【ChiCTR2200065444】Integrated Multi-Component Service Model for Mild Cognitive Impairment

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基本信息

登记号

ChiCTR2200065444

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

2022-11-04

临床申请受理号

靶点

适应症

Mild cognitive impairment

试验通俗题目

Integrated Multi-Component Service Model for Mild Cognitive Impairment

试验专业题目

Integrated Multi-Component Service Model for Mild Cognitive Impairment Among Older Adults in Community and Primary Care

申办单位信息

申请人联系人

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申请人名称

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联系人邮箱

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联系人邮编

联系人通讯地址

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临床试验信息

试验目的

1. To establish an enhanced multi-component care model with collaborative care coordinated by nurse and supervised by family medicine academics with support from a multidisciplinary team of health professionals with the aim to prevent cognition decline and improve quality of life among Hong Kong older adults with or at high risk for MCI. 2. To establish a lower cost multi-component care model led by health professionals but supported by trained community workers with the aim to perform protocol-driven assessments and interventions to prevent cognition decline and improve quality of life among older adults with or at high risk for MCI. 3. To understand the effectiveness and cost-effectiveness of the above two models, in comparison with usual community practice (physical activity, cognitive activity, and psychosocial activity). 4. To understand the 1-year re-screening results for those screened negative at initial screening and risk factors of cognition deterioration to prepare for future service planning and allocation.

试验分类

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试验类型

随机平行对照

试验分期

其它

随机化

Computer-generated allocation sequencing will be done in blocks of twelve to ensure the balanced allocation of participants in each venue.

盲法

Single blind (Blind to assessors and statistician who conduct the analyses)

试验项目经费来源

Non-commercial

试验范围

目标入组人数

600

实际入组人数

第一例入组时间

2022-11-14

试验终止时间

2025-11-13

是否属于一致性

入选标准

1. Aged 60 years or above; 2. Having Montreal Cognitive Assessment Hong Kong version (HK-MoCA) score within 19-25 after adjusting for years of educational (+1 point if < 6 years) suggesting MCI; or at high risk for MCI (e.g., screened positive in SARC-F for sarcopenia (>= 4 points); or have handgrip strength below the cut-off points (< 26 for male, <18 for female); or have subjective memory complaint (reported memory loss and worried about it); or have diabetes or metabolic syndrome (a combination of diabetes, hypertension and obesity); or screened positive for depression (PHQ-2 >= 3 points).；

排除标准

1. A confirmed diagnosis of dementia; 2. One or more significant communicative impairments. Notes: Use of psychotropic medication does NOT constitute an exclusion criterion, but any use of anti-dementia and other psychotropic medications should be kept on a stable dosage for at least three months before enrolment and also throughout the project.；

研究者信息

研究负责人姓名

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试验机构

The Jockey Club School of Public Health and Primary Care, The Chinese University of Hong Kong

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研究负责人邮编

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