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临床试验/NCT03243110
NCT03243110已完成不适用

The Economic Burden of Asthma in Canada

University of British Columbia0 个研究点目标入组 613 人开始时间: 2010年12月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
613
主要终点
Costs of asthma in BC and Canada per patient

研究概览

简要总结

The study will consist of three phases: Phase A: General population survey for estimation of the prevalence of asthma, and prospective collection of resource utilization and quality-of-life data for 12 months, Phase B: comparison of healthcare resource usage collected prospectively to the data collected using administrative data in the population recruited in Phase A, and Phase C: Economic modeling of asthma to extrapolate the findings across Canada and into the future years.

详细描述

Phase A: This phase will be a prospective cohort study of randomly chosen residents of two census subdivisions of BC with a self-reported physician diagnosis of asthma. The study participants will be recruited via landline and cell phone-based random digit dialing across two regions in British Columbia: the Census Sub-Division of the city of Vancouver and the Census Division of Central Okanagan. The target area was chosen based on Census Sub-Division as it provides a clear definition of the target population for whom demographic and socioeconomic data is available through national and provincial census and surveys. The Okanagan Census Sub-Division was particularly chosen as it provides data on both urban and rural populations (18.6% rural population in 2006). According to 2006 census profile, the population of these two Census Sub-Divisions is, respectively, 578,041 and 162,276. Accordingly, about 78% of participants would be recruited from Vancouver, and 22% from Okanagan. The study will randomly sample participants from all the area codes in these regions. The target population will include household residents residing in telephone exchanges within the target Census Sub-Divisions. Random digit dialing will be geographically stratified with an associated sample weight that will approximate a probability sample of the individuals in the population. Previous studies have shown that acceptably high response rates can be achieved among Canadian participants with asthma.

Random digit dialing samples have been shown to be more representative than population samples drawn using alternative methods such as telephone directories or electronic white pages. However, random digit dialing is not free of bias. Non-random non-response is an issue, and it has been shown that reducing the non-response rate may directly reduce non-response bias. Non-responders in random digit dialing may not have been contacted because the non-responders work multiple minimum-wage jobs. The investigators will place multiple calls and leave messages on answering machines. Random digit dialing is also subject to no-telephone bias - households without telephones are out of reach by random digit dialing, and the households without telephones probably differ in socioeconomic status than the overall population. However, for the urban, suburban, and semi-rural sub-populations within British Columbia, telephone coverage is almost universal.

Inclusion of cell phones in random digit dialing is an attempt to mitigate such biases and increase the fraction of population covered by sampling. More importantly, the inclusion of cell phones is likely to result in inclusion of participants that might be absent from landline random digit dialing (younger and more educated groups) thus mitigating the sampling bias of random digit dialing. Cell phone random digit dialing is an active area of research and it is too soon to know with confidence what should and should not be regarded as a "Best Practice". For inclusion of cell phones in random digit dialing, the investigators will use the "Screening Approach". In this approach the interview is only conducted with participants sampled via the cell phone frame who do not have a landline, thus excluding numbers from the cell phone sample in the overlap (i.e., screening out the participants with both a cell phone and a landline). In this alternative sampling design, participants who have at least one household landline telephone and use at least one cell phone would be eligible for inclusion only from the landline frame. This decreases the bias due to higher probability of sampling from households who have both a landline and cell phone.

The study will employ the Waksberg method of random digit sampling. In this method, all telephone numbers are initially split into blocks of equal size, called "primary sampling units". The primary sampling unit will be a mixture of landlines and cell phones. One randomly selected telephone number is called from each selected primary sampling unit. When a residential connection is reached in the first stage, the primary sampling unit qualifies for inclusion in the second stage.

Respondents will be asked the following question: "Is there a member of the household between ages of 1 to 85 who has had asthma ever diagnosed by a physician". If the response is affirmative the study assistant will ask if the participant in question can continue the conversation directly (parents in case of children). Eligible participants (or in the case of children their parents or guardians) will be informed of the objectives of the study, verbally consented, and then screened for eligibility based on age and history of asthma. Participants who meet eligibility criteria and verbally consent over the phone will be asked to come to the study laboratory (one at Vancouver and one at Kelowna, corresponding to the two Census Sub-Divisions) and the participant will receive a detailed explanation of the study and the study consent form at that time.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
1 Year 至 85 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patient must state that they have had a diagnosis of asthma by a physician. In addition, the patient must have had a self-reported health care interaction related to asthma (physician visit, ED visit, hospitalization) in the past 5 years.
  • Patient must be 1 to 85 years old.

排除标准

  • Patients unable to provide informed consent due to language difficulties or cognitive impairment.
  • Patients who have a greater than 10 pack-year smoking history (this will exclude patients with possible COPD).
  • Patients who know that they will be moving out of the province within 12 months of study entry.
  • Patients in whom metacholine challenge test is contraindicated due to non-asthma-related reasons (e.g. patients with cerebral aneurysm, pregnant and breastfeeding participants).

结局指标

主要结局

Costs of asthma in BC and Canada per patient

时间窗: September 2013

Costs per patients will be calculated by multiplying the amount of healthcare resources used by the corresponding unit costs. The investigators will adjust all unit costs to 2010 Canadian dollar according to the medical care component of the Consumer Price Index(42). The lowest price for available (generic drugs if exists) versions of medications will be used based on province-specific data.

次要结局

  • Calculating quality of life of participants with asthma using the EuroQol's EQ-5D Questionnaire(February 2017)
  • Calculating quality of life of participants with asthma using the Asthma Quality of Life Questionnaire(January 2017)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mark Fitzgerald

Professor

University of British Columbia

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The Economic Burden of Asthma in Canada | 临床试验