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临床试验/NCT03604939
NCT03604939已完成不适用

Improving Access to Control of Diseases for Women

International Agency for Research on Cancer2 个研究点 分布在 1 个国家目标入组 1,200 人开始时间: 2017年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
1,200
试验地点
2
主要终点
Outcomes of the questionnaire survey 1/5

研究概览

简要总结

The aim of this study is to evaluate the feasibility and acceptability of the model of delivering CHW-driven home-based comprehensive NCD control services aimed to prevent premature deaths from cardio-vascular diseases, stroke and breast, cervix and oral cancers in the hard-to-reach women.

详细描述

Specific objectives of this study are the evaluation of:

  1. The social, cultural and behavioral factors that impact the uptake of the NCD control services among rural women using the Rapid Assessment, Response and Evaluation (RARE) approach;
  2. The feasibility and acceptability of the strategy to deliver the following NCD control services to the rural women at their homes by the trained CHWs:
  • Counselling of the tobacco habitués to give up the practice
  • Early detection of hypertension and diabetes to ensure prompt and regular treatment
  • Creating breast awareness and ensuring access to prompt diagnosis and treatment of the women with symptoms suggestive of breast cancer
  • Screening for cervical cancer by self-collected HPV test and ensuring prompt treatment of screen detected precancers and cancers
  • Screening of the habitual tobacco/alcohol users for oral cancer by OVE and ensuring prompt treatment of screen detected precancers and cancers

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Screening
盲法
None

入排标准

年龄范围
30 Years 至 60 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Women between 30 to 60 years residing in the villages of the Gogunda block in the district of Udaipur in Rajasthan, India, will be eligible to participate.

排除标准

  • Women suffering from debilitating illnesses, pregnant women and women refusing to participate will be excluded.

结局指标

主要结局

Outcomes of the questionnaire survey 1/5

时间窗: 1 year

proportion of the participants who know about the adverse effect of smoking, chewing tobacco and consuming alcohol on health in general and NCDs in particular

Outcomes of the questionnaire survey 5/5

时间窗: 1 year

proportion of the participants with a diagnosis of cancer who adhere to the treatment advised

NCD Screening study 1/11

时间窗: 1 year

screen positivity - proportion of the screened participants detected to have high blood pressure

NCD Screening study 2/11

时间窗: 1 year

screen positivity - proportion of the screened participants detected to have high BMI

NCD Screening study 5/11

时间窗: 1 year

screen positivity - proportion of the screened participants detected to have abnormal visual examination test

NCD Screening study 11/11

时间窗: 1 year

positive predictive values of further assessment - proportion of participants with confirmed visual premalignant and malignant lesions on examination and/or biopsy among those assessed for positive visual examination

Outcomes of the questionnaire survey 4/5

时间窗: 1 year

proportion of the participants with a diagnosis of diabetes who adhere to the treatment advised

NCD Screening study 3/11

时间窗: 1 year

screen positivity - proportion of the screened participants detected to have abnormal HPV detection test

NCD Screening study 9/11

时间窗: 1 year

positive predictive values of further assessment - proportion of participants with confirmed cervical neoplasias on colposcopy and/or biopsy among those assessed for positive HPV test

Outcomes of the questionnaire survey 2/5

时间窗: 1 year

proportion of the participants who know about the common NCDs including cancers and their early symptoms

Outcomes of the questionnaire survey 3/5

时间窗: 1 year

proportion of the participants with a diagnosis of hypertension who adhere to the treatment advised

NCD Screening study 4/11

时间窗: 1 year

screen positivity - proportion of the screened participants detected to have abnormal oral examination test

NCD Screening study 8/11

时间窗: 1 year

positive predictive values of further assessment - proportion of participants with confirmed diabetes among those assessed for high sugar

NCD Screening study 6/11

时间窗: 1 year

compliance to further assessment - proportion of screen positive participants undergoing further assessment at the primary health center or at the hospital

NCD Screening study 7/11

时间窗: 1 year

positive predictive values of further assessment - proportion of participants with confirmed diagnosis of hypertension among those assessed for high BP

NCD Screening study 10/11

时间窗: 1 year

positive predictive values of further assessment - proportion of participants with confirmed oral premalignant and malignant lesions on examination and/or biopsy among those assessed for positive oral examination

次要结局

  • effect of different participant characteristics on the final diagnosis of hypertension and diabetes using multivariate analysis(1 year)

研究者

发起方
International Agency for Research on Cancer
申办方类型
Other
责任方
Sponsor

研究点 (2)

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