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临床试验/NCT05389540
NCT05389540已完成不适用

Overview of Disease Burden in Rural South and Southeast Asia: A Cross-sectional Household Health Survey With Questionnaire Interviews and Selected Laboratory Tests

University of Oxford4 个研究点 分布在 4 个国家目标入组 4,747 人开始时间: 2022年10月3日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
4,747
试验地点
4
主要终点
Prevalence of Plasmodium spp. by PCR

研究概览

简要总结

A cross-sectional household survey with two-stage cluster-randomized sampling. This cross-sectional household survey design to recruit a random sample of households that is representative for each of the study sites. From the selected households, all consenting, household members will be included in the study.

This study is funded by the UK Wellcome Trust. The grant reference number is 215604/Z/19/Z

详细描述

371 households will be randomly selected from each site in Bangladesh, Cambodia, Myanmar, and Thailand. Assuming each household has an average of 4.5 members and all members will be sampled, 1500 participants will be recruited per site. This sample size allows for the overall prevalence estimation of key survey indicators with 95% confidence and 5% degree of precision.

The survey components include questionnaire interview, physical examination, blood sample collection, and point of care (PoC) tests. The questionnaire interview will collect information on household characteristics, members' disability, presence or history of disease, risk factors, self-perceived quality of life, and health seeking behaviour. For women, questions about reproductive health and antenatal care, and for young children, vaccination coverage and achievement of child development goals, will also be assessed.

For physical examinations, tympanic temperature, weight and height will be measured in all household members, mid-upper arm circumference in young children, and blood pressure in adults. Blood sample will be collected from all participants aged 6 months and above. Venous blood samples will be collected from participants aged 5 years and older, and dried blood spot will be collected from children under 5 years. Samples will be shipped to a central laboratory and analysed. Haemoglobin PoC will be administered to all participants.

All data will be collected directly on an electronic case report form using tablets, and uploaded to an electronic database.

研究设计

研究类型
Observational
观察模型
Ecologic Or Community
时间视角
Cross Sectional

入排标准

性别
All
接受健康志愿者

入选标准

  • All members of the selected households at the time of the survey; and able to provide informed consent.

排除标准

  • Adults or children whose parent/guardian/ caretaker are unable or unwilling to provide informed consent.

结局指标

主要结局

Prevalence of Plasmodium spp. by PCR

时间窗: Upon enrollment

Prevalence of chronic Hepatitis B and C

时间窗: Upon enrollment

Prevalence of reported disability

时间窗: Upon enrollment

Prevalence of long-lasting antibodies (IgG) against selected causes of non-malaria febrile illnesses

时间窗: Upon enrollment

Lifetime prevalence of reported injury or death caused by an accident

时间窗: Upon enrollment

Prevalence of selected non-communicable diseases (e.g. diabetes, chronic obstructive pulmonary diseases, stroke) according to self-reported disease history and laboratory tests

时间窗: Upon enrollment

Self-rated overall health status

时间窗: Upon enrollment

Questionnaire evaluation of health-related quality of life

时间窗: Upon enrollment

Prevalence of underweight and overweight, raised blood pressure and total cholesterol

时间窗: Upon enrollment

Prevalence of self-reported tobacco, alcohol, and other substitute use among the population aged 15 and above

时间窗: Upon enrollment

次要结局

  • Prevalence of reported exclusive breast feeding among children < 5 years(Upon enrollment)
  • Education level, marital status, and occupation(Upon enrollment)
  • Evaluation of household wealth quartile according to self-reported household characteristics(Upon enrollment)
  • Self-reported antenatal care coverage among women who have ever given birth(Upon enrollment)
  • Reported vaccination coverage among children < 3 years(Upon enrollment)
  • Proportion of population self-reported having sought for medical care in the past month, and care providers visited(Upon enrollment)
  • Prevalence of children aged 3-4 years who have reached early child development milestones, reported by caretaker(Upon enrollment)
  • Reported illness in the last month and type of illness(Upon enrollment)
  • Prevalence of IgM antibodies against selected acute non-malaria causes of febrile illness(Upon enrollment)
  • Self-reported health-related household characteristics (e.g. household cooking fuel, source of drinking water, possession of mosquito net)(Upon enrollment)
  • Presence of self-reported symptoms or diagnosed illness besides the outcome measures of the primary objectives(Upon enrollment)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

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