectives
- To determine the impact of asthma on work productivity 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.
Recruitment of patients All eligible patients from the BD-asthma will be invited to participate. Patients approached for participation will be provided verbal and written information on the project and, if the patient agrees to participate, they will be asked to sign the participation consent form. The forms will be collected by the research coordination centre (either at the clinic or the physicians' office or directly with the patient). All recruited eligible patients that have provided their consent will be included in this study.
Source Population The population is defined as individuals diagnosed with asthma (ICD9 codes 493.x).
Study Population The study population is defined as having had at least one diagnosis of asthma (ICD9 codes 493.x) recorded in the BD Asthma database between February 2010 and February 2012.
Clinical information Patient characteristics and clinical information on asthma will be obtained from the BD-asthma database.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Other | Other: Valuation of lost productivity questionnaire, Other: Work productivity and activity impairment questionnaireIntervention 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Patients with a diagnosis of COPD recorded in BD-Asthma at the time of enrolment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Valuation of lost productivity questionnaireA 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 | Arm 1 |
| Work productivity and activity impairment questionnaireA 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. | Other | Arm 1 |
Primary outcome
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).
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.
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).
1 secondary outcome
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Valuation of lost productivity questionnaire and Work productivity and activity impairment questionnaire in people with Asthma, run by GlaxoSmithKline at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Apr 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2018.