【ChiCTR2100052080】Lay health worker as an example of medical task-shifting: Design of a pragmatic randomized controlled trial for diabetes prevention in people living in inadequate housing

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基本信息

登记号

ChiCTR2100052080

试验状态

尚未开始

药物名称

药物类型

规范名称

首次公示信息日的期

2021-10-16

临床申请受理号

靶点

适应症

Diabetes

试验通俗题目

Lay health worker as an example of medical task-shifting: Design of a pragmatic randomized controlled trial for diabetes prevention in people living in inadequate housing

试验专业题目

Lay health worker intervention on diabetes management

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临床试验信息

试验目的

This is a pragmatic, wait-list randomized controlled trial to evaluate the impact of lay health worker intervention on the incidence and disease management of diabetes among people living in socially-inappropriate households. We hypotheses that the lay health worker intervention could significantly improve disease prognosis of people with risk to develop diabetes, who are living in socially-inappropriate housing using an example of Hong Kong Chinese population.

试验分类

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试验类型

连续入组

试验分期

Ⅰ期

随机化

N/A

盲法

N/A

试验项目经费来源

The Jockey Club Charity Trust

试验范围

目标入组人数

222

实际入组人数

第一例入组时间

2021-10-16

试验终止时间

2022-10-31

是否属于一致性

入选标准

This trial includes the major caregiver of households living in sub-divided flat units who are 1) responsible for the food preparation of the family, 2) ethnically Chinese and aged >= 18, 3) identified with >= 1 risk factor or symptoms for T2DM according to the Hong Kong Reference Framework for Diabetes Care for Adults in Primary Care Settings; 4) HKID holders, 5) able to communicate in Chinese or English; and 6) able to give consent. People who are cognitively incompetent, and whose co-living family members have already enrolled in this trial will be excluded. Hong Kong Reference Framework for Diabetes Care for Adults in Primary Care Settings is a well-established guideline adopted I in the primary care services in Hong Kong for screening people who are at risk to T2DM[15]. Eligible participants will be invited to participant in this study through partnering non-profit organizations (NPOs) that provided care services to low-income families living in socially-inappropriate housings in Hong Kong. Participants who are interested in the study will be invited to an initial health assessment, where a study information sheet and the ethics consent form will be explained to the participants in person, and participants will be allowed to consider their participation before offering consent.；

排除标准

People who are incapable to offer consent will be excluded.；

研究者信息

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N/A

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研究负责人邮编