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    【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

    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

    申办单位信息
    申请人联系人
    申请人名称
    联系人邮箱
    联系人邮编

    联系人通讯地址
    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
    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
    研究负责人姓名
    试验机构

    N/A

    研究负责人电话
    研究负责人邮箱
    研究负责人邮编

    /

    联系人通讯地址

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